Episona has raised approximately $4 million in seed funding, which will bankroll the commercial expansion of its first product: an epigenetic test that predicts male factor infertility and poor embryo development.
The test, called Seed, screens for changes in epigenetic marks on DNA. These are methyl groups that bind on top of DNA and influence which genes are active or inactive. The test uses microarrays from Illumina to examine more than 480,000 regions on sperm DNA for abnormal methylation, according to the statement. It then assigns a relative risk for male factor infertility or poor embryo development.
“The normal [DNA methylation] process can be thrown out of whack by factors such as aging, environmental factors and smoking,” Episona CEO Alan Horsager previously told FierceMedTech. “What we’re doing is looking at the changes in sperm and correlating them with problems in infertility.”
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"Male factors contribute to at least half the cases of infertility; yet, nearly all the current testing has focused on women,” said Simon Harrison, Ph.D., the lead investor and a member of the Pasadena Angels, in a statement. “While new technologies on the male side are making semen analysis easier and more convenient, they continue to rely on the age-old sperm test that hasn't evolved in decades.”
Semen analysis can tell us about sperm count, motility and shape, but the test is far from perfect. Launched last October, Seed is a physician-ordered kit that may be used in the clinic or at home. Samples are sent to a CLIA-certified lab for analysis, and physicians receive a report two weeks later that can help guide treatment.
For instance, Seed results could help patients and physicians decide to proceed with less invasive intrauterine insemination or to skip straight to in-vitro fertilization (IVF), the company said in the statement. The test can also shed light on problems with IVF or why it has failed, and could help determine if the couple would benefit from a sperm donor rather than an egg donor.
Seed was initially rolled out in the U.S., and it is now available in some fertility clinics in Canada. In addition to expanding sales and marketing for Seed, the funding will also support technology development. Episona is looking to create epigenetics-based tests for other indications, such as neurodevelopmental disorders and ADHD.