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Fellow Health Announces New York State Approval for Its Lab & Post-vasectomy Semen Analysis Kit

via Business Wire

Company Expands to Nationwide Availability with the Addition of Rigorous New York State License

Fellow Health, a leading company focused on advancing male reproductive health through patient-centric testing solutions, today announced that it received a high-complexity laboratory permit from the New York State Department of Health (NYSDOH) Clinical Laboratory Evaluation Program (CLEP) along with approval for its post-vasectomy semen analysis (PVSA). This milestone allows Fellow Health to offer its validated PVSA test in New York.

Roughly 500,000 vasectomies are performed in the U.S. each year, yet historically only 30-40% of patients complete the recommended post-procedure PVSA through traditional in-lab testing. These marginal compliance rates are typically only reached through resource-intensive clinic follow-ups. Fellow Health’s mail-in PVSA kit dramatically improves compliance rates without increasing provider burden, offering a more accessible and patient-friendly path to follow-up care.

The NYSDOH CLEP is recognized as having the most stringent laboratory oversight in the U.S., enforcing validation requirements that are equal to or more rigorous than federal CLIA standards. It oversees labs and laboratory-developed tests in New York State to ensure accuracy, reliability, and compliance with public health standards. As a high-complexity laboratory, Fellow Health operates under New York’s strictest regulatory framework, performing advanced diagnostic testing that demands specialized expertise, sophisticated equipment, and rigorous quality control measures.

“New York State’s comprehensive regulations ensure that only the highest quality tests reach patients, and we are proud to have met this standard,” said James F. Smith, MD, MS, Chief Medical Officer and NYS Laboratory Director at Fellow Health. “This approval is more than just a regulatory milestone—it’s a validation of our commitment to scientific excellence and exceeding industry benchmarks in clinical integrity.”

“Fellow Health being approved and available for post-vasectomy testing in New York is a big step forward for my patients,” said Joseph P. Alukal, MD, MBA, Associate Professor of Urology at Columbia University and Director of Men's Health at Columbia/NewYork-Presbyterian. “While vasectomy is one of the most reliable forms of contraception, failures can occur, which is why we recommend a confirmatory test after the procedure. Fellow Health’s PVSA helps patients in that they can do the test at home. For busy patients, this is a tremendous convenience. I am pleased to offer this to my vasectomy patients starting today.”

“More than 2,500 clinics, including 12 of the top 15 hospitals in the U.S., rely on Fellow Health because we’ve set a new standard for convenience and compliance in post-vasectomy testing,” said Brian Hogan, CEO of Fellow Health. “New York’s approval strengthens our position as the trusted choice for providers who want a clinically rigorous, patient-friendly alternative to traditional in-clinic testing.”

“I’m excited to offer Fellow Health’s mail-in semen analysis to our patients, making post-vasectomy testing more convenient and improving adherence to follow-up recommendations,” said Alexander Epelbaum, MD, FACS, MBA, Market President and Chairman of the Board at Integrated Medical Professionals, PLLC.

Fellow Health anticipates submitting its application to New York for its full semen analysis mail-in kit in the near future. The kit is currently available in other states.

About Fellow Health

Founded in 2018, Fellow Health is a leading company dedicated to advancing male reproductive health through innovative and comprehensive mail-in testing solutions. The company partners with more than 2,000 top clinical practices, processing over 400 patient samples daily through its CLIA-certified lab, and is the only mail-in semen analysis with peer-reviewed validation data. Fellow Health has secured funding from leading life sciences and technology investors, including 5AM Ventures, Forest Road, Labcorp Venture Fund, Human Capital, Genoa Ventures, and Mantis Venture Capital.

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