Walk into almost any U.S. hospital today and you will find AI doing some of the important work of medicine: drafting clinical notes, flagging sepsis, screening imaging, conducting prior authorizations, and answering patient messages. Adoption is moving fast, and the benefits are real.
But there’s a problem. Most health systems are monitoring the safety and performance of these tools the same way they govern a new MRI scanner in 2010: a subcommittee, a checklist, a quarterly meeting, an approval or a rejection. The process could take six months or longer.
That approach was already strained for older digital tools. For AI, it is dangerously inadequate, and the responsibility for fixing it rests not with IT, but with senior leadership.
California may be known as the Golden State, but it may well be referred to as the Genome Editing state after this week’s announcement of an inter-state partnership. The University of California (UC), San Diego, and the Innovative Genomics Institute (IGI), founded by Nobel laureate and CRISPR gene editing co-discoverer Jennifer Doudna, announced a new partnership to jointly develop cutting-edge genomic tools for addressing large-scale challenges in health and the environment.
Doudna founded the IGI in 2015 with the aim of translating the success of gene editing in the lab into practical solutions for large societal problems. Initially formed as a partnership between UC Berkeley and UC San Francisco with a focus on using CRISPR in human health, the IGI expanded to include sustainable agriculture and climate change applications of genome editing, adding UC Davis as a partner. UC San Diego is joining as the IGI’s fourth UC partner campus, combining research strengths in environmental and marine science, engineering and computer science, and biomedical and life sciences to develop the next generation of genome-editing tools and applications.
“I’m thrilled that the IGI is now partnering with UC San Diego,” said Doudna. “The mission of the IGI is to develop solutions that can not only scale to meet the biggest challenges in health and climate, but to make solutions that are accessible to those who need them most. UC San Diego helps us expand that real-world impact.”
An artistic depiction of a jumbo phage infecting a bacterium. [Margot Riggi]
The relationship between UC San Diego and IGI research labs has been building over the past decade. For several years, the IGI has been collaborating with UC San Diego researchers Joe Pogliano, PhD, professor in the Department of Molecular Biology, and Kit Pogliano, PhD, dean and professor in the School of Biological Sciences, on applied microbiology projects. They have worked with UC Berkeley-based labs on developing new therapies focusing on “jumbo phage” for antibiotic-resistant bacterial infections as well as a novel defense strategy against viral infections.
In 2023, UC San Diego researchers were awarded $10 million by the Howard Hughes Medical Institute to explore the biomedical promise of jumbo phage as therapeutic agents. Also in 2023, the IGI received a $70 million gift through the Audacious Project to develop microbiome-editing tools and apply them to problems caused by microbes and microbiome imbalances, including livestock methane emissions and inflammatory diseases like asthma. Other areas of the effort focus on developing more efficient tools for genome editing across a wide breadth of microorganisms to expand the impact of this technology.
In the environmental arena, UC San Diego researchers have worked closely with UC Berkeley labs since 2018 to develop tools for combatting crop pests, managing disease-carrying mosquito populations, and developing safe protocols for environmental applications of genomic technologies.
“UC San Diego brings exceptional strengths across biological sciences, medicine, engineering, computation, environmental research, and ocean science that align powerfully with the IGI’s mission,” said Pogliano.
In addition to the current collaborations, IGI’s executive director Brad Ringeisen foresees multiple areas of synergy: “UC San Diego’s strengths in engineering, medical devices, environmental research, and the microbiome complement IGI’s current research areas, and allow us to expand our societal impact in new ways,” he said.
New joint projects of particular interest include interdisciplinary programs designed to bolster the climate resilience of our oceans and soils through innovative scalable solutions, and combining UC Berkeley’s biotechnology discovery engine with UC San Diego’s biomedical research and health system to improve the drug discovery pipeline for rapid translation across areas like antimicrobial resistance and neurodegenerative disease.
Medline (Nasdaq:MDLN) announced today that it plans to open a new distribution facility in Perris, California. The approximately 1-million-square-foot facility marks the latest expansion to the company’s distribution network, following a buildout in Texas earlier this year. Northfield, Illinois-based Medline says it adds capacity and operational flexibility to support healthcare providers across the state. The…
Health Secretary Robert F. Kennedy Jr. said the new actions — which come after previously announced Medicaid funding deferrals in those states — are part of the administration’s strategy to “stop the fraud before it happens” rather than claw back problematic spending after bad actors are prosecuted, as previous administrations had done.
