Legacy Receives New York State CLEP Approval for Two Laboratory-Developed Tests: Semen Analysis and DNA Fragmentation

Legacy clears New York's stringent pre-market review of laboratory-developed tests for both of its core andrology assays, semen analysis and DNA fragmentation analysis.

NEW YORK, June 24, 2026 /PRNewswire/ -- Legacy, a leading male fertility testing and sperm preservation company, today announced that the New York State Department of Health's Clinical Laboratory Evaluation Program (CLEP), administered by the Wadsworth Center, has validated and approved two of its laboratory-developed tests: semen analysis and sperm DNA fragmentation analysis.

New York operates the only program in the United States that requires each laboratory-developed test (LDT) to clear formal, pre-market review. Unlike standard federal certification, which governs how a laboratory operates, this test-level review evaluates the validity of the test methodology itself. The Centers for Medicare & Medicaid Services recognizes New York's standards as equal to or more stringent than federal CLIA requirements. With these approvals, both of Legacy's tests, performed using computer-assisted sperm analysis (CASA) technology, have cleared that review.

Both approved tests are validated for use on samples collected at home and returned to Legacy's laboratory. Legacy's semen analysis provides a clinical assessment of core sperm parameters, while its DNA fragmentation test measures the integrity of the genetic material carried by sperm, an increasingly important marker in fertility evaluation. Together, the two give New York patients and their physicians a comprehensive picture of male fertility from an at-home sample.

"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. For New York patients and the physicians who care for them, this is strong reassurance that the platform and its results can be trusted."

"New York sets the highest bar in the country for laboratory testing, and clearing its review for an individual test is its own milestone," agrees Khaled Kteily, founder and CEO of Legacy. "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."

About Legacy

Legacy is a leading male fertility clinic in the United States, offering at-home semen analysis, sperm cryopreservation, and post-vasectomy testing. With a CLIA-certified, high-complexity andrology lab and one of the largest proprietary datasets in male reproductive health, Legacy is advancing access, data, and innovation in fertility care.

Important Information

Legacy's semen analysis and DNA fragmentation testing is a laboratory-developed test reviewed and approved by the New York State Department of Health for use on New York specimens. New York State's approval applies to the laboratory test itself. It does not constitute review or approval of any specimen collection device used in connection with the test, nor of any artificial intelligence or machine learning–based software used in the development or performance of the test. Patient reports include information on the limitations of the assay.

SOURCE Give Legacy, Inc.