ASGCT CEO David Barrett Previews the Upcoming Conference in Boston

The 29th American Society of Gene & Cell Therapy (ASGCT) meeting kicks off in Boston next week. The annual event will be a whirlwind of sessions, keynotes, fireside chats, posters, and exhibitors.

For the second year in a row, GEN spoke with David Barrett, JD, who has been the CEO of ASGCT since 2016. In this interview, we discuss his perspective on the event, if there is anything new that attendees should be looking out for, and what he, personally, is most looking forward to.

This interview has been edited for length and clarity.

LeMieux: The ASGCT meeting is an annual event. What are some of the things that will make this year’s meeting special?

Barrett: There is a lot that is special this year. First and foremost, it feels like a bit of a homecoming which is really exciting. The last time we were in Boston was in 2008. And Boston is a city and community where gene therapy, biotech, and research are all located. You can feel it when you’re in Cambridge and I think you are absolutely going to feel that when you’re inside the convention center.

The fact that the meeting is in Boston this year is also special for me because one of the very first things I did when I joined ASGCT in 2016, was to source the location for the 2020 annual meeting at the Hynes Convention Center in Boston. I was very excited and it was the first time we were going to take up an entire convention center. But that meeting, of course, did not happen; it had to be canceled because of COVID. So that makes this meeting in Boston particularly special. We finally get to have the meeting in Boston that I’ve been hoping for since 2016!

And we are growing. We are at the bigger of the two convention centers in Boston. We are going to surpass the total number of people that we had last year and I have every expectation that we’ll see significant growth year over year.

As far as other things that are that are new and interesting this year… I said this last year, but it’s worth adding it again—the science is always different. It is very consistent that we will have great science every year, and it is a wonderfully fun question mark of what exactly that science is going to look like. It’s always exciting because the science is always different year after year. So, by its very nature, it will be an exciting new conference this year.

Also, we’ll have a puppy park in the exhibit hall, so that’s really fun!

LeMieux: What are some things that will be highlighted at the meeting that ASGCT has been working on over the past year?

Barrett: ASGCT has done a lot this year. There is a lot that we have been very vocal about so far, and there is a lot that we’ll be sharing during the annual meeting.

Number one is that we partnered with Orphan Therapeutics Accelerator (OTXL) to found CGTxchange—the first and only clearing house and marketplace of its kind for cell and gene therapy assets. It is being built as we speak and we’ll have some exciting announcements during the annual meeting about assets that will hopefully be in the CGTxchange by that point. It is the culmination of a lot of work on what to do about commercially pre-viable (not non-viable) cell and gene therapies and the work that we’re doing to make those more commercially possible.

Also, ASGCT is hosting its Momentum Gala—the first formal gala at our annual meeting. That event has resonated really well with sponsors and donors. In fact, it is sold out! That event is going to be used to celebrate the launch of ASGCT Foundation, which is a separately incorporated 501C3 charitable foundation to support ASGCT’s mission to advance early career researchers and enable the development of cell and gene therapies. Also at the gala, we’ll be announcing some new initiatives to support patient access and reduce barriers to diagnosis, clinical trial participation, and treatment with cell and gene therapies.

Another major thing that’s going on is a considerable expansion of our educational activities. We recently launched a new e-learning tool and platform—the ASGCT Learning Center—a really fun project that we’ve been working on to expand how we we are getting new content to our new and expanding audiences.

We recognize that we have a really broad audience at ASGCT that is made up of cell and gene therapy basic science researchers, translational researchers, physician scientists and others in the ecosystem of drug development and administration for cell and gene therapies. And we’re looking at new ways to provide content that can help satisfy the learning needs of that really broad audience. The learning center is a big tool in our quiver to be able to do that.

LeMieux: What do you hope people take away from the meeting?

Barrett: I hope they take away a couple of things… number one, I hope they take knowledge, education, and awareness of what’s going on in the space and what has been happening over the course of the last 12 months. I hope that they take that back to their individual place of work. And I hope that, generally speaking, we fulfill our mission by expanding that knowledge base among all of the stakeholders in cell and gene therapy. Another thing that I hope people take away from this is that, after a lot of ups and downs and undulations in this field over the course of the past two to three years, that there is an extraordinary sense of excitement about the next phases in the development of cell and gene therapy drugs.

We have some really exciting new regulatory pathways. We have a lot of development of personalized gene editing technologies and techniques that can bring gene therapies much more quickly and effectively to patients who need them. We have seen significant advancements in more traditional or classic AAV gene therapies that are allowing these to be safer and more efficacious. And we’re seeing an expansion of cell-based gene therapies through an ever-expanding portfolio of indications that are reached by CAR Ts, primarily in cancer, but in an expanding outlook for the use of CAR Ts outside of cancer as well. So, I am hopeful that attendees come away with a renewed energy and vigor for the development of satellite gene therapies.

LeMieux: Is there anything specific planned at the meeting to touch on the concerns of the challenges that the scientific community is facing right now—with funding or other barriers?

Barrett: We are very excited to have Katherine Szarama, PhD—who was recently named acting director of FDA’s Center for Biologics Evaluation and Research (CBER)—participating in a fireside chat, addressing regulatory uncertainties. [Szarama replaced Vinay Prasad, MD, MPH, on May 1st.]

We have two other fireside chats focused on regulation, as well. The three fireside chats will offer attendees an opportunity to learn a little more, ask some questions, and hear from some of the individuals in those sessions specifically.

But I think that people will also see, more broadly, the ongoing work that ASGCT is doing to continue to create a partnership and a positive working relationship with the FDA to support those regulatory concerns.

LeMieux: What are you most looking forward to?

