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Gene by Gene Plans US Launch for Clinical Carrier Screening Array Focused on Jewish Populations

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Gene by Gene will later this year debut a genetic disease carrier screening service focused on Jewish populations in the US.

Elliot Greenspan, the Houston, Texas-based company's account manager for Israel, said that the service relies on a custom Illumina iScan BeadChip, and was designed in cooperation with health management organizations in Israel, where it is already available for such testing.

Greenspan spoke with BioArray News during the American College of Medical Genetics and Genomics' annual meeting, held last week in Nashville, Tenn. He said that genetic counselors in Israel often spend too much time determining individuals' ancestry before deciding to test them for population-specific mutations.

Gene by Gene's test removes the need for such information by including the most common disease-causing mutations found in various Israeli populations, including Ashkenazi, Sephardi, and Mizrahi Jews, as well as Palestinians, Bedouins, and Druze. By running a client's sample on the array, counselors therefore do not need to determine, for example, if a client's grandfather was a Mizrahi Jew, in order to request testing for mutations associated with common genetic diseases in that population.

"The idea behind this product … is to remove the need for pedigree information," said Greenspan. "You don't have to remember what your pedigree is," he said. "You can just have the counseling session and learn about your carrier status," Greenspan added. "They will provide the risk assessment, and have the conversation after the test about what it means."

Gene by Gene's test covers some 700 mutations associated with 260 diseases, including the 12 most common BRCA1 and BRCA2 SNPs. The company reached an agreement with Myriad Genetics in February that permits it to test for BRCA mutations using its clinical and research arrays and whole-genome and whole-exome sequencing services. Gene by Gene is still barred from offering single-gene and gene-panel BRCA tests in North America, though it may do so elsewhere.

Upon launch, this test will be Gene by Gene's first clinical array in the US, and will berun in its CLIA and CAP-compliant laboratory in Houston. Greenspan noted that the array has become a "go-to test" in Israel as it was designed with and offered through the country's two largest HMOs: Clalit Health Services and Maccabi Health Care Services.

"The test is currently becoming more and more mainstream in the state of Israel," said Greenspan. "[That's] because it is easier, [and] the genetic counselors can facilitate more people in less time."

Greenspan estimated that the potential US market for the new service is about equal in size to the Israeli market. He noted that the SNPs on the array are already "very common because the Jewish population is very endogamic," but noted that the chip will include mutations associated with rarer diseases that are found in the general US population, such as those related to Duchenne muscular dystrophy, Superior mesenteric artery syndrome, and Fragile X syndrome.

In the US, there are other companies and laboratories that offer screening for mutations associated with the Ashkenazi Jewish population, Quest Diagnostics, Sequenom, and Emory Genetics Laboratory among them. Recently, EGL partnered with Potomac Falls, VA.-based Tessarae to develop a pan-ethnic carrier screen based on the Affymetrix GeneChip platform that can determine a person's carrier status for more than 90 single-gene disorders in one test.

According to Greenspan, Gene by Gene's experience in Israel, might give the firm an advantage in the US, though. "We have built and designed this test with the state of Israel for that population and it goes beyond Ashkenazi," he said. "It is a great starting point for you and your spouse to ascertain the risks associated with having a child, and what precautionary measures one can take if something comes up as a red flag."

As for Gene by Gene's approach to the market, Greenspan said that company is looking into various ways for marketing the test to clinicians and gaining reimbursement for it.

"In the US there are different philosophies than there are in the state of Israel," said Greenspan. "How do you want to deal with insurance? How do you want to deal with direct pay? And we are vetting these decisions before we launch," he said. "The product is more or less complete," Greenspan added. "It's the logistics that we are working out now."

Just 'Gene by Gene'

Gene by Gene was established as Genealogy by Genetics Ltd. in 2000 with the launch of Family Tree DNA, a genetic genealogy testing service that offers array-based autosomal DNA testing among other assays. Between 2008 and 2012, the company added three other business units: DNA Traits, which offered health-related tests; DNA Findings, which focused on relationship tests, such as paternity or sibling tests; and DNA DTC, which was created to serve the consumer genomics market.

According to David Mittelman, CSO at Gene by Gene, the company decided late last year to simplify their branding.

Mittelman told BioArray News at the conference that the company will sell the clinical array and all other clinical and research tests under the Gene by Gene brand. The company will continue to sell all ancestry and genealogy products under its Family Tree DNA brand, Mittelman said.

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