When the FDA authorized the first direct-to-consumer (DTC) BRCA test in March, they did so with the caveat that any positive test result requires confirmation and genetic counseling before it can be used to inform medical treatment. Historically, insurance will only cover BRCA testing if a person has a significant personal or family history of breast and ovarian cancer. However, studies have shown 20–50% of BRCA mutation carriers don’t meet coverage criteria, which could leave these patients and their physicians in a difficult position, as described in a recent article, “Stakeholders Urge Payors to Cover Confirmatory Testing for 23andMe’s DTC BRCA Test.”
We believe the right thing to do is offer people with suspected mutations from a DTC test access to an affordable physician-ordered clinical test from a CLIA-certified, CAP-accredited lab.
So today we’re announcing an important expansion of our Family Testing Program to include testing for people who‘ve taken a DTC BRCA test and tested positive for a mutation that significantly increases their risk for hereditary breast and ovarian cancer. Anyone who receives a positive result from a DTC BRCA test is eligible for the Family Testing Program rate of $50 for a test that’s ordinarily $249.
Color’s test, performed in our CLIA-certified, CAP-accredited, next generation sequencing lab can provide medically actionable information, unlike the DTC BRCA test. In addition to providing a comprehensive analysis of the BRCA genes, we will analyze 28 other genes associated with breast, ovarian, uterine, colorectal, melanoma, pancreatic, stomach and prostate cancers. Like all Color tests, clients will also receive access to a board certified genetic counselor, who can help them understand their test results, and use this knowledge to work with their healthcare provider to design a plan of action for managing and reducing their elevated risk.
To learn more and take advantage of confirmatory testing through Color’s Family Testing Program, email us at email@example.com.
Color is a modern health service that applies expertise in robotics, genomics, software and design to a crucial healthcare challenge: preventing or detecting conditions where early knowledge can improve health outcomes and reduce treatment costs. Color’s affordable, clinical-grade genetic tests help people understand their risk for hereditary cancer and heart conditions — knowledge that they and their doctors can use to create personalized health plans. Color tests are physician-ordered and include access to board-certified genetic counselors for clients and healthcare providers.