Legacy Received New York State CLEP Approval for Two Laboratory-Developed Tests: Semen Analysis and DNA Fragmentation
On 24 June 2026, Legacy announced that the New York State Department of Health's Clinical Laboratory Evaluation Program (CLEP), administered by the Wadsworth Center, had validated and approved its laboratory-developed semen analysis and sperm DNA fragmentation analysis tests. The approvals marked a significant milestone as New York's rigorous pre-market review process evaluates the validity of individual laboratory-developed tests beyond standard federal laboratory certification requirements. Both tests, which utilize computer-assisted sperm analysi...