Barrett: I think I said this last year, but it really is one of my favorite components of the annual meeting. Every year, I look forward to taking some time to watch the exhibit hall being built. When the rope drops and people enter the exhibit hall for that very first reception, the hall is in pristine condition. And one of my favorite parts is watching it get to that pristine condition because it is just so exciting to see everything being built and come to a head, to have the whole field enter all at one space, and to be able to see an industry live and in person. Because so much of what we do is at our computer screens—and what we read about, hear about, or listen to people talk about. But when you actually see the field of gene and cell therapy on display, it is really exciting and satisfying.

Lastly, I will add that I’m looking forward to eating too much clam chowder while in Boston (chuckling).

The post ASGCT CEO David Barrett Previews the Upcoming Conference in Boston appeared first on GEN – Genetic Engineering and Biotechnology News.

Barriers and Facilitators in the Implementation of the Systematic Medical Appraisal, Referral, and Treatment (SMART) Mental Health Digital Intervention in Rural India: Mixed Methods Process Evaluation Study

<strong>Background:</strong> An estimated 150 million people have mental health care needs in India, but only 15% are able to access care. Depression and anxiety contribute to a large proportion of mental morbidity. The Systematic Medical Appraisal, Referral, and Treatment (SMART) Mental Health trial used a mobile-based clinical decision support system for primary care doctors and community health workers (CHWs) to identify and treat people at risk of depression, anxiety disorders, and self-harm. A community-based antistigma campaign was also delivered. The intervention led to improved remission rates for depression and anxiety and lower stigma scores. <strong>Objective:</strong> A process evaluation assessed (1) implementation fidelity, barriers, and facilitators; (2) perceptions of doctors and CHWs on the use of SMART Mental Health; and (3) the causal pathways that led to trial outcomes. <strong>Methods:</strong> A mixed methods evaluation combining backend program data and qualitative data was conducted. A total of 38 focus group discussions and 37 key informant interviews were conducted with primary doctors, CHWs, government officials, local community leaders, and research project staff. The data were coded and analyzed using a framework analysis approach based on the UK Medical Research Council guidance on process evaluations and the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. <strong>Results:</strong> The intervention had high implementation fidelity. Across clusters, the median proportion of participants with at least 1 CHW follow-up was 98% (IQR 96.6%-100%). The referral rate for a psychiatrist was low (224/1697, 13.2%), and only 23.6% (53/224) of those referred visited the psychiatrist. The median exposure to antistigma audiovisual content was 84% (IQR 65.7%-95.9%). At the community level, key implementation barriers included cultural inhibitions in seeking mental health care and the unavailability of patients due to competing demands. Proximity and tight social connections between CHWs and their communities were important facilitators in seeking medical help. Doctor and CHW training, mentoring, and feedback provided by program staff were important facilitators to support the use of the digital health components by the health workforce. <strong>Conclusions:</strong> A complex intervention that included both community-based antistigma and clinical digital health interventions achieved high implementation fidelity. Key areas to consider for maintenance of such interventions include (1) the need for sustained community-based strategies to address stigma and other cultural barriers; (2) health workforce strengthening policies, including supportive supervision for CHWs and doctors to increase capability in the use of mental health digital health tools; and (3) strategies to improve access to specialist care for those with more complex care needs. <strong>Trial Registration:</strong> Clinical Trial Registry India CTRI/2018/08/015355; https://tinyurl.com/5r63suxp

Immune Mapping Links Sex-Specific Genetics to Autoimmune Disease

The largest study to date to examine immune differences between sexes at single-cell resolution has identified over 1,000 genetic switches that operate in distinct ways when comparing immune cells from men and women. Published today in The American Journal of Human Genetics, these findings could explain why women are much more likely to be affected by autoimmune conditions than men. 

“Our findings show that the immune system needs to be studied with sex in mind,” says Seyhan Yazar, PhD, group leader of the precision immunology program at the Garvan Institute of Medical Research in Australia. “Even though we know men’s and women’s immune systems differ, many studies still overlook these differences, which can limit how well we understand disease, and in turn bias treatment options.”

Yazar’s team analyzed single-cell RNA sequencing data from over 1.25 million circulating immune cells from nearly 1,000 healthy individuals who participated in the OneK1K cohort. This Australian research program maps how individual immune cells respond to disease and pathogens to determine why some individuals respond to treatment but others don’t. 

Results revealed distinct genetic and cellular profiles between both sexes. While men were found to have a higher proportion of monocytes, women showed higher levels of B cells and regulatory T cells. In men, genetic activity seemed to focus on basic cellular maintenance processes, but in women genetic activity heavily skewed towards the activation of inflammatory pathways. 

“While this highly reactive immune profile gives females an advantage in fighting viral infections, it comes with a biological trade-off: a greater predisposition to autoimmune diseases,” says Sara Ballouz, PhD, senior lecturer at the University of New South Wales (UNSW). “On the other hand, male immune cells are less primed for inflammation, making men generally more susceptible to infections and non-reproductive cancers.”

Interestingly, most of the genetic switches found to be active in individuals of one sex but not the other were not found to be located in sex chromosomes. More than 1,000 sex-specific genetic switches were identified on autosomes, with many of them being directly linked to autoimmune conditions. 

“This is the first time we have shown that these differences occur at the genetic control level, providing a new layer of insight into human immunity,” Ballouz says. “Having shown that female-biased genes are heavily enriched in inflammatory pathways, we now have another biological rationale for why the immune system can more easily mistakenly attack the body’s own tissues in women.”

The analysis found female-specific genetic variants that affected the expression of two genes linked to systemic lupus erythematosus (SLE), an autoimmune condition that is nine times more likely to affect women than men. Although conditions like SLE are multifactorial, uncovering the contribution of genetic variants to their development is an important step forward towards better understanding disease susceptibility between sexes. 

