leisure time
A group representing clinical labs across the country sued the Food and Drug Administration on Wednesday over the agency’s plan to actively regulate lab-developed tests.
The suit, filed in a Texas federal court by the American Clinical Laboratory Association and PCR lab HealthTrackRx, claims the FDA does not have the authority to scrutinize lab-developed tests. When the FDA finalized its test regulation plan last month, several experts said it was only a matter of time until someone in the lab industry sued.
advertisement
Tests made in labs have historically gone unregulated by the FDA, as the agency considered them low-risk when it started regulating medical devices in 1976. But the tests have since become more numerous and complex, and the regulatory gray area enabled unreliable tests to thrive and harm patients. Infamous examples include Theranos’ blood tests, as well as misleading prenatal genetic tests from a range of companies.
STAT+ Exclusive Story
Already have an account? Log in
This article is exclusive to STAT+ subscribers
Unlock this article — plus daily intelligence on Capitol Hill and the life sciences industry — by subscribing to STAT+.
Already have an account? Log in
Already have an account? Log in
Monthly
$39
Totals $468 per year
$39/month Get StartedTotals $468 per year
Starter
$30
for 3 months, then $39/month
$30 for 3 months Get StartedThen $39/month
Annual
$399
Save 15%
$399/year Get StartedSave 15%
11+ Users
Custom
Savings start at 25%!
Request A Quote Request A QuoteSavings start at 25%!
2-10 Users
$300
Annually per user
$300/year Get Started$300 Annually per user
View All Plans
Get unlimited access to award-winning journalism and exclusive events.
Subscribe Log InNext article： At least 13 dead in Texas as scorching temps continue
