Sep 22 2022 65 mins 4
The Chromogen Siblings are back to talk about the proposed VALID Act. Drs. Mike Arnold (@MArnold_PedPath), Andrew Bellizzi (@IHC_guy), and Sanam Loghavi (@sanamloghavi) speak with Dr. Emily Volk (@EEVMD) of the University of Louisville and President of the College of American Pathologists (CAP, @Pathologists), and Dr. Jonathan Myles (@JonathanMyles10) of the Cleveland Clinic and Chair of the Council on Government and Professional Affairs for the College of American Pathologists. The VALID act has both strong support and strong opposition from groups such as patient advocacy groups and professional organizations. We'll learn about how the proposed VALID Act could change the way laboratory developed testing is regulated, the role of CAP in shaping legislation, and why CAP is supportive of the current version of the VALID Act despite concerns.
Read more about the CAP position on the VALID Act: https://www.cap.org/advocacy/laboratory-oversight-and-regulation/laboratory-developed-test-oversight/laboratory-developed-test-oversight-faqs
And previous regulatory issues that have shaped the proposed VALID Act:
Ovisure letter from the FDA: https://www.fda.gov/medical-devices/ivd-regulatory-assistance/ovasuretm-manufacturer-letter
New York Times Article on Prenatal Testing: https://www.nytimes.com/2022/01/01/upshot/pregnancy-birth-genetic-testing.html
Featured public domain music: Alpha Hydrae, Won't see it comin'.
Featured public domain cover image: https://www.usgs.gov/media/images/us-capitol-building
