FDA wants to introduce regulations for thousands of laboratory tests. The inaccuracies in the results are perhaps what prompted the agency to initiate the action. This is going to be an impactful decision as it is going to impact an industry worth a dollar industry.
The new regulation would legally place thousands of tests conducted in significant laboratories under FDA supervision , putting an end to decades of regulatory uncertainty.
The FDA has long avoided regulation of laboratory-developed tests despite consistently asserting that it has the power to intervene. The need for regulation is not new. In fact, it dates back to the early 1990s.
“A growing number of clinical diagnostic tests are being offered as laboratory-developed tests without assurance that they work. the agency has long worried that many tests offered by laboratories are not as accurate or reliable as those that undergo FDA review. The change will help ensure tests used to diagnose cancer, heart disease, and many other conditions are safe, accurate, and reliable,” informs Robert Califf, Commissioner, FDA.
High-tech laboratories create and employ the tests that the FDA is targeting with its most recent move. They include screenings for complicated disorders like cancer and less complicated ones like high cholesterol and STDs.
A multibillion-dollar industry has formed around laboratory-made tests throughout time, with labs processing tens of thousands of blood, urine, and other samples from hospitals and clinics each week.
The negative impacts of this trend are evident. Many tests were less inaccurate.