Episona has announced the launch of Seed, an innovative new male fertility test, at the American Society for Reproductive Medicine Scientific Congress & Expo. Seed is the first product on the market to evaluate epigenetic changes on DNA to predict the risk for male factor infertility and poor embryo development, offering physicians and their patients a valuable new tool for personalizing fertility treatment and increasing the chances of pregnancy sooner and more cost effectively.

"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. "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."

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. "Seed has the potential to provide my patients with the information needed to better guide their course of treatment. I look forward to bringing this new test to my practice and to helping my patients become pregnant sooner."

Seed's novel approach is based on the science of epigenetics. Epigenetics examines external or environmental factors such as aging, smoking, obesity, environmental exposure or even exercise that can cause changes to the layer on top of the DNA known as the epigenome. These modifications to the DNA alter how genes are expressed, or read, which in turn can impact how genes function. Episona focuses specifically on DNA methylation on the epigenome by looking at the differences in methylation between known fertile sperm DNA and infertile sperm DNA. Using microarrays from Illumina Inc., 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.

"The Seed test uses epigenetics, which allows us to look much more deeply at potential problems associated with impaired fertility in men,” said Dr. Paul Turek, an internationally known leader in men’s reproductive health and an Episona's scientific advisory board member.

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. 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, Episona's first commercial product, is initially being launched in the United States as a laboratory-developed test. 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.