PATH News Network Daily Edition

FDA Issues New Guidance on Cancer Clinical Trial Eligibility Criteria

• College of American Pathologists

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Nick Lanyi

The FDA's new guidance on cancer clinical trial eligibility, a new grant for residents interested in informatics, and the latest development in 3D imaging for pathology. These stories and more coming up next. This is Path News Network Daily Edition from the College of American Pathologists. I'm Nick Lanyi. It's Friday, July 31st. The FDA this week issued its final guidance on laboratory values for cancer clinical trial eligibility criteria. While not binding, the FDA's guidance helps providers and labs set eligibility criteria for when patients can participate in trials, such as minimum white blood cell counts. The FDA argues that eligibility criteria are sometimes more restrictive than necessary. Fewer than 5% of cancer patients currently undergoing treatment are enrolled in clinical trials, despite over 70% expressing a willingness to participate. Among the top takeaways from the final guidance, the FDA says that laboratory value-based eligibility criteria should be only as restrictive as necessary to mitigate clinical risks, should be customized to the drug under investigation, and that demographic differences in laboratory test results and their implications across populations should be understood when setting eligibility criteria. If you're attending CAP 26 in Las Vegas this fall, kick off the weekend by attending License to Give, an interactive experience. This year's event has an espionage theme that promises you will officially become an agent of the CAP Foundation for the evening. You'll enjoy interactive challenges, uncovering hidden clues, entertainment, food and drink, and a raffle. Every ticket purchase directly supports See Test & Treat, the Foundation's initiative to expand cancer screening and treatment for underserved communities. Tickets are on sale at the CAP Foundation website, foundation.cap.org. Pathology residents interested in learning more about informatics can apply for a grant of up to $1,200 to attend next year's CAP Annual Meeting, September 2027 in Chicago. The grant will cover travel expenses to attend the meeting and participate in sessions focused on informatics, basically data collection, management, and analysis. The Informatics Travel Award is open to pathology residents only. It's intended to increase the specialty's knowledge about how informatics can improve clinical applications, standardized reporting and laboratory test utilization, electronic health records, workflow, and patient safety. The application period starts August 3rd. For more information, see the CAP Foundation website. And speaking of informatics, a new study is demonstrating advances in the field of 3D imaging for pathology. Most three-dimensional CT data is in grayscale, good for measuring density differences, but not for the all-important visualization of color contrasts that pathologists create via conventional histological stains. To create a virtual stain of CT data, researchers at the Paul Scherer Institute in Switzerland trained an AI model by showing it histological sections and their corresponding CT scans, enabling it to learn which microscopic patterns receive which staining. The AI model was then able to virtually stain the CT data with great precision in ways usable for diagnosis, the researcher said. They cautioned that the study was done in an academic setting using enormous amounts of data, and that clinical applications will take time to develop. It's just one example of the work being done in this field, including by CAP member Dr. Nick Reder, the co-founder and CEO of Alpenglow Technologies, a 3D imaging pathology startup based in Seattle. He spoke with us recently about the potential for 3D.

Dr. Nick Reder

We think this is an obvious next step in the evolution of digital pathology and that the slide is really just this intermediate placeholder, kind of like a horse-drawn carriage on the way to going to a cars. And so what we can do is digitize, we'll say, an entire prostate biopsy instead of just one slice. And so that can actually lead to detecting cancer that would have otherwise been missed or higher-grade cancer that would have been classified as lower grade. And it creates bigger and better data sets for these AI tools that predict outcomes or predict response to therapy. So, you know, we're - I'm biased, but I do think that it's a natural evolution in technology.

Nick Lanyi

That's all for today. See the show notes for more information on today's stories. And if you've got a story to share, write us at stories @ CAP.org. We'll be back Monday at 5 a.m. Eastern for another episode of the Daily Edition. I'm Nick Lanyi. Have a wonderful weekend.