First multi-center clinical study of cell free RNA and DNA methylation biomarkers in seminal fluid shows promise for accurate, non-invasive detection of clinically significant prostate cancer.

SAN LEANDRO, Calif.--Fellow Health, a company focused on advancing male reproductive health through patient-centric testing solutions, today announced the presentation of four posters at the American Urological Association (AUA) 2025 meeting, taking place April 26–29 in Las Vegas. The studies highlight mail-in semen analysis as a potential post-PSA reflex test as well as an alternative to in-clinic post-vasectomy semen analysis (PVSA).

In a large multi-center study, researchers demonstrated that cell free RNA expression and DNA methylation biomarkers in seminal fluid can differentiate clinically significant prostate cancer (Grade Group 2+) from indolent cancer or no cancer. The RNA study identified a panel of transcripts that when combined with age and PSA resulted in an AUC of 0.827. Similarly, using a proprietary method for analyzing DNA methylation combined with AI, an AUC of 0.838 was obtained. Together, the findings point to a novel, non-invasive, mail-in test that could reduce unnecessary biopsies in men with elevated PSA.

“Too many men with elevated PSA undergo unnecessary prostate biopsies. In our study, even in the cohort that had undergone MRI prior to biopsy, almost 70% of men had either indolent cancer or no cancer,” said Kim Clark-Langone, PhD, Senior Vice President of Research and Development at Fellow Health. “These studies show that seminal fluid holds untapped diagnostic power. We see mail-in semen analysis as a novel post-PSA reflex test that can prevent unnecessary biopsies."

The second set of studies evaluated both the stability and real-world performance of mail-in PVSA. Researchers found that sperm samples remained stable over a 10-day period when stored in Fellow Health’s proprietary preservative, and the retest rate was just 4.2% higher than with fresh samples. These findings validate Fellow Health’s mail-in PVSA as a reliable, efficient alternative to in-clinic testing.

“Equity in men’s reproductive health starts with meeting people where they are,” said James F. Smith, MD, MS, Chief Medical Officer and NYS Laboratory Director at Fellow Health. “Mail-in PVSA testing removes barriers like geography, time, and stigma. This is about more than convenience—it’s about ensuring every man has access to high-quality care, no matter his circumstances.”

Presentation Details

• IP18-29: Mail-In Semen Analysis vs Fresh Sample for Post-Vasectomy Semen Analysis (PVSA): Identifying an efficient approach to achieving post-vasectomy clearance

• IP18-28: Is a Fresh Semen Analysis necessary for a Post Vasectomy Semen Analysis?: Assessment of Stability of Sperm Concentration over a 10-day Time Frame as a Model for Post Vasectomy Semen Analysis Using the Fellow System

• IP21-28: Detection of clinically significant prostate cancer in seminal fluid using RNA biomarkers: Results from a large multi-center clinical study

• IP21-30: A novel DNA methylation based approach to detect clinically significant prostate cancer in seminal fluid in a large multi-center clinical study

About Fellow Health

Founded in 2018, Fellow Health is a pioneering company dedicated to advancing male reproductive health through innovative and comprehensive mail-in testing solutions. The company partners with more than 1,800 top clinical practices, processing over 400 patient samples daily through their CLIA-certified lab, and is the only mail-in fertility test with peer-reviewed validation data. Fellow Health has secured funding from leading life sciences and technology investors, including 5AM Ventures, Genoa Ventures, Human Capital, and Mantis Venture Capital.