PS Fertility Awarded Prestigious NIH Fast-Track Grant for Revolutionary Fertility Test

Charlottesville, VA (September 25, 2025) – PS Fertility is pleased to announce that it has been awarded a NIH SBIR Fast-Track grant. This $1.7 million grant, entitled “PS Detect: A Diagnostic Test for Male Fertility/Infertility,” is expected to run over the next three years. The grant will fund ongoing research related to PS Fertility’s novel male fertility biomarker, which is measured by a proprietary test, PS Detect. 

PS Fertility’s commercially available diagnostic test detects phosphatidylserine, a biomarker on sperm that is needed for fertilization of an egg. Future studies are expected to target topics ranging from the overall stability of this biomarker over time to the specific clinical relevance of correlation with pregnancy. 

Infertility affects 1 in 6 couples in the United States, and approximately 50% is due to a male cause. Current conventional semen analysis only provides a sperm count and assesses its morphology and motility. However, it does not provide information on a sperm’s ability to fertilize an egg. 

While men are typically assumed to be fertile if sperm are morphologically sound, are motile, and within acceptable ranges for total count, this assumption is flawed. Research has found that many men are infertile despite otherwise normal semen parameters. 

When male infertility is misdiagnosed, the full burden of fertility treatment typically shifts fully to the female partner. Without addressing the male fertility factor, couples can spend time and money undergoing fertility treatment options, such as intrauterine insemination (IUI) or conventional IVF, that still may not result in a pregnancy.

PS Detect, coupled with a basic semen analysis, provides the opportunity for providers to offer a more complete assessment of male fertility. With support from this NIH SBIR grant, PS Fertility will be able to continue empowering patients and physicians with more insights to guide their fertility journey.  

“NIH SBIR grants are reviewed by leading experts in the field and awarded to promising technologies. Thus, obtaining one of these grants is an incredibly positive achievement for the company, confirming that the science and initial data has been accepted,” says Dr. Jeff Lysiak, Chief Science Officer at PS Fertility and former professor of urology at University of Virginia. “Now, it’s time to further develop the product and expand clinical studies to make a greater impact in helping couples have a baby.”

PS Fertility is a reproductive science company dedicated to advancing diagnostics and solutions for male infertility. Based in Charlottesville, Virginia, PS Fertility’s work is built on groundbreaking discoveries in sperm biology, including the critical role of phosphatidylserine in fertilization. Through innovation, research, and compassion, PS Fertility is helping couples around the world find answers and possibilities for growing their families. For more information, visit www.psfertility.com.