“Our findings add strong evidence that female and male autoimmune diseases may not be the same, and the way we should treat them may not necessarily be the same,” says Yazar. “Currently, clinicians rely on a one-size-fits-all management approach for most autoimmune diseases—a more inclusive approach is needed.”

Currently, autoimmune conditions are often treated with broad immunosuppressants that reduce the activity of the entire immune system. Research is striving to move towards treatments that more precisely target each person’s unique needs, which is only possible through the identification of distinct genetic pathways driving autoimmune disease. 

“If we want to realize the potential of precision medicine, we have to understand these fundamental biological variables,” says Joseph E. Powell, PhD, director of the translational genomics program at the Garvan Institute. “Treatments need to be tailored not just to the disease, but to how a patient’s immune system operates at a baseline genetic level.”

The post Immune Mapping Links Sex-Specific Genetics to Autoimmune Disease appeared first on Inside Precision Medicine.

What’s next for IVF

MIT Technology Review’s What’s Next series looks across industries, trends, and technologies to give you a first look at the future. You can read the rest of them here.

Forty-eight years ago this July, Louise Joy Brown became the world’s first person born with the help of in vitro fertilization. Millions more IVF babies have entered the world since then. And that’s partly thanks to advances in technology that have made IVF safer and more effective.

But it’s still not perfect. The process can be slow, painful, and expensive—and that’s for the lucky people who are able to access it in the first place. And by at least one measure, IVF success rates have been declining in recent years.

Reproduction is complex, and there’s a lot that embryologists and gynecologists still don’t know and can’t control. They don’t know why many healthy-looking embryos don’t “stick” in the uterus, for example. They don’t always have an explanation for why their patients can’t get pregnant. And they can’t always account for vast differences in IVF success rates between individuals and between fertility clinics.

Scientists are working on all those questions and more. They’re wrestling with complex ethical questions about how new genetic tools will be used to analyze or even alter embryos. Meanwhile, technologies designed to standardize treatment, eliminate human error, boost success rates, and make IVF more accessible are already beginning to usher in a new era for assisted reproduction—one aided by AI and robots.

1. Helping embryos stick

Some of those technologies are being developed at the Carlos Simon Foundation in Valencia, Spain. When I visited in March, researchers gave me a tour of the labs and showed me a device that had been used to keep a human uterus alive outside the body for the first time.

While some members of the team dream of building artificial uteruses that might one day be able to carry a fetus to term, they first want to use such devices to learn more about implantation—the moment at which a fertilized egg makes contact with the lining of the uterus, burrows inside, and essentially “hatches,” triggering the start of a pregnancy.

Despite decades of advances in IVF, that process is still poorly understood. Even healthy-looking embryos stick no more than 40% to 60% of the time.

In IVF techniques used today, clinics can create early-stage embryos and wait until the uterus is deemed most receptive, but once they insert the embryo into the uterus, it’s on its own. Xavier Santamaria, senior clinical scientist at the Carlos Simon Foundation, and his colleagues are trialing a different approach. They’ve developed a device that, at the press of a button, injects the embryo into the uterine lining.

Scientists in Valencia showcase Transfer Direct.

JESS HAMZELOU / MITTR

In a demonstration I watched with a prototype, Santamaria picked up his speculum and turned to face the vaginal opening of his “patient,” which in this case was just a model of the real thing—a plastic bottom with labia, a vagina, a uterus, and ovaries, two short stumps representing what would normally be a pair of legs held in stirrups.

He hunched over and peered inside. “Embryo,” he called. His colleague Maria Pardo, an embryologist, passed him a thin needle containing a mouse embryo she had recently collected from a petri dish.

Santamaria’s device allows for the embryo-containing needle to be connected to a delivery tube. This tube also has a camera, a light, and a sensor that lets the doctor know when the needle reaches the uterine lining. Once it has been fed into the uterus, the gynecologist can see the inside of the organ and direct the tube to the lining.

Scientists in Valencia showcase Transfer Direct.

JESS HAMZELOU / MITTR

“When everything is ready, you just press the button,” Santamaria said as he activated it using a foot pedal, allowing the embryo to be injected. “There it goes.”

The team has just started a trial of the device; so far, fewer than 10 women have undergone the procedure, and none of those have become pregnant. But foundation director Carlos Simon is hopeful, noting that the inventors of IVF had to perform over 160 cycles before Louise Brown was born (between 1969 and 1978, that team performed 457 cycles in 250 people, resulting in only two live births). “The trial is ongoing,” he says.

2. Picking the “best” eggs, sperm, and embryos

One long-running challenge of IVF has been selection. Say you manage to collect 10 eggs from one partner and a decent-looking semen sample from the other. How do you choose which cells to use? The same question comes up once the resulting embryos have been cultured in a dish for a few days: Which should you transfer to the uterus?

Traditionally, these judgments have been made by eye. Embryologists literally pick the ones that look the best in terms of their shape or, in the case of sperm, how they move. But scientists have been working on alternatives. And over the last decade or so, many have turned to genetic testing to hint at which embryos have the best chances of creating a healthy baby.

The most commonly used test is called PGT-A, which stands for preimplantation genetic testing for aneuploidy. Aneuploidy essentially means having an “incorrect” number of chromosomes, and it is thought that embryos with such characteristics are more likely to be lost through miscarriage or potentially develop into babies with genetic conditions.

Once embryologists have created embryos in the lab, they can pinch off a few cells and test them for aneuploidies. The tests are especially beneficial for women over the age of 38, says Alan Penzias, a reproductive endocrinologist at Boston IVF. “You start to see an improvement: more babies and fewer miscarriages,” he says. The tests can shorten the time to pregnancy.

This type of genetic testing is possible thanks to multiple advances in technology—not just in genomics, but also in the ability to keep embryos alive in a dish for five to six days and the technique of freezing embryos while the cells undergo testing and thawing them once the results are in. And it has become hugely popular—some clinics do PGT-A tests on all their embryos.

