The US government is finally examining a regulatory loophole that has allowed companies like Theranos
to market diagnostic tests to patients without going through the US
Federal Drug Administration first. FDA officials pointed out today in a
hearing that these tests endanger patient safety — and that bad tests
can require costly clean-up.
The Energy and Commerce's Subcommittee on Health held a hearing in Washington today to discuss a controversial category of diagnostic tests called "lab developed tests" or LDTs. It gives companies that develop and conduct a diagnostic test in a
single lab the ability to avoid submitting their tests to the FDA before
using them on patients. The LDT category exists because research
hospitals often need to modify commercial tests to suit patient needs. So, today's hearing was designed to hear arguments for and against a change proposed by the FDA last year
that would require that developers of certain LDTs obtain approval
before they start to market their tests to patients. Developers would
also have to monitor customer complaints after they put out their tests.
The FDA wants to make sure that these tests "are accurate, reliable and that they do, in fact, identify a disease," said Jeffrey Shuren, director
of the FDA's Center for Devices and Radiological Health, during the
hearing. Right now, this form of verification isn't conducted by FDA or
federal lab inspectors. And that's a problem, Shuren told the
subcommittee. If diagnostic tests return inaccurate results, "physicians
can make the wrong decisions and patients can get hurt."
The FDA yesterday released a report
that discusses 20 LDTs that caused harm to patients, Shuren said. Among
them was a genetic breast cancer test that gave out inaccurate results
in 20 percent of cases.
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