FDA to start regulating lab-developed tests

July 31, 2014 by Matthew Perrone

(AP)—The Food and Drug Administration announced Thursday it will begin regulating laboratory-developed tests, a growing class of medical diagnostics that have never before been subject to federal oversight.

The agency says its proposal is designed to make sure that the tests used to diagnose cancer, heart disease and thousands of other conditions are safe, accurate and reliable.

"Inaccurate test results could cause patients to seek unnecessary treatment or delay and sometimes forgo treatment altogether," said FDA Commissioner Dr. Margaret Hamburg, on a call with reporters. "These devices need to be accurate and reliable."

In recent years scientists have documented laboratory-based tests that provided incorrect results for diagnosing conditions like autism, Lyme disease and antibiotic resistance.

Hamburg said the agency will introduce a proposal to regulate these tests within the next 60 days.

Regulation of laboratory-developed tests has been a subject of debate since at least the 1990s. Several federal advisory committees, including the Institute of Medicine, have recommended that the FDA exercise more authority over such testing. That's also been the position of diagnostic test manufacturers, who have long been subject to rigorous FDA reviews before they can launch new products. The industry has complained to Congress and the FDA that their products must compete with cheaper laboratory-developed tests that have not undergone federal testing.

FDA regulators estimate that about 2,000 laboratories in the U.S. market more than 11,000 medical tests. But the agency's proposal would not apply to routine laboratory tests or tests for rare diseases where there is no FDA-approved option. Instead regulators are focusing on those that pose a higher risk for patients. The agency wants to require premarket review of accuracy and reliability for tests that:

  • compete with FDA-approved, manufactured tests
  • perform the same function as high-risk medical devices
  • are used in screening blood

After the FDA introduces a draft proposal later this year, regulators will take comments and feedback from interested parties. The agency will then prepare final, binding regulations. Medical laboratories will not have to begin submitting their tests for review until one year after the final regulations have been in place, according to the agency.

The American Clinical Laboratory Association said in a statement it is urging the FDA to "exercise caution, and expressed concern that another layer of regulation could stifle diagnostic innovation."

Explore further: FDA reviews DNA-based colon cancer screening kits

Related Stories

FDA reviews DNA-based colon cancer screening kits

March 24, 2014
The Food and Drug Administration is weighing the benefits and risks of two experimental colon cancer screening tests which use DNA from a patient's stool to detect dangerous tumors and growths.

FDA panel narrowly backs DNA colon cancer test

March 26, 2014
A panel of Food and Drug Administration advisers has narrowly backed an experimental blood test that uses patients' DNA to help screen for colon cancer.

FDA advisers back Exact Sciences colon cancer test

March 27, 2014
A panel of Food and Drug Administration advisers has voted to endorse an experimental stool test that uses DNA to detect colon cancer and precancerous growths.

FDA approves A1c test for diabetes diagnosis

May 29, 2013
(HealthDay)—The U.S. Food and Drug Administration has just cleared a hemoglobin A1c assay to be marketed for the diagnosis of diabetes, according to a May 24 press release issued by the agency.

Putting the brakes on home genetic testing: Four questions with geneticist Scott Diehl

December 4, 2013
The Food and Drug Administration recently ordered an end to sales of the home genetic testing kit 23andMe. FDA medical experts said the kit's manufacturers had failed to prove their claim that the $99 test can help customers ...

Recommended for you

Data revealed under FOI shows benefits of multiple sclerosis drug currently blocked by regulators

August 17, 2017
A drug that is blocked by the EU regulatory system has now been found to improve the quality of life of people with multiple sclerosis (MS), according to a study by Queen Mary University of London (QMUL).

Opioids overused in migraine treatment, regardless of race, study finds

August 17, 2017
African-Americans are more likely to experience debilitating migraine headaches than whites, but a new study probing the issue found no evidence of racial disparities in treatment practices.

Finding better ways to reduce serious drug side effects

August 14, 2017
Many of the medicines we depend on to treat disease—and even to save our lives—pose potentially serious risks along with their benefits. Data from the U.S. Centers for Disease Control and Prevention indicate that about ...

Ultrasound-triggered liposomes for on-demand, local anesthesia

August 10, 2017
Researchers at Boston Children's Hospital have found a new way to non-invasively relieve pain at local sites in the body; such systems could one day improve pain management by replacing addictive opioids and short-lasting ...

Independent pharmacies and online coupons help patients save money on drugs

August 8, 2017
Uninsured patients or those with limited prescription drug coverage can save significant money by buying their drugs at independent pharmacies instead of big box, grocery or chain drug stores and by using discount coupons, ...

New study generates more accurate estimates of state opioid and heroin fatalities

August 7, 2017
Although opioid and heroin deaths have been rising dramatically in the U.S., the magnitude of the epidemic varies from state to state, as does the relative proportion of opioid vs heroin poisonings. Further complicating the ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.