Mohacsy's Safe Portfolio Member Forum

[Elroy Jetson]

This is long overdue. Many medical tests are hilariously inaccurate, Elizabeth Holmes . Theranos bad, with some test makers like Labcorp actually advising Doctors testing for pathogens or diseases to submit the same sample six different times in order to eliminate the bias built into their tests to avoid false positives. Sadly most existing lab tests will be grandfathered in.

"Only a small percentage of the population have any given disease or pathogen, so our tests are deliberately designed to be insensitive and report false negatives, in order to avoid reporting false positives in the large number of patients tested. If you have a clinical basis for assuming your patient has a condition for which they test negative, our lab recommends you presumptive treat your patient and disregard the test results." - Labcorp

FDA brings lab tests under federal oversight in bid to improve accuracy and safety

https://www.marketwatch.com/story/fda-brings-lab-tests-under-federal-oversight-in-bid-to-improve-accuracy-and-safety-36561112

Makers of medical tests that have long escaped government oversight will have about four years to show that their new offerings deliver accurate results, under a government rule vigorously opposed by the testing industry.

The regulation finalized Monday by the U.S. Food and Drug Administration will gradually phase in oversight of new tests developed by laboratories — a multibillion-dollar industry that regulators say poses growing risks to Americans. The goal is to ensure that new tests for cancer, heart disease, COVID-19, genetic conditions and many other illnesses are safe, accurate and reliable.

“The agency cannot stand by while Americans continue to rely on results from these tests without assurance that they work,” FDA Commissioner Robert Califf told reporters on a conference call.

In a significant move, the FDA decided that the tens of thousands of tests currently on the market will not have to undergo federal review. The agency said it will essentially grandfather those tests into approval to address concerns that the new rule “could lead to the widespread loss of access to beneficial” tests.

Under the government’s plan, most newly developed tests that pose a high risk — such as those for life-threatening diseases — will need to be FDA approved within three-and-a-half years. Lower-risk tests will have four years to obtain approval.

All lab tests — old and new — will be required to register with the agency and report problems or errors. Based on this information, FDA officials said they will be able to target problematic tests.

FDA officials have long voiced concerns about the accuracy of some tests, pointing to patients who have received inaccurate results for heart disease, Lyme disease and other conditions. Inaccurate tests can lead to patients getting an incorrect diagnosis, skipping treatments or receiving unnecessary medication or surgery.

More than a decade ago, the agency drafted tougher guidelines for the industry, but they were never finalized. For years, U.S. labs have successfully lobbied Congress and other federal institutions against tougher regulation.

The American Clinical Laboratory Association which represents affected test makers such as Quest Diagnostics and Labcorp said Monday it “has grave concerns about this rule as a matter of both policy and law. The rule will undermine innovation in new diagnostics.”