The Download: the tech reshaping IVF and the rise of balcony solar

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.

What’s next for IVF

IVF has brought millions of babies into the world over the last four decades. But the process can still be slow, painful, and expensive—and far from guaranteed to work. Now, a wave of new technologies aims to change that. 

Researchers are using AI to identify promising sperm and embryos, developing robotic systems that could automate parts of the IVF process, and even exploring controversial genetic editing techniques designed to prevent inherited disease.

The technologies could make IVF more effective and accessible. But they’re also raising difficult ethical questions about how far reproductive medicine should go.

Find out what’s next for IVF.

—Jessica Hamzelou

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

The balcony solar boom is coming to the US

Dozens of US states are considering legislation to allow people to install plug-in solar systems, often called balcony solar. These small arrays require little to no setup and could help cut emissions and power bills.

Proponents say the systems could make solar power more accessible, but some experts caution that there are safety concerns. 

Read the full story on balcony solar’s potentially massive impact in the US.

—Casey Crownhart

This article is from The Spark, our weekly climate newsletter. Sign up to receive it in your inbox every Wednesday.

Resistance: 10 Things That Matter in AI Right Now

Resistance against AI’s proliferation is growing. People from all walks of life are speaking out against rising electricity bills from data centers, disappearing jobs, chatbots’ impact on teen mental health, the military’s use of AI, and copyright infringement—among other concerns. 

People want to have a say in how the technology transforms their future. And they’re starting to create small cracks in AI labs’ vision for the future. Find out how.

—Michelle Kim

Resistance is on our list of the 10 Things That Matter in AI Right Now, MIT Technology Review’s guide to what’s really worth your attention in the buzzy world of AI. 

The must-reads

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

1 After years of insults, Anthropic and SpaceX have teamed up
Anthropic will tap SpaceX’s GPUs to meet surging demand. (Axios)
+ While SpaceX gets a marquee customer for its AI ambitions. (Wired $)
+ Anthropic says the deal will double Claude Code’s rate limits. (Ars Technica)
+It’s also exploring building compute capacity in space. (CNBC)
+ Musk previously called Anthropic “evil” and “misanthropic.” (Gizmodo)

2 Ex-OpenAI leaders say Sam Altman sowed “chaos” and distrust
Former CTO Mira Murati said she couldn’t trust his words. (The Verge)
+ He also bypassed OpenAI’s safety board before a model release. (Gizmodo)
+ And pitted leaders against one another. (Forbes)
+ But Elon Musk still tried to recruit Altman to lead a Tesla AI lab. (FT $)
+ Here’s why Musk and Altman are in court. (MIT Technology Review)

3 China’s humanoid robots are fueling its next export boom
Morgan Stanley says Beijing has taken an early lead in the sector. (Bloomberg $)
+ Gig workers are training humanoids at home. (MIT Technology Review)

4 SpaceX’s IPO plans will give Elon Musk “virtually unchecked” authority
And erode typical shareholder protections. (Reuters $)
+ Activists and pension funds are pushing back against the IPO. (Wired $)
+ While SpaceX is shifting focus from Falcon 9 to Starship. (Ars Technica)

5 Google DeepMind will use the MMORPG Eve Online for AI model testing
It’s also bought a stake in the game’s maker. (Ars Technica)
+ DeepMind also recently built a new video-game-playing agent. (MIT Technology Review)

6 The US risks isolating its automakers by banning a Chinese EV standard
It’s prohibiting software that’s dominating global EV markets. (Rest of World)

7 Elon Musk’s proposed Texas chip factory could cost $119 billion
It would manufacture chips for Tesla, SpaceX, and xAI. (CNBC)
+ Future AI chips could be built on glass. (MIT Technology Review)

8 Why the “attention-span crisis” is misunderstood
Technology may be exhausting attention rather than shortening it. (Atlantic $)

9 Scientists are getting closer to explaining what causes lightning
New tools are revealing unexpected physics inside thunderstorms. (Quanta)

10 Kids have found an age verification loophole: fake mustaches
Resourceful children are foiling blocks on adult websites. (TechCrunch)

Quote of the day

“My concern was about Sam saying one thing to one person and completely the opposite to another person.”

