Fellow Health to Present Groundbreaking Research on Prostate Cancer Biomarkers and Mail-In PVSA Testing at AUA 2025
Fellow Health, a pioneering healthcare company dedicated to advancing male reproductive health through innovative, patient-centered diagnostics, today announced that it will present four original research posters at the American Urological Association (AUA) 2025 Annual Meeting, taking place April 26–29 in Las Vegas, Nevada. These presentations underscore the company’s commitment to transforming urological care by leveraging mail-in diagnostic technologies and biomarker-driven testing.
The research being presented by Fellow Health includes two major studies focused on prostate cancer diagnostics and two additional studies evaluating the performance and stability of mail-in post-vasectomy semen analysis (PVSA). Collectively, the studies suggest promising new avenues for non-invasive, accessible diagnostic alternatives that may improve clinical outcomes while reducing unnecessary procedures and expanding patient access to care.
Unlocking the Potential of Seminal Fluid for Prostate Cancer Diagnosis
In one of the company’s most compelling research highlights, Fellow Health scientists—collaborating with multiple clinical partners—conducted a large multi-center study exploring the use of seminal fluid biomarkers to improve prostate cancer detection. Specifically, the researchers investigated whether cell-free RNA expression and DNA methylation signatures in semen could distinguish between clinically significant prostate cancer (Grade Group 2 or higher) and cases involving indolent or no cancer.
In the RNA-focused portion of the study, a novel panel of gene transcripts was identified in semen samples. When these molecular signatures were combined with patient age and prostate-specific antigen (PSA) levels, the researchers achieved an area under the receiver operating characteristic curve (AUC) of 0.827—a strong indicator of the test’s diagnostic accuracy.
Meanwhile, the DNA methylation analysis employed a proprietary extraction and quantification method developed by Fellow Health. By integrating artificial intelligence to interpret the methylation data, the research team achieved an even higher AUC of 0.838. This result underscores the potential for DNA methylation biomarkers to provide reliable, early insights into prostate cancer aggressiveness in a non-invasive format.
Together, these findings mark a significant advancement in the field of urologic diagnostics. By utilizing semen—a fluid that can be collected at home without the need for specialized medical procedures—Fellow Health has demonstrated the feasibility of developing a next-generation, mail-in test for prostate cancer screening. Such a test could serve as a reflex follow-up to elevated PSA results, potentially sparing thousands of men each year from unnecessary prostate biopsies.
“Too many men with elevated PSA undergo unnecessary prostate biopsies,” said Kim Clark-Langone, PhD, Senior Vice President of Research and Development at Fellow Health. “In our study, even in the subgroup of men who had MRI imaging prior to biopsy, nearly 70% were found to have either indolent cancer or no evidence of cancer at all. This points to a significant opportunity to reduce over-treatment by integrating semen-based biomarker testing into the diagnostic workflow.”
Clark-Langone added that seminal fluid has long been underutilized in the field of oncology, despite its biological richness and proximity to the prostate gland. “These studies show that seminal fluid holds untapped diagnostic power,” she said. “We see mail-in semen analysis as a novel post-PSA reflex test that can prevent unnecessary biopsies and help focus healthcare resources on patients who truly need intervention.”
Modernizing Post-Vasectomy Care with Mail-In Testing
In addition to the prostate cancer research, Fellow Health is also unveiling new data supporting the clinical reliability of its mail-in PVSA service. For men who have undergone vasectomy, PVSA is a routine test used to confirm the absence of sperm in ejaculate—a key indicator of successful sterilization. However, traditional PVSA typically requires an in-person clinic visit, which many patients delay or avoid due to logistical constraints, embarrassment, or scheduling conflicts.
To address these barriers, Fellow Health developed a mail-in PVSA kit that allows patients to collect semen samples at home and ship them to a certified laboratory using a proprietary preservative that stabilizes sperm cells during transit. The AUA 2025 presentations will include two studies validating the effectiveness of this approach in real-world and laboratory conditions.
In the first study, researchers assessed the stability of sperm samples preserved in Fellow Health’s proprietary medium over a 10-day period. The results demonstrated that sample integrity remained high throughout the testing window, allowing for accurate analysis even when delays occurred during shipping.
In a second real-world performance study, the researchers compared the retest rate of mail-in samples to that of fresh samples analyzed immediately after in-clinic collection. The retest rate for mail-in PVSA was only 4.2% higher than fresh sample testing—an encouraging outcome that affirms the reliability of the mail-in approach for most patients.
“Equity in men’s reproductive health starts with meeting people where they are,” said James F. Smith, MD, MS, Chief Medical Officer and New York State 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 reproductive healthcare, regardless of his personal or geographic circumstances.”
Smith also emphasized the public health implications of increasing PVSA compliance through remote testing. “Vasectomy is one of the most effective forms of contraception, but its success depends on follow-up semen testing,” he explained. “Our goal is to make that follow-up as seamless and accessible as possible, which in turn helps ensure long-term family planning success for the patients we serve.”
A New Era for Patient-Centered Urologic Diagnostics
The presentation of these studies at AUA 2025 marks an important milestone for Fellow Health as it continues to pioneer the development of mail-in diagnostic solutions tailored to the unique needs of men’s health. With strong clinical performance data and growing acceptance among patients and providers, the company’s solutions stand to reshape how urologic conditions are diagnosed, monitored, and managed.
Fellow Health’s research not only opens the door to more personalized and non-invasive prostate cancer screening but also empowers more men to complete essential post-vasectomy follow-ups without sacrificing privacy or convenience. These advances are especially critical at a time when healthcare systems are increasingly emphasizing accessibility, preventative care, and cost-effectiveness.
“Our mission is to reimagine male reproductive health by putting patients at the center of every diagnostic journey,” Clark-Langone concluded. “From prostate cancer screening to PVSA, our research demonstrates that innovative technologies can deliver meaningful improvements in care—without requiring men to step outside their homes.”
As awareness of men’s health continues to grow, Fellow Health is positioning itself at the forefront of this evolution with tools designed not only for clinical accuracy but also for human-centered care. The AUA 2025 meeting provides a timely platform for the company to share its vision—and its data—with the broader urology and healthcare community.
