“According to the Centers for Disease Control and Prevention, 70% of health care decisions are based on clinical lab tests. The potential for the future is even greater, with early detection and better treatment guidance, and opportunities for new targeted therapies that will be guided by diagnostic markers.”
The stakes are high, as so many decisions are based on test results from labs and tests that have very little oversight and do not need to prove #accuracy.
“For tests that are manufactured by the lab that administers them, however, the agency has exercised “enforcement discretion,” owing to a prior dispute about whether these tests were a medical device subject to FDA’s oversight, or a service being delivered as a part of the practice of laboratory medicine. While it has generally been agreed for years that lab-developed tests are devices and therefore also subject to FDA’s regulation, the agency’s posture of enforcement discretion has left it without an efficient approach — and a clear mandate — to oversee most of these products.”
“The result is an obsolete and bifurcated approach that leaves #patients and #providers often overestimating the amount of oversight that’s been applied to tests that matter for increasingly important clinical decisions.”
Anyone that follows our posts is aware that Center for Genomic Interpretation favors the passing of the VALID Act. #Regulation in this space is essential when so much is at risk.
As this article outlines, “The modernizations offered in the VALID Act would also enable more oversight to move to the post-market setting when appropriate. Right now, all new tests are automatically deemed as Class III — posing a high potential risk if inaccurate — and are subject to FDA’s most stringent requirements for a Premarket Approval application unless they’re reclassified, which can be an arduous process for a new test to navigate. Under the proposed act, the FDA would have more flexibility to adjust its approach to regulation based on risk, and down-regulate lower risk tests to moderate- or low-risk categories.”
Even if VALID passes, the grandfathered labs and time for the lab industry to implement the new regulations will mean that patients will be negatively impacted by inaccurate #diagnostics for years to come. Some oversight sooner than later is essential to precision medicine truly being precise!
Read the full article HERE