FDA Takes Steps to Regulate Lab Tests It Says Puts Patients “At Risk”

Genetic tests revealing potential risks of cancer or other diseases without regulatory oversight are among the targets of the agency's proposed review.< /p>

The Food and Drug Administration announced Friday that it is preparing to close what has been widely seen as a loophole allowing certain laboratory tests, such as those that determine profile of a tumor or the genetic health of a fetus. - to circumvent the review with virtually no tracking or oversight.

The agency has proposed a rule that would place the tests under its regulatory authority, requiring that laboratories that perform them perform provide test data. precision. Hundreds of tests on the market have little oversight and can mislead the public and patients who want to know if they have Lyme disease, Alzheimer's disease or will develop cancer.

The proliferation of these tests “leaves Americans vulnerable and forced to make important health care choices based on potentially faulty or inaccurate test results,” said Dr. Robert Califf of the F.D.A. commissioner, said during a press briefing on Friday.

Tests, including the first to detect Covid-19, are the subject of concern from the The agency for 30 years and have been a perennial – but essentially untouchable – target by lawmakers since former Senators Edward Kennedy and Barack Obama and as recently as this year.

Academic medical centers that include labs operating the tests opposed the changes, citing the importance of being agile in the face of a rapidly changing, pandemic-prone world.

Although renewed focus on the accuracy of tests may be unsettling for patients, they had little clue — or even from their doctors — as to whether the tests had been thoroughly vetted or received by the FDA . oversight, according to Jeff Allen, president of Friends of Cancer Research, a nonprofit organization funded in part by pharmaceutical companies.

“A rule like that "This comes to the forefront to be sure that each test meets reliable standards of accuracy — so there is no need to ask these questions," he said.

Mr. Allen said a hospital's pathology lab may know the origins of a test, but that information is rarely relayed to doctors and patients. He said his organization was concerned about the accuracy of tests administered to glean a tumor's genetic profile that led to decisions about treatment.

A New York Times investigation found that prenatal genetic screening tests were often flawed, with many false-positive results.

Academic researchers, doctors and the F.D.A. have also criticized other similar tests. These include tests intended to calculate a person's so-called genetic propensity to develop diabetes or become an elite athlete.

Doctors also expressed concerns about tests intended to predict diabetes. chances of developing Alzheimer's disease. In 2015, the F.D.A. released a report on 20 tests of concern, including one to detect ovarian cancer and another for Lyme disease. A long-standing concern about these tests is whether they have misled patients facing decisions about whether to abort a fetus with a possible genetic abnormality or whether to perform a mastectomy or surgery. hysterectomy based on cancer screening tests.

Additional FDA opponents. ...