Background: Depression carries the highest burden of mental health–related disability in the United States. Approximately 13% of military veterans report elevated rates of depression. Despite the availability of evidence-based treatments for depression, nearly 50% of veterans in need of mental health care remain untreated. Internet-based interventions show promise in reducing this gap; however, there are currently no standard self-guided internet-based interventions for depressive symptoms in veterans. Deprexis is one such intervention that leverages cognitive behavioral therapy to target depressive symptoms. Objective: This pilot study evaluated the feasibility, acceptability, and preliminary effectiveness of Deprexis, a fully self-guided internet-based intervention for depression, in US military veterans with mild to severe depressive symptoms. Methods: This open-label pilot trial recruited 19 veterans with mild to severe depression (mean age 55.5, SD 8.2 y; baseline Quick Inventory of Depressive Symptomatology—Self-Report [QIDS-SR]: mean 16.2, SD 4.1) for an 8-week course of Deprexis, with self-report assessments at baseline, posttreatment (8 wk), and follow-up (16 wk). Primary outcomes included depressive symptoms (QIDS-SR), functional disability (World Health Organization Disability Assessment Schedule 2.0), and symptom-related disability (Sheehan Disability Scale). Feasibility was assessed through recruitment and retention rates, and acceptability was measured using validated questionnaires (Credibility and Expectancy Questionnaire and Client Satisfaction Questionnaire). Multilevel models examined change over time, with effect sizes calculated using pooled SDs from unconditional models. Results: Recruitment and retention targets were met, with 15 out of 19 (79%) participants meeting the adherence criteria (ie, ≥60 min of active program use). Of these, 14 participants completed posttreatment questionnaires and were included in the completer analyses. The program received a positive acceptability rating: of the 18 participants who completed follow-up assessments, 78% (n=14) rated services as good or excellent and 72% (n=13) were satisfied with the amount of help received. No safety concerns were reported. Among completers (n=14), QIDS-SR scores decreased from baseline to posttreatment (estimate −2.22, SE 1.44; =.14; =−0.54, 95% CI −1.07 to 0.13) and follow-up (estimate −2.85, SE 1.19; =.02; =−0.70, 95% CI −1.21 to −0.08) with moderate-to-large effect sizes. Effect sizes were similar in the total sample. Functioning (World Health Organization Disability Assessment Schedule 2.0) improved among completers at follow-up (estimate −8.09, SE 3.80; =.045; =−0.41, 95% CI −0.96 to −0.05). Disability (Sheehan Disability Scale) did not significantly improve from baseline to posttreatment or follow-up. Conclusions: This pilot trial demonstrates that Deprexis is feasible and acceptable for veterans with mild to severe depression, with preliminary evidence of effectiveness for depressive symptoms. The delayed emergence of functional improvements and sustained gains at follow-up support the potential of this scalable intervention. The results provide a strong foundation for the ongoing randomized controlled trial. Trial Registration: ClinicalTrials.gov NCT06217198; https://clinicaltrials.gov/study/NCT06217198 International Registered Report Identifier (IRRID): RR2-10.2196/59119
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Researchers from Keio University School of Medicine and Keio University Regenerative Medicine Research Center in Japan transplanted neural stem/progenitor cells derived from induced pluripotent stem cells (iPSCs) into the injured spinal cords of four men with recent, complete cervical spinal cord injuries. The first-in-human Phase I study, published in Nature Medicine, primarily evaluated safety, following participants for up to four years after treatment.
Spinal cord injury affects more than 20 million people worldwide and often results in permanent paralysis because the adult spinal cord has only limited capacity to regenerate. Current treatments—including surgery and rehabilitation—can stabilize the injury and maximize remaining function but cannot rebuild the damaged neural circuits responsible for movement and sensation.
The transplanted cells were manufactured from clinical-grade iPSCs under strict quality controls before being differentiated into neural stem/progenitor cells. Approximately two million cells were injected directly into each patient’s spinal cord injury site two to four weeks after injury while patients received temporary immunosuppressive therapy to reduce the risk of rejection.
The trial met its primary objective. Researchers observed no tumor formation, abnormal cell growth, or other serious complications attributable to the transplanted cells during the initial 52-week study period or the subsequent long-term follow-up. Imaging studies likewise revealed no evidence of graft-related abnormalities, addressing one of the field’s greatest concerns regarding therapies derived from pluripotent stem cells.
Although safety was the principal endpoint, investigators also tracked neurological recovery. All four participants showed improvements in motor function, and two improved enough to advance from complete paralysis (American Spinal Injury Association Impairment Scale grade A) to grades C or D, indicating recovery of some voluntary movement below the injury level. Median motor scores improved by 13 points after one year, exceeding the recovery typically observed in a comparable historical patient registry, although the researchers caution that the small, uncontrolled study cannot establish that the stem cell treatment caused these gains.
