FDA report detailing faulty lab tests adds to pressure for increased regulation of diagnostics

The FDA's drive to regulate the molecular diagnostics industry is gaining steam. It finally provided specific examples of problematic tests in a report to Congress. The agency has made several general statements about inaccurate diagnostics over the years without naming any specific tests or providers.

The report pointed to an unproven diagnostic for ovarian cancer that may have led to "unnecessary surgery to remove healthy ovaries," according to the New York Times. Another group of tests has been given to 150,000 people even though the genetic variant that it detects is not proven to be correlated with heart disease, resulting in improper treatment or dosing of cholesterol-lowering statins. And women have undergone unnecessary abortions due to inaccurate tests of the fetus.

Redwood City, CA's Genomic Health defended itself after being singled out in the report, telling the New York Times that "a wealth of evidence has supported use of our test to help guide chemotherapy treatment decisions in more than 500,000 breast cancer patients to date."

It appears the report's conclusions are changing minds on Capitol Hill, where the agency must overcome Republicans who are skeptical of increased regulation.

Rep. Michael Burgess (R-TX)

Republicans like Rep. Michael Burgess of Texas have long been against the FDA's plans to regulate laboratory-developed tests, thanks in part to the lobbying efforts of The American Clinical Laboratory Association (ACLA), which is threatening to sue the agency over its plan.

But lawyer Jeffrey Gibbs, who represents testing laboratories for Washington law firm Hyman Phelps & McNamara, told the New York Times that the opponents are now amenable to increased regulation. "It is more likely that the FDA will have a role in regulating laboratory-developed tests as a result of either congressional action or a guidance document issued by the agency," he said.

After years of delay at the hands of opponents, the FDA last year released a draft guidance document outlining its plans for increased regulation of the laboratory-diagnostics space, and promised to release a final guidance that takes into account public comment by the end of this year, an event that would initiate implementation of the plan.

Another avenue for change is the comprehensive 21st Century Cures bill to overhaul regulation of the biopharma, medical device and diagnostics industries, which has passed the House, and is awaiting action in the Senate. A section granting more power to the FDA over LDTs would be among the only parts of the bill that increase regulation, but such a move is supported by AdvaMed.

That's because, unlike ACLA, AdvaMed represents makers of testing equipment, which can be used outside of inside or outside of large centralized testing facilities. Their devices are already regulated by the agency, while providers of LDTs are overseen by the so-called CLIA rules administered by the Centers for Medicare & Medicaid Services.

Many believe the two-track system is unfair and unsustainable.

"Patients and their physicians should be able to trust the results of their tests, regardless of how or where a test is developed or performed," said Rep. Frank Pallone (D-NJ), in the New York Times article. "It does not make sense to regulate tests differently based on who develops them."

The recent and well-publicized revelations questioning the accuracy and technology of prominent diagnostics company Theranos demonstrate the sometimes murky and nontransparent environment in which some test providers operate, and should add to public pressure for enhanced regulations of diagnostics, to the benefit of the FDA.

After all, accurate diagnostics are the cornerstone of the medical community's desire for personalized medicine, referred to by President Obama and others as precision medicine.

- read the New York Times story (sub. req.)
- and the FDA report (PDF)