Quest Collaborates With French Researchers to Provide BRCA Variants Data

Quest Diagnostics wants to crack the BRCA gene wide open. The New Jersey-based national laboratory has joined forces with a French research institute to create a wide-ranging, data-sharing initiative on the gene, which can often predict cases of breast cancer. Quest and Inserm, the French National Institute of Health and Medical Research, have launched BRCA Share, which will provide labs and researchers access to a large accumulation of research into the variants of the BRCA1 and BRCA2 genes. The database is already of a significant size, the result of test data gathered by 16 laboratories throughout France that participate in the Unicancer Genetics Group (UGG). It will be used to help clarify test results for patients whose BRCA assay identifies a gene variant of uncertain significance. There are more than 3,900 unique variants in the database, of which about 57 percent are classified as being an unknown variant. “BRCA Share is a new model for public and private collaboration in an age of scientific openness and genomics discovery,” said Quest Chief Executive Officer Steve Rusckowski in a statement. “This initiative will harness the power of diagnostic insights to illuminate the role of genetics in inherited cancer. It reflects Quest’s value as a provider of insights into disease that enable people to take actions to improve their health. Inserm and UGG’s experience in BRCA data curation and excellence in BRCA science make it eminently well suited to co-lead this initiative with Quest.” The initiative received praise from one stock analyst. “This collaboration aiming to improve BRCA variant knowledge is the most robust to date,” wrote William Blair & Co. analyst Amanda Murphy in a recent report. “We believe this initiative supports the view that BRCA variant data has value and is a critical component of delivering high-quality clinical interpretation—particularly given that those who want to access the database for commercial purposes will have to pay license fees.” BRCA Share has already picked up a significant client: North Carolina-based LabCorp, which rivals Quest in size as a national laboratory. However, the initiative has also created some volatility among the other labs offering BRCA testing. The Utah-based Myriad Genetics, which had held a patent on the BRCA gene until the U.S. Supreme Court ruled in 2013 that single genes were not proprietary, saw its stock drop by about 5 percent shortly after Quest made the announcement on April 21. Murphy also noted that the BRCA market was further thrown into turmoil by the announcement of a small California lab that it would introduce a low-cost version of the BRCA test (see Industry Buzz, page 8). But when it comes to data testing, Murphy noted that BRCA Share is of intermediate size, similar to the Breast Cancer Information Core (BIC) database operated by the National Human Genome Research Institute, but about half the size of ClinVar, another database operated by the National Center for Biotechnology Information. And she also observed that while the Quest collaboration may present a blow to Myriad, it is not out of the game. Murphy said that Myriad has moved forward with combining BRCA testing into panels that also test for ovarian and colon cancer risk, and that it is refining its current tests to make them more sensitive. “As data has apparently become more of a focus and labs working together could erode this advantage over time, we continue to believe that Myriad’s vast database—amassed since it began offering BRCA1/2 in 1996 and which now includes some of the newer genes it is testing on the MyRisk panel—represents an advantage,” Murphy wrote. Takeaway: Quest Diagnostics’ initiative to open up research into BRCA gene variants, is introducing uncertainty into a portion of the molecular testing market.