The FDA has confirmed that it will not use the final days of the Obama administration to enhance oversight of certain laboratory tests.
The agency spent the last two years developing a policy for so-called “Laboratory Developed Tests” or LDTs, which are tests that are only used by a single laboratory to diagnose specific diseases.
Around 5,000 LDTs on the market are viewed as “moderate” or “high-risk” and would have required review under the FDA’s proposal.
The FDA already evaluates the vast majority of laboratory tests that are manufactured commercially and used at multiple labs nationwide.
The loophole has allowed LDTs to proliferate in an era of personalized medicine. As manufacturers compete in the $10 billion market, FDA has issued warnings about hyped-up accuracy claims and serious risks.
Unlike commercial lab tests, the FDA does not validate accuracy claims on LDTs. That is why it is always a good idea to get a second test. False results could lead to patients being treated for diseases they do not have, or dying from diseases that went undetected.
Last year, the FDA released a report analyzing the effects of inaccurate results from 20 high-risk LDTs.
For example, approximately 20% of current HER-2 breast cancer gene testing may be inaccurate. When the test fails to detect HER-2, a sign of a more aggressive disease, women with breast cancer do not receive the optimal chemotherapy treatment, risking cancer recurrence and death.
Another example is prenatal testing. Some of the most popular LDTs screen for birth defects. While most claim to be 99% accurate, studies show that older women are more likely to have harmless variations in their DNA that can trigger false-positives for major chromosomal birth defects. Without a confirmation test, false readings may lead to unnecessary abortions or the birth of babies with birth defects.