Yale Cancer Genetic Counseling has issued a position statement on how it chooses the labs that it refers its patients to for BRCA testing.
The position statement is necessary, according to the group, due to certain labs' "manipulative tactics to secure their profits in this volatile field." Since the US Supreme Court's decision last year in Association for Molecular Pathology et al. v. Myriad Genetics, the market for BRCA testing to gauge women's risk of hereditary breast and ovarian cancer has suddenly become a highly competitive space. Ellen Matloff, director of Cancer Genetic Counseling at Yale School of Medicine, was among the original plaintiffs in this lawsuit.
In this more aggressive marketing environment, counselors at Yale say that certain, unnamed labs are pressuring genetic counseling centers to administer their tests over competitors'. "Genetic counseling centers have reported receiving pressure from clinicians to use specific laboratories for testing, learning that these clinicians are receiving financial incentives or hefty speaker's fees from these laboratories," the Yale groups says. "The conflict of interest is clear. We have reports of other laboratories threatening to siphon off referring clinicians if their laboratory isn't used."
At Yale, the counselors have outlined their criteria for picking the lab that performs BRCA testing for its patients. Quality, ensuring that the lab does accurate and comprehensive testing, tops the list. Then, counselors also factor in the test's turnaround time, its cost, and whether the lab shares patient's de-identified variant data in open-access databases.
"Whenever possible we will choose laboratories that have pledged to make all of their past, present, and future gene data publicly available in order to allow this important information to be freely accessible to all clinicians and researchers, to further the advancement of medical knowledge and to best serve patient care," the counselors state. "We will not support laboratories that hoard data."
Labs, patient groups, and many healthcare providers have joined a controversial, but fast-growing movement to share information on so-called variants of unknown significance. A recent article in PGx Reporter explored this issue in-depth.
The Yale counselors have also pledged not to accept any gifts, including speaking fees, or financial support, from testing labs, and to continue to update their lab choices as the BRCA testing market evolves.