GeneDx, the Bio-Reference Laboratories subsidiary, has launched a full panel of inherited cancer tests that includes assays for the BRCA1/2 genes. The Maryland-based GeneDx is the latest company to test the BRCA test market after the U.S. Supreme Court ruled earlier this summer that Myriad Genetics could not hold patents on unaltered genes. Despite losing the case, Myriad and its affiliates have sued other labs offering BRCA assays for patent infringement, claming they are infringing on its proprietary testing methods. A GeneDx spokesperson declined to comment on whether the risk of litigation was factored into their decision. GeneDx’s BRCA products will include a panel for mutations common to Ashkenazi Jews. The other tests include a 26-gene panel for breast and ovarian cancer, an 18-gene panel for pancreatic cancer, an 18-gene panel for colorectal cancer, and an 11-gene panel for endometrial cancer. They are being marketed under the OncoGeneDX brand. “We are excited to be launching this suite of tests, as we can now bring our extensive experience in genetic testing along with cutting-edge technologies to bear on this very important public health problem that has tremendous impact on patients and their families,” said Sherri Bale, GeneDx’s managing director. The GeneDx […]
GeneDx, the Bio-Reference Laboratories subsidiary, has launched a full panel of inherited cancer tests that includes assays for the BRCA1/2 genes.
The Maryland-based GeneDx is the latest company to test the BRCA test market after the U.S. Supreme Court ruled earlier this summer that Myriad Genetics could not hold patents on unaltered genes.
Despite losing the case, Myriad and its affiliates have sued other labs offering BRCA assays for patent infringement, claming they are infringing on its proprietary testing methods. A GeneDx spokesperson declined to comment on whether the risk of litigation was factored into their decision.
GeneDx’s BRCA products will include a panel for mutations common to Ashkenazi Jews. The other tests include a 26-gene panel for breast and ovarian cancer, an 18-gene panel for pancreatic cancer, an 18-gene panel for colorectal cancer, and an 11-gene panel for endometrial cancer. They are being marketed under the OncoGeneDX brand.
“We are excited to be launching this suite of tests, as we can now bring our extensive experience in genetic testing along with cutting-edge technologies to bear on this very important public health problem that has tremendous impact on patients and their families,” said Sherri Bale, GeneDx’s managing director.
The GeneDx spokesperson said the tests would be priced competitively and feature fast turnaround times but could not release exact numbers because of ongoing negotiations with insurers. Myriad had been charging about $3,000 for the BRCA test when it held a valid patent. Other firms, such as GeneByGene, are charging $795.
“We’ve had significant interest from both current clients and new clients” for the tests, the GeneDx spokesperson said.
The New Jersey-based Bio-Reference, which has shown rapid growth at a time when other large laboratories are struggling with flat revenues and earnings, has indicated that molecular and esoteric testing is a large driver of its current growth and plans to continue expanding offerings in that area.
Takeaway: Another lab is getting into the BRCA testing segment as a result of the Supreme Court’s decision on gene patents. This area is likely to continue growing as other companies develop their own tests.
