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carry out multi-site clinical trials of the Eeva test, and to further develop the capabilities of the system. Financial terms of the deal were not made public.
The company is asking the FDA to approve the use of the Eeva test as an adjunct to the standard methods of embryo evaluation. But Goldenstein says the Eeva test may eventually be used as a standalone assessment. In the future, it may incorporate some of the standard tasks done by embryologists, such as counting the number of cells in each embryo.
In addition to improving the predictions of embryologists, Auxogyn plans to try to show that the Eeva test will boost key measures of success, such as the rate of pregnancies or live births for each IVF cycle. Such clinical trials would reveal clear results only if a single embryo were used in each mother, Goldenstein says. The trials would be easier to conduct in Europe, where single embryo transfers are considered the standard of care in some countries, she says.
In the United States, the average number of embryos transferred is two or more for women in most age groups, according to the CDC.
“The US has one of the highest success rates in the world, but we also have the highest rates of multiples,’’ Goldenstein says.
The global infertility industry has been growing by 5 to 10 percent a year, and an estimated five million babies have been born with the help of IVF since the technique was first used in humans in 1978. About one in six couples worldwide experience some form of difficulty with fertility, according to the European Society of Human Reproduction and Embryology.
Auxogyn has raised $38 million in two funding rounds from backers including Kleiner Perkins Caufield & Byers, SR One, TPG Biotech, and Merck Serono Ventures, the venture arm of Merck Serono, a unit of the German pharmaceutical company Merck
Goldenstein did not disclose revenue projections for the Eeva test, but she said Auxogyn’s pricing structure would make it easy for fertility clinics to adopt the technology. The clinics will pay low initial capital costs to have their existing incubators retrofitted for video monitoring of embryo growth. The fertility practices will then pay a fee for each use of the test. That cost will probably be passed along to patients as an optional add-on service to their basic IVF package, Goldenstein says.
US clinics where the systems have been tested are interested, Goldenstein says.
“We have a hard time taking them out after the studies,’’ she says.
Four California fertility practices participated in studies of the Eeva test, including the Pacific Fertility Center in San Francisco. Its medical director, Dr. Philip Chenette, said Auxogyn’s test “provides a new tool to investigate an old problem.”
“This technology provides new insights that help improve embryo selection and potentially improve IVF outcomes and pregnancy rates,” Chenette said in a press release Auxogyn issued at the San Diego conference.