But PGT-A won’t give you a perfect readout of a future baby’s genetics, says Sonia Gayete-Lafuente, a reproductive endocrinologist at the Center for Human Reproduction in New York City. And some of the abnormalities might be able to self-correct with time. Gayete-Lafuente and her colleagues have transferred some of those “abnormal” embryos into patients’ uteruses and seen them develop into perfectly healthy children, she says.

Other forms of PGT are even more controversial. PGT-P tests are designed to predict an embryo’s chances of developing complex traits that rely on multiple genes, including medical disorders but also physical characteristics like height or cognitive factors like IQ. These tests are new, and they are illegal in some countries, including the UK. But they are gaining ground in the US. Nucleus Genomics—a company that invites customers to “have [their] best baby”—promises to predict traits running the gamut from eye color and intelligence to left-handedness and risk of Alzheimer’s.

When I asked IVF practitioners how they might respond if a patient asked for this service, most dodged the question and told me there’s not enough evidence that any of these tests actually work. They also cautioned that selecting for one trait might inadvertently introduce new risks. None seemed especially keen on the idea of using genetic testing for anything other than preventing serious disease.

3. Speeding things up with AI

Some seemed more excited about the potential for AI. After all, AI tools are generally good at recognizing patterns. Many researchers have attempted to train tools to spot healthy sperm, eggs, and embryos.

And they’ve had some success. A team at Columbia University Medical Center in New York has developed a device that uses AI to examine semen samples from men who have only tiny numbers of healthy sperm. An embryologist might struggle to find a single healthy sperm in such a sample. But the Sperm Tracking and Recovery (STAR) system can analyze over a million microscope images in an hour. It has already been used to create healthy embryos. The team behind the work announced the first pregnancy resulting from the treatment in November last year.

Other teams are using AI tools to advance IVF in more dramatic ways. Around a decade ago, a reproductive endocrinologist named Alejandro Chavez-Badiola began developing an AI tool trained to rank embryos, another to rank eggs, and another to select sperm. He recalls being struck by a realization that these tools were “the brains that have the potential to drive robots in the future,” he says.

4. Using robots to standardize IVF

In the early 2020s, Chavez-Badiola and his colleagues decided to combine technologies and develop an automated system for IVF. In theory, a robotic system loaded up with AI tools could undertake most of the steps required in the IVF process: selecting the eggs and sperm, fertilizing eggs to create embryos, culturing those embryos in a dish, and selecting the “best” one for transfer. Such a system could “do everything in a standard way” without ever getting tired, he says.

Chavez-Badiola, who is now founder and chief medical officer at Conceivable, started building prototypes by motorizing regular IVF equipment and connecting it to computers. He and his colleagues started testing their system with animal cells before eventually moving on to human ones. “We were able to prove that integrating robots to automate different steps in IVF is doable,” he says.

The device is now being used to prepare sperm and eggs and create embryos. At least 19 children have been born following the automated IVF. It is early days, but Chavez-Badiola is hoping that future iterations of the machine could each process thousands of IVF cycles in a year, potentially making the procedure more affordable and accessible.

Many in the field are excited about the potential for automated devices like Conceivable’s. “This is all time saved for the embryologists,” says Laura Rienzi, a clinical embryologist and scientific director of the IVIRMA network of fertility centers in Italy. She also hopes it will help standardize IVF treatments. “Automation [will allow for] every patient to be treated in the same way in every single lab in the world,” she says.

5. Controversial edits are on the table

There’s a catch, however: All these technologies rely on the availability of at least some healthy sperm, eggs, and embryos at the outset. Embryologists and IVF patients have to work with what they’ve got. And sometimes, what they’ve got won’t result in a healthy baby. 

That’s why some scientists are proposing a controversial idea: using gene-editing technologies like CRISPR to tinker with the genome of an IVF embryo before it is implanted. The biophysicist He Jiankui infamously took this approach to create embryos that resulted in the births of three children in the late 2010s. He was widely condemned by the scientific community and ultimately spent three years in a Chinese prison

His former romantic partner Cathy Tie, who now leads startup Origin Genomics, is pursuing the technology as a potential way to prevent serious disease in children. At a recent event held at the Hastings Center for Bioethics, Tie made the case for using embryo editing to prevent diseases like cystic fibrosis, Huntington’s, and sickle-cell.

It won’t be straightforward from a technical, legal, or ethical perspective. Diseases that are known to be caused by single-gene mutations are good first candidates, but as the Center for Human Reproduction’s Gayete-Lafuente points out, most diseases are much more complicated than that. “I wish we could understand the genetic basis of every disease to be able to prevent it,” she says. So far, we can’t. Besides, most diseases can be influenced by our diets, behaviors, and environments as well as our genes.

As things stand, no one knows if editing a human embryo to eliminate the risk of one disease might increase a future child’s risk of some other disorder. And some scientists worry that such edits might be a slippery slope to genetic enhancement or eugenics.

Rienzi hopes that the technology might be developed in a safe way with regulatory oversight, and only for a specific list of diseases. “It has to be within a legal context,” she says. “But to me, it’s a dream.”

In the meantime, the field looks set to keep transforming with the development of new technologies that are already creating healthy babies. Watch this space. 

