Key Takeaways
- • Fellow Health is adding sperm DNA fragmentation testing to its mail-in testing portfolio, alongside its semen analysis service, with clinic availability expected before the end of 2026 in every state except New York.
- • The test was introduced at the American Society for Reproductive Medicine (ASRM) 2026 Scientific Congress & Expo and measures breaks in sperm genetic material that standard semen parameters do not capture.
- • The move follows ASRM's 2026 update to its committee opinion on recurrent pregnancy loss, the first since 2012, which states DNA fragmentation testing may be considered for otherwise unexplained recurrent miscarriage or recurrent miscarriage with infertility.
- • Fellow Health reports its semen analysis is used by more than 4,000 fertility and urology practices and that more than 300,000 men have been tested through the company.
Summary
Fellow Health, a San Leandro, California-based company focused on male reproductive health, announced it is adding sperm DNA fragmentation testing to its mail-in portfolio, according to a Business Wire release. Clinicians will be able to assess sperm DNA integrity with the same at-home, mail-in process used for the company's semen analysis. The test was introduced at the ASRM 2026 Scientific Congress & Expo, and Fellow Health expects to make it available to clinics in every state except New York before the end of 2026.
The launch aligns with ASRM's 2026 update to its committee opinion on recurrent pregnancy loss, the first revision since 2012. The updated guidance states that sperm DNA fragmentation testing may be considered for otherwise unexplained recurrent miscarriage, or for recurrent miscarriage accompanied by infertility. According to the release, elevated fragmentation can occur even when standard semen parameters are normal, potentially leaving a contributing factor to infertility undetected. Higher fragmentation has been associated with reduced chances of natural conception and increased risk of pregnancy loss. Oxidative stress is identified as a major contributor to sperm DNA damage, with risk factors including age, varicocele, infection, smoking, obesity, heat exposure and environmental toxins.
James F. Smith, MD, MS, Chief Medical Officer and NYS Laboratory Director at Fellow Health, said that a normal semen analysis can leave couples without an explanation for repeated pregnancy losses or unsuccessful fertility treatment, and that the test can inform a more focused evaluation for selected patients. Chief Executive Brian Hogan said the company is building the test into its validated mail-in process so clinicians can investigate beyond standard semen parameters and reach answers sooner.
The company, founded in 2018, reports that it partners with more than 4,000 fertility and urology practices, processes over 450 patient samples daily through its CLIA-certified lab, and has supported more than 60 abstracts and peer-reviewed studies. Fellow Health has received funding from investors including 5AM Ventures, Forest Road, Labcorp Venture Fund, Human Capital, Genoa Ventures and Mantis Venture Capital. The release does not disclose pricing or financial terms for the new test.
The launch aligns with ASRM's 2026 update to its committee opinion on recurrent pregnancy loss, the first revision since 2012. The updated guidance states that sperm DNA fragmentation testing may be considered for otherwise unexplained recurrent miscarriage, or for recurrent miscarriage accompanied by infertility. According to the release, elevated fragmentation can occur even when standard semen parameters are normal, potentially leaving a contributing factor to infertility undetected. Higher fragmentation has been associated with reduced chances of natural conception and increased risk of pregnancy loss. Oxidative stress is identified as a major contributor to sperm DNA damage, with risk factors including age, varicocele, infection, smoking, obesity, heat exposure and environmental toxins.
James F. Smith, MD, MS, Chief Medical Officer and NYS Laboratory Director at Fellow Health, said that a normal semen analysis can leave couples without an explanation for repeated pregnancy losses or unsuccessful fertility treatment, and that the test can inform a more focused evaluation for selected patients. Chief Executive Brian Hogan said the company is building the test into its validated mail-in process so clinicians can investigate beyond standard semen parameters and reach answers sooner.
The company, founded in 2018, reports that it partners with more than 4,000 fertility and urology practices, processes over 450 patient samples daily through its CLIA-certified lab, and has supported more than 60 abstracts and peer-reviewed studies. Fellow Health has received funding from investors including 5AM Ventures, Forest Road, Labcorp Venture Fund, Human Capital, Genoa Ventures and Mantis Venture Capital. The release does not disclose pricing or financial terms for the new test.
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