Episona debuts epigenetic test for male factor infertility

Courtesy of Episona

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.


How ICON, Lotus, and Bioforum are Improving Study Efficiency with a Modern EDC

CROs are often at the forefront of adopting new technologies to make clinical trials more efficient. Hear how ICON, Lotus Clinical Research, and Bioforum are speeding database builds and automating reporting tasks for data management.

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.


Suggested Articles

The ADDF announced its second round of research awards, with a total of $6 million in new funding for diagnostic tests.

Takeda teamed up with Enzyre to develop an at-home diagnostic device that will help people with hemophilia determine their own coagulation status.

Foundation Medicine received a diagnostic approval from the FDA for selecting HR+/HER2- breast cancer patients for treatment with Novartis' Piqray.