23andMe tackles infertility testing with big data player Celmatix

23andMe has concentrated on diversifying its offerings since falling out with the FDA over its genetic testing products a few years ago. Now the company is adding another chapter to its comeback story, striking a deal with big data company Celmatix to work on infertility testing.

Emily Conley, 23andMe's VP of business development

Both sides are staying quiet on financial details. But the agreement will combine Celmatix's more than 5,200 genetic biomarkers with 23andMe's "robust genetic database and research community" to improve diagnosis and treatment for infertility, the pair said in a statement.

Celmatix has "amassed a deep clinical database on infertility treatments" and "combining that platform with 23andMe's genetic database will create a uniquely powerful engine to fuel discoveries on the genetics of infertility," 23andMe's VP of business development, Emily Conley, said in a statement.

The partnership will allow New York-based Celmatix to launch its genetic tests and will also spur development of early screening tools that help doctors identify women at risk for premature decline of their ovarian function, a red flag for infertility. One in 8 couples in the U.S. struggle to conceive, and there are no comprehensive genetic tests for infertility in women or men. "We believe Celmatix's vision to provide women with genetic information that can inform proactive fertility management will ultimately have a meaningful impact on infertility outcomes," Conley said.

The deal is another feather in 23andMe's cap as it builds out its offerings and regains momentum following its falling out with the FDA. In 2013, the agency slapped the Mountain View, CA-based company with a warning letter for its $99 genetic tests, accusing it of selling its direct-to-consumer (DTC) spit tests without approval. 23andMe then pulled its TV, web and radio ads for the test.

But 23andMe bounced back, concentrating on deals with biopharma partners to keep its engine running. The company launched a new therapeutics group last year with Genentech vet Dr. Richard Scheller at the helm. The group plans to use human genetic data to uncover new therapies for common and rare diseases.

23andMe CEO Anne Wojcicki

23andMe has also made good with the FDA. Last February, the company got the agency's green light to market its genetic carrier test for Bloom syndrome, a rare disease affecting individuals of Ashkenazi Jewish descent, directly to consumers. In October, 23andMe launched an FDA-approved product, which includes a suite of genetic reports with information about health, ancestry, wellness and personal genetics.

"We've worked with the FDA for nearly two years to establish a regulatory path for direct-to-consumer genetic testing," 23andMe CEO Anne Wojcicki said at the time. "We are a better company with a better product as a result of our work with the FDA. This is an incredibly dynamic time in genetics and we're excited to be at the leading edge of bringing genetics directly to individuals as they begin to learn about their 23 pairs of chromosomes."

- here's the statement

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