Noise, air pollution exposure and attention-deficit/hyperactivity disorder: a meta-analysis

ObjectiveThis meta-analysis evaluated the associations between noise exposure, air pollutants, and attention-deficit/hyperactivity disorder (ADHD) in children, aiming to inform future prevention strategies.MethodsStudies were systematically retrieved from CNKI, Wanfang, PubMed, Web of Science, Embase, and the Cochrane Library, covering publications from inception to November 2025. Heterogeneity was assessed using Cochran’s Q test and the I² statistic. Subgroup analyses, meta-regression, and sensitivity analyses were performed to evaluate the robustness of the findings.ResultsNoise exposure was associated with a small increase in ADHD risk (odds ratio [OR] = 1.03, 95% confidence interval [CI]: 1.01–1.05), with stronger associations for childhood exposure, whereas prenatal exposure showed no significant effect. Given the modest effect size, this finding should be interpreted cautiously. Particulate matter (PM2.5 and PM10) was significantly associated with ADHD in continuous-exposure models—PM2.5 (OR = 1.32, 95% CI: 1.16–1.50) and PM10 (OR = 1.47, 95% CI: 1.15–1.87). In dichotomous models, PM2.5 was not significant, while PM10 remained positively associated (OR = 1.58, 95% CI: 1.11–2.26). Elevated nitrogen dioxide (NO2) exposure was also associated with a modest increase in ADHD risk (OR = 1.11, 95% CI: 1.02–1.20), whereas nitrogen oxides (NOx), ozone (O3), and sulfur dioxide (SO2) did not show significant associations.ConclusionsNoise and several air pollutants (PM2.5, PM10, and NO2) were significantly associated with increased ADHD risk, particularly during childhood exposure. Other pollutants, including O3 and SO2, did not demonstrate significant effects. These findings suggest that environmental noise and several air pollutants may be associated with ADHD; however, some observed associations, particularly for noise and NO2, were modest in magnitude and should be interpreted cautiously. These results reflect observational associations rather than evidence of a strong or causal effect, while the evidence for some pollutants remains limited or inconclusive. Further research is needed to clarify pollutant-specific associations and the role of exposure timing.Systematic Review Registrationhttps://www.crd.york.ac.uk/PROSPERO/view/CRD42024593274, identifier CRD42024593274; https://www.crd.york.ac.uk/PROSPERO/view/CRD42025632899, identifier CRD42025632899.

Mayo Clinic’s REDMOD AI Doubles Early Detection Sensitivity in Pancreatic Cancer

Pancreatic ductal adenocarcinoma (PDAC) remains one of the deadliest malignancies, with five-year survival rates below 15% and more than 85% of patients diagnosed only after the disease has metastasized. The absence of reliable early detection strategies is a primary barrier to improving outcomes. Conventional imaging, including standard abdominal CT scans, typically fails to identify PDAC during its preclinical, “visually occult” stage, when curative intervention is still possible.

To address this detection gap, a team of researchers at Mayo Clinic, led by radiologist and nuclear medicine specialist Ajit Goenka, MD, has developed and validated a radiomics-based artificial intelligence model called REDMOD (Radiomics-based Early Detection Model), which can detect subtle imaging signatures of PDAC before tumors are visible. By analyzing quantitative texture and structural features embedded within routine CT scans, REDMOD identifies early biological changes associated with carcinogenesis. In a multi-institutional validation study reflecting real-world clinical conditions, the model detected 73% of prediagnostic cancers at a median lead time of approximately 16 months—nearly doubling the sensitivity of radiologists manually reviewing the same scans. Notably, detection rates were even higher more than two years prior to diagnosis, pointing toward REDMOD’s potential for make much earlier interventions possible.

REDMOD’s automated pipeline integrates advanced radiomic feature engineering, including wavelet-based analysis, and an ensemble classification approach trained to handle the low-prevalence nature of early detection. Its longitudinal stability and consistent performance across diverse imaging systems could help spur its eventual clinical adoption.

Importantly, REDMOD is designed to operate on CT scans already acquired in routine care, particularly in high-risk populations such as individuals with new-onset diabetes. This raises the possibility of embedding AI-driven risk assessment directly into existing clinical workflows, enabling opportunistic screening without additional imaging burden. If validated prospectively, such as in the ongoing AI-PACED trial, REDMOD could shift the paradigm from late-stage diagnosis to proactive detection, potentially increasing the proportion of patients eligible for curative treatment and improving survival in this otherwise lethal disease.

Inside Precision Medicine recently interviewed Goenka to provide an in-depth view of the development of REDMOD, its detection capabilities, and its potential for providing early signals of the development of PDAC.

IPM: Can you walk through how REDMOD was developed, from the initial concept to a fully automated system, and what key technical breakthroughs enabled it to detect pancreatic cancer before tumors are visible?

Goenka: The origin of REDMOD traces back to a question we asked several years ago: if pancreatic cancer is almost always lethal because we find it too late, is there information already sitting in routine computed tomography (CT) scans that we are failing to extract? We published a proof-of-concept in Gastroenterology in 2022 showing that radiomic features from the pancreas could distinguish prediagnostic CTs from controls with high accuracy. But that first-generation model had real limitations. It relied on manual pancreas segmentation, which is labor-intensive and introduces variability. It was tested at a 1:1 case-to-control ratio, which does not reflect the rarity of pancreatic cancer in any realistic screening scenario. And it used a standard classifier without mechanisms to handle severe class imbalance.

REDMOD was built to systematically address each of those barriers. The first breakthrough was automating the front end of the pipeline. We developed and validated a fully automated volumetric pancreas segmentation model based on the three-dimensional (3D) nnU-Net architecture, published separately, which removes the human bottleneck entirely. That made the system scalable; you can run it on thousands of scans without a radiologist drawing a single contour.

The second breakthrough was in feature engineering. We extracted 968 quantitative radiomic features from each segmented pancreas, then applied multi-scale image filtering using wavelet transforms and Laplacian-of-Gaussian (LoG) filters. The wavelet decomposition breaks the image into eight directional sub-bands at different spatial frequencies, allowing the model to detect textural patterns at scales that the human eye cannot resolve. We then used the Minimum Redundancy Maximum Relevance (mRMR) algorithm to distill those 968 features down to 40 that carried the most predictive information. What emerged was striking: 90% of the selected features were filter-derived, meaning the signal lives in the texture of the tissue, not in anything visible on the standard grayscale image.