—Mira Murati, the former CTO of OpenAI, testifies ‌in court that CEO Sam Altman was deceptive, Reuters reports.

One More Thing

ALAMY


A brief, weird history of brainwashing

During the Cold War, the US prepared for a psychic war with the Soviet Union and China by spending millions of dollars on research into manipulating the human brain. 

The science never exactly panned out, but residual beliefs fostered by this bizarre conflict continue to play a role in ideological and scientific debates to this day. And now, new technologies are altering how we think about mind control. 

This is how the race for mind control changed America forever.

—Annalee Newitz

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.)

+ Listen to the 10 bird songs of spring in this lovely compilation of American species.
+ Good Samaritans saved a 29-foot whale that had wandered too far into a river.
+ Explore the intersection of human emotion and machine learning in this look at AI’s influence on art.
+ Break down the walls between streaming services and manage all your digital music in one place with this app.

PMAT enhances sexual dimorphism of fear behaviors and facilitates female mice’s generalized contextual fear extinction

Enhanced signaling of dopamine and/or serotonin during highly arousing situations can be reduced in part by monoamine transporters, such as plasma membrane monoamine transporter (PMAT, Slc29a4). An absence of selective pharmacological inhibitors means genetically modified mice constitutively deficient in PMAT remain the best tool for studying PMAT’s organism-level functional effects. Fear conditioning is a high arousal process. Generalization of fear is evolutionarily advantageous, whereby information learned from one experience is applied to other new but similar encounters. Pathological fear generalization, in contrast, is a core feature of most anxiety disorders. Given our previous findings indicating PMAT function reduces male mice’s context fear and enhances extinction of female mice’s cued fear, we hypothesized PMAT would similarly reduce generalization (i.e., enhance discrimination) of context and cued fear in male and female mice, respectively. Our context and cued fear conditioning experiments in adult PMAT wildtype (+/+) and heterozygous (+/−) male and female mice partially supported our hypotheses. We discovered PMAT facilitates extinction of contextually generalized fear, plus subsequent extinction of context-specific fear, selectively in females. Moreover, when specific fear cues or contexts were temporally presented before cues or contexts that were similar enough to make generalization possible, PMAT enhanced biological sex differences. Growing evidence reports common PMAT polymorphisms elicit measurable effects when PMAT function is reduced. Thus, we suspect future experiments may reveal positive associations between PMAT polymorphisms and risk for anxiety disorder symptoms, particularly in people assigned female at birth. Inclusion of these genetic variations in pharmacogenomic analyses may prove therapeutically beneficial.

[Articles] Who receives psychiatry-focused pharmacogenomic testing, and is it associated with prescribing patterns and acute care utilisation in depression? Real-world evidence from a large health system

In routine clinical practice, PGx testing is preferentially used in youth and adults with clinically complex histories and is associated with shifts in antidepressant prescribing patterns. Exploratory findings suggest hypothesis-generating signals of reduced psychiatric ED utilisation among patients with higher psychiatric complexity, which requires further confirmation. Observed racial disparities highlight the need for earlier and more equitable implementation. Prospective studies incorporating symptom-level and safety outcomes are needed to determine whether PGx-guided prescribing translates into meaningful clinical benefit.

Bayer to Acquire Perfuse for up to $2.45B, Seeing Ophthalmology Opportunity

Bayer has agreed to acquire Perfuse Therapeutics for up to $2.45 billion, the companies said, in a deal designed to broaden the buyer’s ophthalmology pipeline with Perfuse’s sole pipeline drug and two clinical phase programs for eye disorders.

Perfuse’s PER-001 is a small molecule endothelin receptor antagonist being developed for the treatment of ophthalmic diseases. Two of PER-001’s four programs are in Phase II development: One designed to treat open-angle glaucoma by improving the visual field for patients, and the other designed to treat diabetic retinopathy (DR) by improving contrast sensitivity and reducing ischemia in patients with the disorder.

Last year, Perfuse announced positive results from two Phase II clinical trials evaluating PER-001.

One was a Phase IIa trial (NCT05822245) assessing PER-001 in glaucoma, which showed that six months after a single intravitreal administration of PER-00, added to existing standard-of-care intraocular pressure (IOP)-reducing therapies, 22.2% of low-dose and 37.5% of high-dose patients experienced ≥7 decibel (dB) improvement in a pre-defined retina region of minimal five test points compared to 0% in control in six months.

