The CAP Weighs in on CLIA

Nick Lanyi
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The CAP weighs in on potential changes to clinical laboratory testing, two upcoming webinars, and researchers ID the genetic makeup of prostate tumors. 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, September 11th. The CAP urged the federal government this week to take a balanced approach to updating CLIA rather than making significant changes. The CAP was responding to the Federal Health Agency's request for information about the rising use of AI in laboratories, cybersecurity issues, and several other topics. In the letter, the CAP said pathologists must continue to oversee interpretation of diagnostic tests, with AI assisting and augmenting the pathologist's work, but not providing a diagnosis or making decisions about patient care. The CAP also called for a practical approach to laboratory oversight that maintains flexibility given the diversity of clinical laboratory settings, including independent, reference, academic, hospital-based, and community labs. New regulations that impose a one-size-fits-all approach could create undue burdens and disrupt a system that currently works well. Among specific recommendations, the CAP said pre-analytic activities, such as producing stained slides, should continue to be exempt from CLIA regulations. The CAP also advised that the use of virtual technology to perform direct observation of lab workers for competency assessments should be allowed if state and local laws and regulations allow it. You can read the entire response in the CAP website's advocacy section under updates. The CAP Foundation is hosting a webinar next week on blood tests that use circulating tumor DNA to find ESR1 gene mutations in breast cancer patients. The ESR1 mutation is associated with resistance to standard drugs to treat breast cancer, so detecting it early can help inform more effective treatment options. The webinar is sponsored by AstraZeneca. The presenter will be Dr. M el Krystel-Whittemore, a molecular genetic pathologist and regional medical director for medical diagnostics at AstraZeneca. The one-hour session is scheduled for Wednesday, September 16th at 11 a.m. Central Time. Register at the CAP Foundation website. Also scheduled for next week is a CAP webinar on how to get involved with advocacy efforts. It's called Pathology Beyond the Microscope, Advocacy in Action, and the presenter will be Dr. Elizabeth Conner, a molecular genetic pathology fellow at Mass General Brigham in Boston. The webinar, scheduled for Tuesday, September 15th at 6 p.m. Central Time, will be especially focused on issues involving early career pathologists. Register at the Education section of the CAP website. And finally, prostate cancer is the fifth leading cause of cancer death among men. While known to have a genetic component, prostate cancer's causes have not been specified until now. In a study of 959 prostate patients published in Nature this week, researchers from the International Pan Prostate Cancer Group said they identified the specific mutations that cause most prostate cancers. Eight so-called integrated mutational footprints, or IMFs, account for 85% of primary prostate cancer genomes. And four of the IMFs were linked to more aggressive forms of prostate cancer that are more likely to metastasize. That discovery could lead to the use of biomarkers to help determine the appropriate treatment in individual patients. That's all for today. Check the show notes for more information on today's stories. And if you've got a story for us, write to us at stories @cap.org. We'll be back Tuesday at 5 a.m. Eastern with another episode of the Daily Edition. I'm Nick Lanyi. Have a wonderful weekend.