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NewsNewsLegacy, North America's leading digital male fertility clinic, has secured New York State CLEP approval for both its semen analysis and DNA fragmentation test – the only mandatory pre-market laboratory review programme in the United States. The approvals confirm clinical-grade validity for at-home samples, extending access to New York patients without a clinic visit.
Legacy, a leading male fertility testing and sperm preservation company, has announced that the New York State Department of Health's Clinical Laboratory Evaluation Program (CLEP), administered by the Wadsworth Center, has formally validated and approved two of its laboratory-developed tests: semen analysis and sperm DNA fragmentation analysis.
The milestone places Legacy in rare company. New York operates the only programme in the United States that requires each laboratory-developed test (LDT) to clear a formal, mandatory pre-market review before being offered to patients in the state. Clearing that bar for a single test is a significant achievement. Clearing it for both core andrology assays simultaneously, semen analysis and the DNA fragmentation test, is a statement about the clinical rigour behind Legacy's entire testing platform.
Most US states do not require laboratory-developed tests to undergo pre-market regulatory scrutiny before reaching patients. New York's CLEP programme is the exception – a system that mandates independent validation of each LDT's methodology, analytical performance, and clinical applicability before results from that test can be reported to patients in the state.
For Legacy, which built its model around at-home sample collection and mail-in delivery to its CLIA-certified andrology laboratory in New Jersey, obtaining CLEP approval for tests performed on home-collected samples carries particular weight. Both approved tests are validated specifically for use on samples collected at home and returned to Legacy's laboratory – not clinic-collected samples operating under controlled conditions but real-world specimens handled by patients themselves.
"New York is arguably the most rigorous state-based evaluation of laboratory testing methodology in the country," said Dr. Scott Lundy, Chief Medical Officer of Legacy. "Obtaining certification for both semen analysis and DNA fragmentation reaffirms our commitment to clinical excellence and provides strong evidence of the clinical validity of our at-home test relative to the gold standard."
The two CLEP-approved assays sit at the heart of Legacy's clinical offering – and together, they cover complementary dimensions of male reproductive health.
Semen Analysis evaluates the core parameters of sperm function:
The DNA Fragmentation Test goes a critical step further. Where standard semen analysis evaluates physical sperm parameters, the DNA fragmentation test measures the integrity of the genetic material that sperm carries, a dimension of sperm health that standard analysis does not capture and that can be elevated even in men whose routine semen parameters appear normal.
Sperm DNA fragmentation refers to breaks or damage in the DNA strands within individual sperm cells. High levels have been associated with male infertility, recurrent pregnancy loss, and poor IVF outcomes. For patients and clinicians attempting to understand why conception or IVF is failing despite apparently normal semen parameters, the DNA fragmentation test provides a layer of diagnostic insight that standard analysis simply cannot.
Together, the two CLEP-approved tests give New York patients and their physicians a genuinely comprehensive picture of male fertility, one derived from a sample collected at home, without a clinic visit.
For patients in New York, the approvals remove a barrier that has existed since Legacy began expanding its at-home testing platform. CLEP approval means that results from Legacy's semen analysis and DNA fragmentation test can now be formally reported to patients in New York State – with the backing of the country's most demanding independent LDT review process.
Khaled Kteily, founder and CEO of Legacy, put it plainly:
"New York sets the highest bar in the country for laboratory testing, and clearing its review for an individual test is its own milestone. Having both our semen analysis and DNA fragmentation tests approved means a New Yorker can get a clinical-grade result without leaving home and trust that it has been validated against the most rigorous standard that exists. That's the kind of access we've spent years building toward."
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