The improvement was 8–14x better than the natural history of disease (2.7%) with currently available treatments, Perfuse said at the time.

In the other Phase IIa trial (NCT06003751), which focused on DR, patients showed a mean of +0.9 dB improvement in low luminance contrast sensitivity in the high-dose group and +0.65 dB in the low-dose group across multiple frequencies measured at week 20. In contrast, a mean of -2.1 dB worsening occurred in the control group over the same period.

The low luminance, low contrast visual acuity was better by a mean difference of 5.5 and 5.1 letters from baseline in low- and high-dose groups compared to control measured at week 20, Perfuse said at the time.

PER-001 is also in preclinical development for dry age-related macular degeneration (AMD)/geographic atrophy, as well as for retinal vein occlusion.

“We are excited by the work of the team at Perfuse Therapeutics and encouraged by the potential of PER-001,” Juergen Eckhardt, MD, head of business development and licensing at Bayer Pharmaceuticals, said in a statement. “With this acquisition, we are complementing our expertise in ophthalmology and our pipeline, reinforcing our commitment to developing urgently needed therapies for patients.”

Looking beyond Eylea®

Bayer’s ophthalmology pipeline has long been dominated by the blockbuster drug Eylea® (aflibercept), co-marketed with Regeneron Pharmaceuticals and initially approved in 2011. However, Eylea is close to losing exclusivity for key U.S. patents: According to Regeneron’s Form 10-K annual report for 2024, patents for Eylea expire between 2027 and 2039, starting with four formulation patents expiring on June 14, 2027. Patents for the higher-dose version, Eylea HD®, expire between 2027 and 2032, starting with two formulation patents expiring on June 14, 2027.

Last year, Eylea and Eylea HD saw their sales slip in the mid-teens, generating a total combined $8.04 billion in revenue, consisting of $4.385 billion in U.S. net sales for Regeneron and €3.11 billion in ex-U.S. sales for Bayer (about $3.655 billion today, up from the $3.506 billion reported in January).

During the first quarter of this year, Regeneron reported $941 million in U.S. sales, down 10% from a year ago; Bayer plans to report Q1 sales on May 12.

PER-001 is an intravitreal bio-erodible implant administered into the vitreous cavity of the eye using a single-use, 25-gauge applicator and designed to provide a sustained release of the drug, allowing for a convenient dosing regimen, according to Perfuse and Bayer.

Bayer has agreed to pay $300 million upfront for Perfuse, which is headquartered in San Francisco with R&D facilities in Durham, NC. The remaining up to $2.15 billion in deal value hinges on Bayer achieving development, regulatory, and commercial milestones.

The acquisition deal is subject to approval by Perfuse shareholders and antitrust clearances.

“I’m incredibly proud of what the Perfuse team has accomplished and deeply thankful to all our investors and collaborators,” stated Sevgi Gurkan, MD, Perfuse’s founder and CEO. “Bayer’s vision aligns closely with ours, and they have the scale and global resources to unlock the full potential of PER-001 to change the trajectory of human blindness. We are very excited to see our mission continue with even greater momentum.”

The post Bayer to Acquire Perfuse for up to $2.45B, Seeing Ophthalmology Opportunity appeared first on GEN – Genetic Engineering and Biotechnology News.

Opportunities and Challenges of Generative AI in Postgraduate Health Professions Education Assessments From Educator and Learner Perspectives: Qualitative Study

