If there is a grey area in medical devices and services regulation, this is the Laboratory Developed Tests one. Up to now, FDA has refused to define the rules of the game for 11,000 diagnostic tests performed at 2,000 labs in USA. This means that no official or external reviewer has analysed the clinical validity and clinical utility as it is done in any reagent and instrument. I can't understand why we have arrived at such a situation.
Fortunately
NYT reports that on July 31st, FDA announced that this will change.
The
agency said on Thursday that such discretion must end because
circumstances had changed. Lab-developed tests once were fairly simple,
often developed by a hospital for tests on its own patients. Now the
tests can be complex and are being developed by companies and marketed
widely.
Some
widely used commercial tests have never had to be reviewed by the
agency. These include Myriad Genetics’ breast cancer risk test, the
subject of a Supreme Court patent decision last year; the Oncotype DX
test from Genomic Health, which is used to determine if women with
early-stage breast cancer need chemotherapy; and noninvasive prenatal
tests for Down syndrome that are rapidly catching on.
In this blog I have supported
several times for a clear regulation of
these tests . Just the other day when looking at the statements of FDA commissioner, I was astonished:
Just as drugs need to be safe and effective for treating diseases,
medical devices used to help diagnose disease and direct therapy also
need to be safe and effective, Faulty
test results could lead patients to seek unnecessary treatment or to
delay or to forgo treatment altogether.
These statement raise more concerns about what US regulator has done after all these years. And european regulation is still worse in this sense. I have explained
such disaster previously and up to now there is no news. Some times I wonder why do we pay taxes, why do we have to be part of Europe. Enough is enough.