The encouraging results build on years of preclinical research showing that transplanted neural stem cells can differentiate into neurons and supporting cells, promote remyelination, stimulate regrowth of damaged nerve fibers, and release molecules that support tissue repair. Animal studies have also suggested that the transplanted neurons can integrate into existing spinal cord circuits, although such integration cannot yet be directly confirmed in patients.
The investigators emphasize that many questions remain before the therapy could become a standard treatment. The study enrolled only four participants, lacked a placebo control, and included only men with recent cervical spinal cord injuries. Larger randomized clinical trials will be needed to determine whether the treatment consistently improves neurological recovery and to identify which patients are most likely to benefit. Researchers also plan to continue monitoring participants to assess the long-term safety of the transplanted cells.
Even with those caveats, the findings represent a significant advance for regenerative medicine. Rather than demonstrating a cure for paralysis, the study establishes that carefully manufactured iPSC-derived neural stem cells can be transplanted into the human spinal cord without the serious safety issues that have long challenged the field. That achievement provides a critical foundation for the next generation of clinical trials aimed at determining whether stem cell therapy can ultimately restore function after devastating spinal cord injuries.
10x Genomics says it is on track to build out a CLIA-certified laboratory set to open next year, part of the spatial and single-cell tools developer’s expansion into clinical diagnostics launched earlier this year.
The lab will open within 10x’s headquarters campus in Pleasanton, CA, 10x co-founder and CEO Serge Saxonov, PhD, told GEN.
Serge Saxonov, PhD, 10x Genomics co-founder and CEO
“This is one great benefit that we have from the fact that we’ve got all the infrastructure here, and that’s why we feel like we can really accelerate some of these kinds of applications: Because we have the space, we have the expertise with the technology, we have the people who really know all the ins and outs of it, and we can very quickly, validate, new assays, test them, refine them, optimize them,” Saxonov said. “We have been seeing that already, in the time that we have been standing up some of these pieces, how enabling it is to have it all under one roof at this stage.
“Building a CLIA lab is definitely not a trivial undertaking, but we’ve been making really great progress,” he added. “The team has been standing up these capabilities, and definitely on track for early next year. So, very much looking forward to that.”
The CLIA lab is a key component of 10x’s move into clinical diagnostics, announced in January. Traditionally focused on research tools for academic, government, and industry customers, 10x has moved this year to launch clinical collaborations with top-tier institutions—the most recent of which was announced last month with Cleveland Clinic.
The nonprofit multispecialty academic medical center is partnering with 10x in a multi-year collaboration aimed at advancing research in novel diagnostics for bladder cancer. Cleveland Clinic has agreed to contribute patient samples with appropriate phenotypes for analysis on 10x’s Flex Apex single cell sequencing and Xenium spatial biology platforms.
“They have great access to patients and the right kinds of clinical trials and therapies that are going through their system,” Saxonov said. “We are working together to run single-cell and spatial analyses on them, collaborating on those and correlating the biology that we learn from single cell and spatial with therapeutic outcomes.”
Bladder cancer biomarkers
10x and Cleveland Clinic aim to identify biomarkers that predict how bladder cancer patients will respond to emerging therapies, such as immunotherapies and antibody-drug conjugates (ADCs).
“Those biomarkers are definitionally known already, but the actual context of their expression isn’t really that well known in terms of being able to predict response,” Saxonov explained. “The question is, if you see their expression in the context of the cancer cells, or the tumor microenvironment, or the immune compartment, it will then also inform response to therapy. And there’s plenty of evidence from scientific literature that there’s a lot of signal there, a really, really powerful signal there. What hasn’t been done is run rigorous, well-powered, clinically, really carefully well-defined studies to measure and evaluate those kinds of biomarkers.”
Oncology is one of two therapeutic areas viewed as priorities for pursuing translational applications with an eye toward potential clinical diagnostics that address therapy selection and monitoring. The other area is autoimmune disease.
Saxonov asserted that 10x’s clinical push was unrelated to its established research business, which shrank last year as its traditional base of academic and government (A&G) customers reeled from cuts in research funding. The cut prompted 10x to announce plans to eliminate about 100 jobs—8% of its workforce—though the workforce appears to have only shrunk by 18 jobs or about 4% last year, from 491 full-time employees as of December 31, 2024, to 473 at the end of last year, according to the company’s form 10-K annual filings.