Background: The application of artificial intelligence (AI) is increasingly valuable as a tool and assistant in many areas of clinical and academic medicine. Generative AI (GenAI) creates new content used by large language models, which can generate language that strongly resembles or even improves on that of humans. Learners and educators in many areas of education are using GenAI for essays and assessments, raising issues regarding learning and assessment. GenAI is also raising new concerns in health professions education (HPE), an area of health professions training that sometimes has different aims and assessment methods compared to its clinical counterparts. HPE needs to assess levels of knowledge and understanding of pedagogy, and the use of GenAI presents challenges to its current assessments, which are predominantly written. Objective: The study aimed to investigate educators’ and learners’ perspectives on the opportunities and challenges presented by GenAI in postgraduate HPE assessments. It particularly focused on perspectives of how GenAI may influence the future of assessment and essay-based assessments in HPE. Methods: Informed by a constructivist paradigm, a qualitative approach was adopted, undertaking 8 semistructured interviews conducted via Microsoft Teams. Purposive sampling ensured a mixture of educators and learners in current HPE courses from a range of health care professions. Data were thematically analyzed. Results: There was no difference between educator and learner perspectives. Four themes were identified: AI is here, students are at a disservice if we do not embrace it; AI as an opportunity to rethink HPE assessments; AI is a “gray area”; and AI is fallible. Conclusions: The findings present AI as an external catalyst, highlighting the current internal desire for assessment change within HPE. It offers opportunities for creative, authentic assessments that reflect real-life academic and clinical practice, aiming to develop competent future HPE educators and keep courses relevant. These findings contribute to the debate around the future potential and development of AI in HPE assessments.
<img src="https://jmir-production.s3.us-east-2.amazonaws.com/thumbs/0c77d2e8765c4b20533fdb19cba1beac" />

Trump administration’s drug strategy is at odds with recent actions on funding, policy

The White House’s new strategy for addressing the nation’s drug crisis calls for a number of consensus public health measures: the overdose-reversal medication naloxone, medication-assisted treatment, and test strips used to detect fentanyl or other drug supply adulterants. 

But the May 4 document appears to run counter to many of the Trump administration’s latest drug policy actions. In particular, it comes just days after the administration issued new restrictions on using federal dollars to distribute test strips and warned against the use of medication-assisted treatment unless accompanied by other services, like counseling. 

Read the rest…

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.

Early Glucagon Elevation Linked to MASLD in Type 2 Diabetes

Researchers at the German Diabetes Centre have found that glucagon, a hormone that is considered to be a counterbalance to insulin, is elevated early in type 2 diabetes (T2D) and closely linked to the development of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). The findings, published in the journal Diabetes Care, indicate that dysregulation of glucagon occurs soon after diagnosis of type 2 diabetes and is associated with liver fat accumulation, information that could prompt a shift in the understanding of how MASLD progresses and suggesting new ways to treat it.

“Our findings highlight that type 2 diabetes should not be viewed solely from the perspective of insulin action. The liver and the regulation of glucagon play a special role in metabolism,” said senior author Michael Roden, MD, scientific director of the German Diabetes Centre.

The aim of the research was to address unresolved questions about the activity of glucagon in early type 2 diabetes and how it may influence the development of fatty liver disease (MASLD). While insulin resistance is central to diabetes research, glucagon is also known to contribute to elevated blood glucose by stimulating hepatic glucose production. MASLD is also common in people with type 2 diabetes, yet the interaction between liver fat and glucagon regulation is not well understood.

To investigate glucagon’s role in this regard, the researchers analyzed 50 adults with newly diagnosed type 2 diabetes and 50 people with normal glucose tolerance matched for age, sex, and body mass index. Participants underwent mixed-meal tolerance tests to assess glucagon and metabolites, hyperinsulinemic-euglycemic clamps to measure insulin sensitivity, and imaging using magnetic resonance spectroscopy and MRI to quantify hepatic lipid content and visceral fat.

The resulting data indicated that those people with newly diagnosed type 2 diabetes had significantly higher liver fat and elevated glucagon levels both when fasting and after meals.

“Individuals with T2D had an ∼65% higher HLC as well as higher fasting and postprandial glucagonemia (∼30% and ∼75%) than those with NGT,” the research noted. The presence of MASLD, rather than diabetes itself, was associated with higher fasting glucagon levels. Elevated glucagon levels after a meal were specifically linked to liver fat content in those people with type 2 diabetes.

These associations were independent of insulin sensitivity and visceral adipose tissue. “Hyperglucagonemia in the face of higher HLC in early T2D is not due to differences in insulin sensitivity or glucagonotropic metabolites but could suggest hepatic glucagon resistance,” the researchers wrote.

