A controversy has been brewing under the surface for several months in the genetic testing world. Namely, will BRCA carriers with ovarian cancer be forced to undergo BRCA testing a second time – at >$4000 a pop – in order to qualify for a new drug called Olaparib. Why? The FDA has approved PARP-inhibitor Olaparib for patients with advanced ovarian cancer who carry germline BRCA mutations “as detected by an FDA-approved test”. The only FDA-approved test for this purpose is Myriad Genetics’ “BRACAnalysis CDx”. BRACAnalysis CDx has been described as “analytically the same” as BRACAnalysis, which is the standard BRCA test offered by Myriad. Since the fall of the BRCA patent in June 2013, we’ve seen that multiple laboratories offer high-quality BRCA testing at half the price, or less, than Myriad Genetics. And all of the competitor laboratories share their data in public databases, improving the quality of patient care and medical research worldwide. Myriad continues to hoard patient data in their own private database, in spite of being widely criticized for these practices.
The timing of this controversy is ironic (or is it?), in that within the past month Myriad finally dropped its multiple lawsuits against other laboratories offering BRCA testing. And yet, once again, Myriad appears to be in an exclusive position to offer BRCA testing, this time for Olaparib eligibility.
What is the potential fall-out here?
- Is it possible that all ovarian cancer patients, even those with known BRCA mutations found at Myriad Genetics, will now have to undergo ‘BRACAnalysis CDx’, before they will be approved to take Olaparib? Will this mandate be particularly likely for patients whose mutations were detected at laboratories other than Myriad Genetics?
- Will clinicians be less likely to order genetic testing from other laboratories of equal quality? Will they insist that all tests go to Myriad? Has the 15+ year BRCA monopoly simply been reborn?
- If a patient has ovarian cancer, will there be a push for oncologists and nurses to immediately order BRACAnalysis CDx, instead of panel testing? If so, this will likely result in the under-diagnosis of other ovarian cancer syndromes that would be detected on larger panels. This is particularly concerning because these clinicians are not generally board certified in genetics and may miss other ovarian-cancer syndromes, like those caused by mutations in BARD1, BRIP1, MSH2, MLH1, MSH6, PALB2, and TP53.
- Is the thinking on the street about repeated BRCA testing, “Don’t worry about the unnecessary added health care costs, your insurance company will pay for it”? At $4000+ per patient x 20,000 new cases of ovarian cancer per year, that is an unacceptable answer.
- And if, as we hope, PARP-inhibitors prove to be effective in treating advanced ovarian cancer, they may later be used in treating early-stage ovarian cancer as well as breast, pancreatic and other cancer types. All of these patients would then require BRACAnalysis CDx, and the scope of the problem would be magnified.
Setting up an expensive and laborious pathway for laboratories to become FDA-approved for genetic testing may essentially eliminate the smaller laboratories that have begun offering high-quality, lower-cost genetic testing since the BRCA patent fell in June 2013. Now, less than 2 years from that historic Supreme Court victory for consumers, clinicians and clinical medicine, we may be opening the door for large laboratories to again take patients and all of their data hostage as a monopoly superpower. Let’s learn from over a decade of past mistakes and prevent this error from thwarting the future of personalized medicine.
Photo by thierry ehrmann, via Flickr, CCPL