Episona Inc., an epigenetics data company focused on
improving outcomes in reproductive health, announced today the launch of Seed,
an innovative new male fertility test, at the American Society for Reproductive
Medicine Scientific Congress& Expo. Seedis the first product on the market
to evaluate epigenetic changes on DNA to predict the risk for male
factorinfertility 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 patientswith
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 testingoptions 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 thatcan 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
methylationon 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.
Thanks for sharing. The male issue we had was the following. Dh's sperm dna analysis indicated he had no drills in his sperm. Adding mylow amh level- extremelly low! - natural conceiving became out of the question for us. We'd tried 5 iuis, 2 ivfs which failed before finally found ourselves at Biotexcom passing DE IVF. Dealing with male and female issues at the same time is tough by all means. Couples need to be extra patient..
ReplyDeleteThat's great you spread awareness about this. The following testings might be:
ReplyDeleteSemen analysis. Your doctor may ask for one or more semen specimens. Semen is generally obtained by masturbating or by interrupting intercourse and ejaculating your semen into a clean container. A lab analyzes your semen specimen. In some cases, sperm may be tested for in the urine.
Hormone testing. You may have a blood test to determine the level of testosterone and other male hormones.
Genetic testing. Genetic testing may be done to determine whether there's a genetic defect causing infertility.
Testicular biopsy. In select cases, a testicular biopsy may be performed to identify abnormalities contributing to infertility and to retrieve sperm to use with assisted reproductive techniques, such as IVF.
Imaging. In certain situations, imaging studies such as a brain MRI, bone mineral density scan, transrectal or scrotal ultrasound, or a test of the vas deferens (vasography) may be performed.
Other specialty testing. In rare cases. other tests to evaluate the quality of the sperm may be performed. such as evaluating a semen specimen for DNA abnormalities.