PS Fertility has been awarded a $1.7 million NIH SBIR Fast-Track grant to advance research on PS Detect, a diagnostic test for male fertility assessment. The three-year grant will fund ongoing studies of the company’s phosphatidylserine biomarker, which measures sperm’s ability to fertilize eggs.

The US-based company’s diagnostic test addresses limitations in current male fertility assessment. Conventional semen analysis only evaluates sperm count, morphology, and motility but does not determine fertilization capability. Research shows many men remain infertile despite normal semen parameters under traditional testing methods.

Infertility affects one in six couples in the United States, with approximately 50% attributed to male factors. When male infertility goes undiagnosed, the burden of fertility treatment typically shifts entirely to female partners, who may undergo treatments like intrauterine insemination or IVF that may not address the underlying male factor.

PS Detect measures phosphatidylserine, a biomarker on sperm required for egg fertilization. Combined with basic semen analysis, the test aims to provide a more comprehensive assessment of male fertility potential.

“NIH SBIR grants are reviewed by leading experts in the field and awarded to promising technologies,” said Dr. Jeff Lysiak, Chief Science Officer at PS Fertility and former University of Virginia urology professor. “Now, it’s time to further develop the product and expand clinical studies to make a greater impact in helping couples have a baby.”

The grant will support research on biomarker stability over time and clinical correlation with pregnancy outcomes. Future studies will examine the diagnostic test’s ability to predict fertilization success and guide treatment decisions for couples experiencing infertility. By providing more accurate assessment of male fertility factors, the technology could help optimize treatment selection and improve success rates.

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