The third breakthrough was the ensemble classifier. Rather than relying on a single algorithm, REDMOD combines logistic regression, random forest, and extreme gradient boosting (XGBoost) through a soft-voting mechanism. Each algorithm processes the same 40 features; their probabilistic outputs are averaged to produce the final classification. This architecture achieved the highest sensitivity among all configurations we tested, 73%, which matters enormously in a disease where missing a case is effectively a death sentence. The entire system was trained using Synthetic Minority Over-sampling Technique (SMOTE) to handle the class imbalance inherent in early detection, and validated on an independent test set with a roughly 7:1 control-to-case ratio that approximates real-world prevalence in high-risk cohorts.

The fourth breakthrough, and one that distinguishes REDMOD from models that produce a simple binary output, is the pliability of the operating threshold. REDMOD generates a continuous probability score from zero to one. We used the Youden Index to define a statistically optimized default threshold (0.41), but this threshold can be adjusted to match different clinical objectives without retraining the model. In a non-invasive triage setting, the threshold can be lowered to maximize sensitivity, catching as many cancers as possible even at the cost of more false positives. When the clinical pathway moves toward invasive procedures such as biopsy, the threshold can be raised to prioritize specificity and precision, reducing the risk of subjecting healthy patients to unnecessary procedures. This tunability means that a single trained model can serve multiple roles across the clinical cascade, from initial risk stratification through confirmatory workup.

IPM: The model relies heavily on radiomic features, particularly wavelet-filtered textures. What do these features capture biologically, and why are they better suited to detecting early pancreatic cancer than conventional imaging markers?

Goenka: Conventional imaging markers for pancreatic cancer, such as a visible mass, ductal dilation, or vascular involvement, are late manifestations. By the time you see them, the disease has typically been present for years. What we needed was a way to detect the biological processes that precede mass formation.

Radiomic texture features quantify the spatial relationships between voxels, which are the three-dimensional equivalent of pixels. They measure how intensity values co-occur, how they cluster, and how uniform or heterogeneous the tissue appears at different scales. Specifically, features derived from the Gray-Level Co-occurrence Matrix (GLCM) measure local patterns of intensity variation; Gray-Level Size Zone Matrix (GLSZM) features capture the distribution of connected regions of similar intensity; and Gray-Level Dependence Matrix (GLDM) features quantify how dependent each voxel’s value is on its neighbors. These are mathematical descriptions of tissue microarchitecture.

The wavelet filtering is what makes this work in the prediagnostic setting. A wavelet transform decomposes the image into sub-bands that isolate different spatial frequencies and directions. This allows the model to detect textural disruptions across multiple scales: fine-grained changes that might reflect early stromal remodeling or desmoplastic reaction, and coarser patterns that could correspond to alterations in parenchymal organization. When we performed ablation studies, models built from filtered features alone matched the full REDMOD performance (area under the receiver operating characteristic curve [AUC] of 0.82), while models restricted to unfiltered features dropped to 0.74. That 8-point difference was statistically significant and tells us that the prediagnostic signal is fundamentally a multi-scale textural phenomenon.

Biologically, this aligns with what we know about early pancreatic carcinogenesis. Before a mass forms, the tumor microenvironment undergoes extracellular matrix remodeling, fibrotic changes, and shifts in cellular density that alter tissue texture at microscopic scales. These changes are invisible to a radiologist reading the scan on a monitor, but they leave a quantitative fingerprint in the image data. That fingerprint is what REDMOD reads.

IPM: How did you assemble the training dataset, and why was it important to simulate a low-prevalence, real-world screening environment?

Goenka: Assembling the dataset was one of the most labor-intensive aspects of this work, because prediagnostic CT scans are inherently rare. These are scans obtained for unrelated clinical reasons in patients who were later diagnosed with pancreatic cancer, but at the time of the scan, the pancreas appeared entirely normal on radiology review. We identified 219 such patients across the Mayo Clinic enterprise, with scans obtained three to 36 months before histopathologic diagnosis. Each was verified by expert radiologists to confirm the absence of any discernible pancreatic abnormality.

The control cohort comprised 1,243 patients whose CT scans showed a normal pancreas and who remained cancer-free for at least three years of follow-up. That three-year washout period was essential; without it, you risk contaminating the control group with patients who had undetected cancer at the time of their scan.

We then split the full cohort into 969 training cases and 493 test cases, with the test set held completely independent. The resulting control-to-case ratio of approximately 7:1 was a deliberate design choice. Most artificial intelligence (AI) studies in this space have used balanced 1:1 ratios, which inflate performance metrics and do not reflect the reality of early detection. In any high-risk cohort you would screen clinically, for example patients with new-onset diabetes and elevated Enriching New-Onset Diabetes for Pancreatic Cancer (ENDPAC) scores, pancreatic cancer prevalence is roughly 3-4%. If you train and test your model at 1:1, you get numbers that look strong in a paper but collapse when deployed in a real population. We wanted REDMOD’s reported performance to approximate what a clinician would actually experience.

IPM: You validated the model across multiple institutions, imaging systems, and external datasets. What were the biggest challenges in ensuring consistent performance across such heterogeneous data?

Goenka: The central challenge is that CT scans are not standardized. Different hospitals use different scanners from different manufacturers, different acquisition protocols, different reconstruction algorithms, and different contrast timing. All of these affect the pixel-level values that radiomic features depend on. A model that works well on data from one scanner can fail on data from another.

