Company also presents new data at ASRM 2026 showing sperm epigenetics predicts IUI success across clinics and physicians, and that sperm-derived cell-free DNA predicts sperm retrieval outcomes in men with azoospermia
BALTIMORE and SALT LAKE CITY, Oct. 26, 2026 / ACCESS Newswire / October 10, 2026 - Path Fertility™, the commercial brand of Inherent Biosciences, Inc. and a molecular diagnostics company advancing epigenetic testing for male fertility, today announced it has received a Direct to Phase II Small Business Innovation Research (SBIR) grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health (NIH). The two-year award, totaling $2 million, will fund development and clinical validation of an epigenetic diagnostic for non-obstructive azoospermia (NOA), the most severe form of male infertility, and its associated cancer risk.
The announcement coincides with the American Society for Reproductive Medicine (ASRM) 2026 Scientific Congress & Expo in Baltimore, where Path Fertility Chief Scientific Officer Kristin Brogaard, Ph.D., is presenting two studies today.
A new test for men with the most severe infertility
NOA affects roughly 1% of men worldwide and is linked to higher risks of cancer and cardiovascular disease. Current tests, including karyotyping and Y-chromosome microdeletion testing, leave many cases without an explanation.
Prior research by Dr. Dolores Lamb and collaborators, supported by Inherent Biosciences, found epigenetic changes ("epimutations") in MSH5, a DNA repair gene, in up to 19% of men with NOA. The finding points to a molecular pathway that may explain a significant share of otherwise unexplained cases and connects spermatogenic failure to broader health risks.
Under the new award, Path Fertility will:
Confirm how often MSH5 epimutations occur in a broader group of men with NOA through a multi-site clinical study
Develop a semen-based reflex test, removing the need for a separate blood draw
Measure MSH5 epimutations in 500 patients with colorectal cancer, a population known for DNA mismatch repair defects
Validate the assay in a CLIA-certified laboratory for commercial launch as a laboratory developed test
The test will be incorporated into NOA Guide, Path Fertility’s diagnostic that helps predict whether sperm can be retrieved surgically in men with NOA. NOA Guide also uses the sperm-derived cell-free DNA technology that Path Fertility further developed under a prior NICHD SBIR grant and is presenting at ASRM today.
"Men with non-obstructive azoospermia are often told there is no explanation for their infertility, and rarely told it may signal risks to their overall health," said Kristin Brogaard, Ph.D., co-founder and Chief Scientific Officer of Path Fertility and principal investigator on the award. "Our earlier work found MSH5 epimutations in nearly one in five of these men. This award lets us confirm that finding across multiple clinical sites and turn it into a simple semen-based test that gives men a real answer and flags health risks that deserve follow-up."
"This award is a strong vote of confidence in epigenetics as the foundation for better male fertility diagnostics," said Andy Olson, co-founder and CEO of Path Fertility. "With SpermQT, we showed that a 'normal' semen analysis can miss subfertile men. With NIH support, we're extending that platform to men facing the most severe infertility, and the data we're presenting at ASRM show the same approach producing actionable answers across male fertility care."
New data at ASRM 2026
Dr. Brogaard is presenting two studies today, Monday, Oct. 26, at the Baltimore Convention Center.
Oral presentation O-27: Sperm-derived cell-free DNA predicts sperm retrieval outcomes and reveals FSH-dependent biological subtypes of non-obstructive azoospermia 11:35–11:45 a.m. ET, Room 305 (Level 300), Oral Abstract Session: Reproductive Urology
In 67 men with NOA undergoing surgical sperm retrieval, the amount of sperm-derived cell-free DNA (cfDNA) in a semen sample predicted whether sperm would be found, and the direction of that link depended on follicle-stimulating hormone (FSH) level. In men with FSH below 20 IU/L, each 1% increase in cfDNA lowered the chance of successful retrieval by about 1.5 percentage points (p=0.002). In a subset with testicular pathology, cfDNA distinguished maturation arrest with an AUC of 0.79; no men with maturation arrest had sperm retrieved. The results suggest a non-invasive semen test, read alongside FSH, could help physicians counsel men and select candidates before surgery. The study was conducted with researchers at Baylor College of Medicine and Brigham Young University and was supported by a prior NICHD SBIR grant (1R44HD112264).
Poster P-102: Epigenetic sperm quality predicts IUI outcomes independent of physician and clinic variability in real-world practice 2:30–2:45 p.m. ET, Poster Hall Station 3 (Level 100)
Using real-world data from 537 men tested with SpermQT™ across 10 U.S. fertility clinics and 28 physicians, the study followed 202 couples through intrauterine insemination (IUI), averaging 2.8 cycles. The cumulative pregnancy rate was 22.0% when SpermQT was Normal and 0% when it was Abnormal (p=0.005), even though age and total motile count were similar between groups. The result held after adjusting for physician (p=0.012) and clinic (p=0.009), showing that sperm epigenetics predicts IUI success regardless of where or by whom a couple is treated. Co-authors include investigators from Baylor College of Medicine and US Fertility.
Abstracts are available in the ASRM 2026 meeting program.
About Path Fertility
Path Fertility™ is the commercial brand of Inherent Biosciences, Inc., a molecular diagnostics company based in Salt Lake City, Utah. Its flagship test, SpermQT™, is a clinically validated epigenetic sperm quality test that analyzes DNA methylation across genes related to sperm function to help physicians and couples choose the right fertility treatment path. SpermQT is supported by three peer-reviewed studies and is ordered by fertility specialists across the U.S. Path Fertility is also developing epigenetic diagnostics for non-obstructive azoospermia and other areas of reproductive and men's health. Learn more at pathfertility.com.
Research reported in this press release is supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health under Award Numbers R44HD112264 and R44HD121294. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Path Fertility and SpermQT are trademarks of Inherent Biosciences, Inc. All other trademarks are property of their respective owners.
