FDA wants to regulate thousands of lab tests that have long skirted oversight

abcnews.go.com:

The Food and Drug Administration says it plans to begin regulating laboratory-based medical tests

WASHINGTON — The Food and Drug Administration on Friday laid out a proposal to begin regulating laboratory medical tests, a multibillion-dollar industry that the agency says poses a growing risk to patients because of potentially inaccurate results.

The proposed rule would end decades of regulatory ambiguity and formally bring thousands of tests performed in large laboratories under FDA oversight. FDA Commissioner Robert Califf said the change will help ensure tests used to diagnose cancer, heart disease and many other conditions are safe, accurate and reliable.

“A growing number of clinical diagnostic tests are being offered as laboratory-developed tests without assurance that they work," Califf said in a statement. He added that the agency has long worried that many tests offered by laboratories are not as accurate or reliable as those that undergo FDA review.

Here's a look at the history and background of the testing issue:

Most Americans are familiar with medical tests like those used to screen for COVID-19, strep throat and other health conditions. Those tests are developed by a handful of large manufacturers that undergo FDA review before selling their test kits to hospitals, doctors offices or pharmacies.

The tests targeted by the FDA's latest action are developed and used by high-tech laboratories, including those at academic medical centers and companies such as Quest Diagnostics. They include tests for complex diseases like cancer, as well as simpler conditions like high cholesterol and sexually transmitted infections.

In the 1970s and '80s, most lab-based tests were “lower risk, small volume” products used mostly