Episona launched its epigenetic male fertility test in the U.S., the first such test on the market that predicts male factor infertility and poor embryo development. The test will augment current methods of evaluating male fertility and help patients and physicians personalize fertility treatment.
Male factors account for around half of infertility cases, and about a quarter of infertility cases are unexplained. And while semen analysis can shed light on sperm count, motility and shape, its utility is limited.
The test, Seed, is a physician-ordered kit that can be used at home or in the clinic, according to a statement. Samples are analyzed at a CLIA-certified lab and two weeks later, physicians receive a report that can help guide treatment. For example, Seed results could suggest a couple go straight to in vitro fertilization rather than to the less invasive intrauterine insemination, Episona CEO Alan Horsager told FierceMedicalDevices. And further on in IVF, results could indicate a need for a sperm donor rather than an egg donor.
Seed works by using an array from Illumina to look at epigenetic marks on top of the DNA, Horsager said. These are methyl groups that bind on top of the DNA to regulate which genes are active and inactive, he said.
“The normal [DNA methylation] process can be thrown out of whack by factors, such as aging, environmental factors and smoking,” Horsager said. “What we’re doing is looking at the changes in sperm and correlating them with problems in infertility.” The test examines more than 480,000 regions on sperm DNA for abnormal methylation, looking at what differentiates known fertile sperm DNA from infertile sperm DNA, according to the statement.
Seed is initially being launched in the U.S. as a laboratory-developed test. The company has eyes on expanding to Canada and Europe, too, Horsager said. The stable nature of the samples allows them to be shipped at ambient temperatures with no disruption to the epigenome, Horsager said. So there would be no difference to the way the test is conducted in other markets aside from shipping time.