The study also addressed the role of amino acids and nonesterified fatty acids (NEFAs), which previous research has suggested serve as mediators of glucagon secretion. But the current research did not show this to be the case. “This study demonstrates that 1) fasting glucagon concentrations are elevated and tightly associated with MASLD already in newly diagnosed T2D and 2) increased postprandial glucagon levels are positively linked to HLC only in early T2D, but not NGT… but 3) neither amino acids nor NEFAs mediate this hepatopancreatic relationship,” the researchers wrote.

These findings could boost current development of glucagon-based drugs, including dual- and triple-agonists targeting incretin and glucagon receptors, which are already being studied for the treatment of MASLD. The study implicates that altered glucagon physiology in type 2 diabetes may influence how patients respond to drugs, and differences in glucagon signaling may help explain why some therapies appear less effective in individuals with diabetes compared to those without.

While this study was cross-sectional and does establish causality, the researchers pointed to the consistent associations across multiple metabolic measurements as evidence to support further investigation. Additional work could determine whether hepatic glucagon resistance can be directly measured and targeted. Future research will also focus on finding out whether modifying glucagon signaling can alter the progression of MASLD and type 2 diabetes, and how new therapies in development can be personalized for patients with different metabolic profiles.

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At-Home Blood Test Screens for Early Dementia

A simple finger-prick blood test at home combined with online cognitive tests can reveal signs of Alzheimer’s disease, providing a convenient way to screen for early dementia.

The postal blood test, outlined in Nature Communications, is used to measure levels of two blood biomarkers linked with cognitive function: phosphorylated tau at amino acid 217 (p-tau217) and Glial Fibrillary Acidic Protein (GFAP).

It could provide a way to screen for dementia at home and act as a triage resource to identify those at risk earlier and tailor treatments more effectively, particularly in remote or unsupervised settings.

“This work raises the potential for screening people for their risk without the need for clinic visits or complex clinical assessments,” said lead researcher Anne Corbett, PhD, from the University of Exeter.

“It would ensure the people at highest risk could be prioritized for monitoring and diagnosis, unlocking the best support and treatment for those that need it most.”

While blood biomarkers are increasingly being used to diagnose Alzheimer’s disease, scalable tools are needed to reach the 99% of individuals with early cognitive impairment who are not seen in specialist healthcare services.

In an attempt to develop these further, Corbett and team conducted a study involving 174 people, of whom 146 had normal cognition and 28 had dementia.

All were participants in the PROTECT study, a larger investigation of more than 30,000 adults that aims to understand how healthy brains age and why people develop dementia.

Blood samples were collected at home using self-administered capillary blood tests, which were sent for p-tau 217 and GFAP lab testing. Venous blood samples were also available for 40 patients.

p-tau217 has previously been highly accurate at detecting Alzheimer’s disease pathology and is approved by U.S. regulators for symptomatic patients undergoing investigation for cognitive complaints.

GFAP is associated with broader cognitive decline and has been shown to be associated with Aβ deposition and progression of mild cognitive impairment to Alzheimer’s disease.

Brain performance tests were found to correlate with levels of both proteins, with p-tau217 showing the strongest association.

Capillary p-tau217 was significantly higher in people with dementia compared to those without and was significantly associated with cognitive performance and function.

A combination of an 85% specificity threshold for capillary p-tau217 85% and episodic memory performance one standard deviation (SD) below benchmarked norms identified 9% of participants who were at potentially high risk, and who also showed significantly higher impairment in cognition and function.

Importantly, this threshold for impairment of episodic memory indicated a much milder level of impairment than the 1.5 SD change required to identify people with mild cognitive impairment, revealing its potential ability to spot signs at a preclinical stage.

Unexpectedly, even though ptau217 and GFAP both identified individuals with cognitive impairment, there was only a modest overlap in individuals who were positive for both GFAP and p-tau217, with GFAP identifying a different group of at-risk individuals. GFAP biomarker appeared to be associated with vascular risk, unlike p-tau217.

Researcher Clive Ballard, MD, PhD, also at Exeter, said: “Our approach of combining our robust cognitive testing with measuring proteins via a postal blood test could provide a straightforward, efficient and cost-effective method to reach large numbers of people in the community who would not otherwise be prioritized for the next steps of diagnosis or support and to optimize the clinical pathway to enable early detection of those at highest risk.”

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