By Diagnostics World Staff
October 17, 2016 | Episona, an epigenetics data company based in Pasdena, Calif., today announced the launch of its male fertility test, Seed. Seed evaluates epigenetic changes to DNA to predict the risk for male factor infertility and poor embryo development.
"Physicians have long relied on the traditional semen analysis as the sole option for determining the male's role in fertility," said Episona President and CEO Alan Horsager, Ph.D. in a statement. "While semen analyses provide valuable information on sperm count, motility and morphology, they offer little insight into the more complex factors related to male fertility or into the male's role in embryo development. By combining the latest advances in science and technology, Seed provides patients with previously missing information about their fertility and we believe this has the potential to transform fertility care."
Episona focuses specifically on DNA methylation, comparing methylation of known fertile sperm DNA to infertile sperm DNA. Using Illumina microarrays, Seed examines over 480,000 regions on sperm DNA for abnormal methylation at different gene sites important to fertility. A relative risk is then assigned to each abnormal location for either male factor infertility or poor embryo development.
Seed is a physician-ordered test offered in a simple fertility kit for use at home or in a fertility clinic. Samples are sent to a CLIA-certified lab for analysis. Within two weeks physicians receive a detailed two-part interactive report on the patient’s risk of male factor infertility and poor embryo development. Male factor risk can help identify the severity of a patient’s case, helping both the physician and patient understand whether they should spend time and money pursing less invasive procedures such as intrauterine insemination (IUI) or move directly to in vitro fertilization (IVF). By analyzing sperm’s role in embryo development, Seed results can help identify problems that might occur with IVF and provide some answers if an IVF cycle fails or, in the case of seeking a donor, whether a male or female donor would be preferred.
"Male factors contribute to about half of the cases of infertility in couples, yet testing options for men have been woefully lacking. What's more, about a quarter of infertility cases are unexplainable," said Dr. Richard T. Scott, Jr., a founding partner at Reproductive Medicine Associates of New Jersey, and an Episona scientific advisory board member, in the same statement.
Episona has evaluated Seed in two clinical studies, with both demonstrating clear correlations between epigenetic abnormalities and male factor infertility. The first was a retrospective study involving 127 IVF patients and 36 known-fertile controls. The results of this study were published in Fertility & Sterility in August 2015 (DOI: 10.1016/j.fertnstert.2015.08.019). The second study was prospective and involved more than 200 patients from multiple clinical centers and 96 know-fertile controls. Episona intends to submit these study results for publication in a peer-reviewed journal early next year.
Seed is Episona's first commercial product, and is initially being launched in the United States as a laboratory-developed test. Some of the nation's leading fertility clinics participated in the early clinical studies and intend to make Seed available to their patients as soon as next month, the company reported, including clinics in New Jersey, Colorado, California, and Texas.
Episona estimates there are more than 1.2 million couples seeking fertility care each year in the United States alone. The worldwide fertility market is estimated at $30-40 billion by Harris Williams & Co.