“We feel our research business gives us an awesome foundation to now invest in this future of clinical applications. It is a very, very much an enabling thing,” Saxonov said. “It gives us a great foundation from which to go forward. It was always our plan, always our mission, always the strategy of the company that over time, as we develop our technologies, we want most naturally to make them actually have a direct clinical impact.”
Several recent trends have combined to support clinical expansion, Saxonov said:
An increasing number of therapies whose effectiveness in patients, and in what combination, remains unknown to many doctors.
A growing body of single-cell spatial signals, such as gene and protein expression, mapped to the exact physical coordinates of individual cells within a tissue.
Increased maturing of single cell, spatial, and multiomics technologies, resulting in more data and higher quality insights that enable their use in the clinic.
‘A really nice position’
“Investments around workflow, investments around logistics, being able to work with distributed collected samples, and also being able to drive the costs down and scale up these technologies—all of that progress now puts us in a really nice position to lean into, first, generating clinical evidence for all these different, therapeutic areas, then taking the resulting information and deploying that in the context of diagnostic tests in the future,” Saxonov said.
“Independent of whatever might be happening in terms of the research market, which will fluctuate over time, is that several large-scale trends have been converging.”
Is 2026 shaping up as an up year or a down year for A&G? Saxonov said he’ll offer insights when 10x releases its second quarter earnings in August.
10x announced its clinical ambitions in January during the J.P. Morgan 44th Healthcare Conference in San Francisco. The company unveiled clinical collaborations with two Boston-based institutions, Brigham and Women’s Hospital and Dana-Farber Cancer Institute, as well as the New York-based Cancer Research Institute.
The Cancer Research Institute collaboration focuses on generating “very large, AI-ready” data sets for immunotherapy, Saxonov said, while the Dana-Farber and Brigham and Women’s partnerships center more, like the Cleveland Clinic alliance, on generating clinical evidence for future diagnostics applications. Patient flows have been established, and analysis is underway in the collaborations with both Boston institutions.
“At the appropriate time, we’ll be updating the world about what we’re learning,” Saxonov added.
The past week has brought us two similar ideas of masculinity, separated by 4,000 years. When Defense Secretary Pete Hegseth announced the initiation of testosterone screening in all U.S. servicemembers 30 and older under the title “The High T Department of War,” his vision was as clear as an IMAX projection of Odysseus: a warrior in his physical prime, lethal in battle, unquestionably ascendant in the home, anointed by god.
Both of these men, the classical hero and the optimized modern soldier, are fantasies. But I’m worried Hegseth’s vision is a tragedy in the making
Revvity reports that its Signals Software business is launching Signals for Startups, a new program designed to help emerging biotech companies adopt scalable informatics capabilities earlier in their growth journey.
Built for early-stage biotechs, the program combines access to Signals software with guided onboarding and best-practice configurations for smaller biotechs to help accelerate innovation, improve scientific productivity and shorten time-to-value, according to a company spokesperson.
Startup biotechs are often under pressure to move quickly with limited IT, informatics, and operational resources while managing increasingly complex discovery data. Signals for Startups addresses this challenge with a purpose-built, scalable Signals environment that helps teams focus on science while establishing a strong digital foundation from day one, explains Kevin Willoe, president of Revvity Signals Software, adding that out-of-the-box configurations for large and small molecules enable companies to accelerate adoption, standardize data, and enhance collaboration on a proven, scalable informatics infrastructure.
“Signals for Startups addresses a critical need for emerging biotech companies that want to move fast without creating data and workflow challenges that limit their ability to scale,” he continues. “By combining startup-friendly access with guided onboarding and scalable Signals workflows, we are helping early-stage teams build the digital foundation they need to advance discovery, support investor readiness and grow with confidence.”
Signals for Startups is expected to be available in the U.S., Europe, the Middle East, and Africa later this month.
Nabla, the Paris-based maker of ambient scribes used to automate clinical documentation, says it’s playing the long game. On Tuesday the company announced a new leader and reiterated its commitment to fundamentally new AI technology it believes can help it beat the competition.
The company, which last raised a $70 million Series B last summer, announced a new CEO, Brian Manning, who has served as chief revenue officer at care coordination software company PatientPing and its acquirer, Bamboo Health, before taking over as Bamboo’s president. The shift “marks the next phase of Nabla’s go-to-market strategy,” the company wrote in a press release.
“We really haven’t built our brand in the United States. We really haven’t accelerated our go-to-market in line with what others are doing. And as we look towards 2027, that’s something we’re absolutely going to be doing,” Manning said in an interview with STAT. Chief operating officer Delphine Groll said that 100% of the company’s revenue is from the U.S.
