U.S. News: Lab-Run Tests Face New Food and Drug Administration's (FDA) Regulation.

 U.S. biotech practical applications could become more difficult. 

"The Food and Drug Administration is moving to regulate more closely a widely used class of tests that labs run to detect cancer, measure cholesterol and look for other health issues, people familiar with the agency's deliberations said.

The agency is drafting a proposal to help ensure the tests work as intended and are accurate, according to the people. The people wouldn't provide the timing for releasing the proposal.

The activity comes after a bill in Congress to more tightly regulate the tests stalled. An agency proposal, however, is likely to face heavy opposition from the $10 billion-a-year industry that develops and runs the tests and has thwarted earlier regulatory pushes.

"If the regulations become too burdensome, this could limit a lab's ability to provide those tests," said Shannon Haymond, president of the American Association for Clinical Chemistry, which represents 8,000 lab professionals.

At issue are tests on blood, urine and other specimens that labs at academic medical centers and public companies develop and run on their own, rather than selling for others to use. Many Americans depend on the tests to learn if they have the flu or low levels of testosterone, or if a baby might be born with a developmental disorder, for example.

Mayo Clinic, Labcorp and Quest Diagnostics are among those offering the lab-developed tests.

During the pandemic, many people in the U.S. found out whether they had Covid-19 from lab-developed PCR tests regulated by the FDA.

Yet the agency hasn't usually regulated the tests, unlike traditional lab tests, FDA-cleared machines or kits that companies sell nationwide, prompting concerns that people could be making important health decisions based on questionable test results.

The nonprofit Friends of Cancer Research has sponsored studies finding that results from different lab-developed cancer-related tests vary widely.

Some say the FDA doesn't have the legal authority to regulate lab-developed tests on its own, without legislation.

Quest referred questions to the American Clinical Laboratory Association.A representative said it is neutral on the legislation, but would prefer legislation to FDA issuing its own regulations. Labcorp didn't provide comment." [1]

1. U.S. News: Lab-Run Tests Face New FDA Regulation. Whyte, Liz Essley. 
Wall Street Journal, Eastern edition; New York, N.Y. [New York, N.Y]. 09 June 2023: A.3.