We addressed this at multiple levels. First, our prediagnostic cohort was inherently heterogeneous. 71% of the prediagnostic CTs in the test set were acquired at external institutions, not at Mayo Clinic. These scans came from a range of scanners (Siemens, GE, Toshiba, Philips) and clinical settings. Second, we validated specificity on two independent external cohorts: a multi-institutional dataset drawn from the Mayo Clinic enterprise across multiple campuses, and the National Institutes of Health Pancreas CT (NIH-PCT) dataset, which is a publicly available benchmark that uses entirely different acquisition parameters. REDMOD achieved 87.5% specificity on the NIH-PCT dataset, data the model had never encountered and that was acquired under conditions completely outside our control.

Third, we performed a longitudinal test-retest analysis. For patients with serial CT scans, we assessed whether REDMOD produced consistent predictions across time points. The concordance rate was 90-92%, meaning the model’s output was stable despite natural variations in patient hydration, contrast timing, and physiologic state between scans. That kind of temporal stability is essential for any tool used in a surveillance context, where you need to trust that a change in the model’s output reflects a real biological change, not scanner noise.

IPM: How do you see REDMOD being integrated into existing clinical workflows, for example in evaluating incidental CT scans or screening high-risk groups like patients with new-onset diabetes?

Goenka: The population where this has the most immediate clinical relevance is individuals with glycemically-defined new-onset diabetes (gNOD) and an ENDPAC score of three or higher. This is a well-characterized high-risk group with a 3-4% short-term risk of developing pancreatic cancer, roughly 20 times the general population rate. Many of these patients already receive CT scans for other clinical indications. The question is not whether to scan them; the question is whether we are extracting all the information those scans already contain. We were not. REDMOD changes that.

The workflow we envision is not a population-wide screening program. It is a targeted, risk-stratified approach. An electronic medical record (EMR)-based algorithm identifies patients who meet gNOD and ENDPAC criteria. When those patients undergo a CT scan, either for clinical reasons or as part of a structured surveillance protocol, REDMOD runs in the background, analyzes the pancreas automatically, and generates a risk score. If the score exceeds a defined threshold, it triggers a clinical pathway: the referring physician is notified, and the patient enters a structured workup that could include enhanced imaging, molecular imaging with fibroblast activation protein (FAP)-targeted positron emission tomography (PET) radiotracers, or closer follow-up.

REDMOD does not replace the radiologist. The radiologist reads the scan according to standard practice and generates their clinical report independently. REDMOD operates as a parallel, complementary layer, a second opinion from a system that reads data the human eye cannot access. The physician integrates both sources of information to make clinical decisions.

This is precisely the model we are testing in the AI-PACED (Artificial Intelligence for Pancreatic Cancer Early Detection) prospective clinical trial at Mayo Clinic. In this trial, all CT scans are interpreted by non-study radiologists who are blinded to the study objectives, and their reports enter the patient’s medical record as part of routine clinical care. Independently, the AI analysis is performed on de-identified data on secure research servers. A strict firewall separates the two: AI-generated outputs are not integrated into the EMR, are not communicated to the clinical team, and are not used to guide diagnosis or treatment. This dual-layered design ensures that participants receive the benefit of structured clinical surveillance while allowing a blinded, independent evaluation of the AI’s performance.

IPM: With the AI-PACED prospective trial underway, what are the key questions you still need to answer about clinical utility, false positives, and patient outcomes before this technology can become part of standard care?

Goenka: There are several questions that retrospective data alone cannot answer, and AI-PACED is designed to address them.

The first is lead-time advantage. We know REDMOD detects prediagnostic signal at a median of 475 days before clinical diagnosis in retrospective data. The question is whether that lead time translates into an actual shift in diagnostic timing in a prospective setting, that is, whether patients in a structured AI-augmented surveillance protocol receive their diagnosis earlier, and at a more resectable stage, compared to patients receiving symptom-driven standard care. The trial’s primary endpoint is the time-to-diagnosis from gNOD onset, compared between the interventional and observational cohorts using Kaplan-Meier survival analysis and Cox proportional hazards modeling.

The second is false positives. In the retrospective validation, REDMOD had an 81% specificity, which means approximately 19% of healthy patients received a positive flag. In a low-prevalence screening population, even a modest false positive rate generates a meaningful number of patients who undergo additional workup for a cancer they do not have. AI-PACED will quantify the downstream diagnostic burden, including additional imaging studies, biopsies, and the psychological impact, so we can make an honest assessment of the risk-benefit tradeoff. It is worth noting that REDMOD’s precision of 36.2% at its default operating point already exceeds the 3% precision threshold recommended by the United Kingdom’s National Institute for Health and Care Excellence (NICE) at the first step of cancer referral, and established screening programs for lung and breast cancer accept similar tradeoffs at their initial triage steps.

The third is adherence. This is a surveillance protocol in asymptomatic people. They feel fine. Asking them to return for serial CT scans and blood draws over 12 months requires trust, and that trust has to be earned through transparency about what we know and what we do not know. AI-PACED will measure recruitment yield from EMR-identified high-risk individuals, retention rates across the imaging and biobanking protocol, and the practical challenges of integrating AI into existing radiology workflows without disrupting standard care.

The fourth, and perhaps most important for the long term, is whether earlier detection actually changes outcomes. Stage shift, moving a patient from stage IV to stage I or II, is necessary but not sufficient. We need evidence that patients diagnosed through AI-augmented surveillance live longer, have access to curative surgical resection, and experience better quality of life. That is the bar this technology must clear, and it is the bar we intend to hold ourselves to.

The ongoing phase of AI-PACED is a feasibility study. It is designed to generate the operational, logistical, and preliminary clinical data needed to justify and design a fully powered, multi-institutional trial. In addition, we are running in silico clinical trials and cost-effectiveness analyses. We are building the evidence base one layer at a time, because the stakes, for patients and for the credibility of AI in clinical medicine, are too high to cut corners.

