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Gene by Gene's Clinical, Research Arrays Exempt from New Myriad BRCA Testing Agreement

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Gene by Gene can still the return mutation status of the BRCA1 and BRCA2 genes to US and Canadian customers via its clinical and research-focused microarrays, despite a new agreement with Myriad Genetics that prohibits Gene by Gene from offering its BRCA single-gene and gene panel sequencing service within North America.

Houston-based Gene by Gene also recently received its College of American Pathologists accreditation for its laboratory, removing an obstacle to expanding its clinical testing services in the US.

David Mittelman, CSO at Gene by Gene, discussed the details of the Myriad agreement and CAP accreditation with BioArray News this week.

He said that all of Gene by Gene's array products, clinical or ancestry, are exempt from the agreement with Myriad, "even clinical arrays that report BRCA gene mutations."

It is unclear if other companies that offer array-based based testing and report BRCA-related information to clients may continue to do so or if they are technically at legal risk unless they reach a similar agreement with Myriad. Gene by Gene was the first company to reach a settlement with Myriad and all other litigation is still pending, Mittelman noted.

Gene by Gene and other genetic testing laboratories introduced sequencing-based BRCA testing in June, after the US Supreme Court ruled that several patents held by Myriad and others on isolated BRCA gene sequences were patent ineligible, while other claims on cDNA were eligible. Myriad and the other BRCA IP holders sued Gene by Gene and other labs, including Ambry Genetics, which, together with Gene by Gene countersued Myriad, alleging violation of antitrust legislation.

The settlement reached between Myriad and Gene by Gene allows the latter to offer its sequencing-based BRCA gene test outside of North America. But it also allows Gene by Gene to provide BRCA analysis anywhere, including North America, as part of broader array- or whole-exome or whole-genome sequencing-based services.

Mittelman noted that Gene by Gene offers a number of clinical arrays, including an inherited disease panel which tests for genetic variants associated with different types of Mendelian disorders, as well as a chromosomal microarray for the detection of constitutional genetic abnormalities. He said that Gene by Gene offers these clinical tests through physicians and hospitals, including "one of the largest [health management organizations] in Israel." He did not name the client.

In addition to clinical arrays, Gene by Gene offers ancestry testing via its Family Tree DNA business, as well as genome-wide genotyping on the Illumina OmniExpress platform as part of genome-wide association studies, for example.

Customers who order testing on either array, or via the company's whole-genome and whole-exome sequencing services, can now receive BRCA-related information, no matter where they are located, Mittelman said.

That might be appealing to some potential clients, given that Gene by Gene recently achieved CAP accreditation. Mittelman said that a "major milestone" for Gene by Gene growing its clinical business was "getting CAP accreditation for the lab." He said that CAP accreditation is "the highest level of accreditation you can get for doing clinical tests," and that the accreditation should also help the company win customers abroad.

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