 

The post Mayo Clinic’s REDMOD AI Doubles Early Detection Sensitivity in Pancreatic Cancer appeared first on Inside Precision Medicine.

The Download: seafloor science and military chatbots

This is today’s edition of The Download, our weekday newsletter that provides a daily dose of what’s going on in the world of technology.

Inexpensive seafloor-hopping submersibles could stoke deep-sea science—and mining

Last week, two oblong neon submersibles started to descend nearly 6,000 meters into the Pacific Ocean. Throughout the rest of May, they will map the seafloor in search of critical mineral deposits. 

If all goes well, the vehicles, built by Orpheus Ocean, could help scientists probe the vastly understudied deep sea—and the resources it holds—at a fraction of the cost of existing systems.

But the same submersibles are also attracting deep-sea mining companies, raising concerns about environmental impacts. Find out why they’re drawing so much attention.

—Hannah Richter

The new war room: 10 Things That Matter in AI Right Now 

A new kind of system has entered the war room: conversational AI tools that commanders turn to not just for analysis, but for advice. 

One US defense official told MIT Technology Review that personnel might give these advice engines a list of potential targets to help decide which to strike first. China is commissioning similar tools too.

But as the systems gain traction, they’re also sparking concerns about AI-generated errors, a lack of transparency, and Big Tech gaining undue influence over what information gets seen. 

Here’s how these AI advice engines could impact the battlefield.

—James O’Donnell

The new war room is one of the 10 Things That Matter in AI Right Now, our list of the big ideas, trends, and advances in the field that are driving progress today—and will shape what’s possible tomorrow.

MIT Technology Review Narrated: is fake grass a bad idea? The AstroTurf wars are far from over. 

In 2001, Americans installed just over 7 million square meters of synthetic turf. By 2024, that number was 79 million square meters—enough to carpet all of Manhattan and then some. The increase worries folks who study microplastics and environmental pollution.  

While the plastic-making industry insists that synthetic fields are safe if properly installed, lots of researchers think that isn’t so. 

—Douglas Main 

This is our latest story to be turned into an MIT Technology Review Narrated podcast, which we publish each week on Spotify and Apple Podcasts. Just navigate to MIT Technology Review Narrated on either platform, and follow us to get all our new content as it’s released.

The must-reads

I’ve combed the internet to find you today’s most fun/important/scary/fascinating stories about technology.

1 Elon Musk pushed OpenAI to go commercial, its president has testified
Greg Brockman said Musk tried to turn it into a for-profit company years ago. (NYT $)
+ Musk allegedly wanted full control so he could raise $80 billion to colonize Mars. (Reuters $)
+ The Tesla CEO claims he intended for OpenAI to remain a non-profit. (BBC)
+ Here’s what happened in week one of Musk v. Altman. (MIT Technology Review)

2 Google and Meta are building AI agents to rival OpenClaw
Google’s Gemini agent will take actions on the users’ behalf. (Business Insider)
+ Meta’s will be powered by its Muse Spark AI model. (FT $)
+ Hustlers are cashing in on China’s OpenClaw AI craze. (MIT Technology Review)

3 Anthropic will spend $200 billion on Google’s cloud and chips
The investment will be spread across five years. (The Information $)
+ It’s part of a broader AI compute war. (Axios

4 DeepSeek is nearing a $45 billion valuation
A state-backed “Big Fund” will lead a new investment round in the company. (FT $)
+ Beijing is pushing to build alternatives to Nvidia and OpenAI. (Bloomberg $)
+ Here’s why DeepSeek’s new model matters. (MIT Technology Review)

5 Anthropic is launching AI agents for banks and financial firms
The 10 tools cover a broad mix of financial services tasks. (WSJ $)
+ They’re part of a push to win over Wall Street. (Bloomberg $)

6 Apple will pay $250 million to settle an AI lawsuit
It was accused of misleading iPhone buyers about Apple Intelligence. (BBC)
+ Some iPhone owners are eligible to receive up to $95. (NYT $)

7 Cheap laptops and phones may be disappearing because of AI demand
 Competition for memory chips is driving up gadget prices worldwide. (The Guardian)

8 Google DeepMind workers in the UK have voted to unionize
As a result of Google’s work with the Pentagon. (Wired $)

9 Pennsylvania is suing Character.AI over chatbots posing as doctors
Investigators say the bots claimed to hold medical licenses. (NPR)
+ How well do AI health tools work? (MIT Technology Review)

10 Scientists created a “living” plastic that destroys itself on command
It could help to eliminate microplastics. (Gizmodo)

Quote of the day

“I want AI to benefit humanity, not to facilitate a genocide.” 

—An anonymous Google DeepMind worker tells the Guardian that Google’s work with the Israel Defense Forces had motivated their vote to unionize.

One More Thing

a tiger shark seen underwater with a camera on its flank

COURTESY OF BENEATH THE WAVES


How tracking animal movement may save the planet

For decades, wildlife researchers have dreamed of building an “Internet of Animals”—a big-data system that monitors and analyzes animal behavior to help us understand the planet. Advances in sensors, AI, and satellite technology are now bringing that vision to reality.

Scientists want the system to track 100,000 sensor-tagged animals. They believe it could reveal how species respond to climate change and ecosystem loss—and even predict environmental disasters. Read the full story on how their idea could save our planet.

—Matthew Ponsford

We can still have nice things

A place for comfort, fun and distraction to brighten up your day. (Got any ideas? Drop me a line.)

+ Master the art of fried chicken with this definitive chef’s guide.
+ Find out why some birds hop and others walk in this breakdown of avian lifestyles.
+ This vintage Hollywood map shows how California’s landscape stood in for everything from the Nile to the Alps.
+ Here’s a fascinating look at the “Flatbed” airplane that was surprisingly efficient on paper but never left the hangar.