NEW YORK (GenomeWeb) – Celmatix's multi-gene panel test for reproductive health conditions, Fertilome, has been approved by New York State's Department of Health as a laboratory-developed test, the firm said today.
Fertilome is a blood-based assay that analyzes 49 DNA variants in 32 genes that are associated with women's reproductive health conditions, such as endometriosis, polycystic ovarian syndrome, recurrent pregnancy loss, and early menopause. The company launched the test from its CLIA-certified laboratory in New York in January through a pre-approval program administered by the state.
"The stringent criteria for approval in New York State serves as a guidepost for clinical laboratories across the country, and having achieved this approval is a strong validation of the science and methodology behind our groundbreaking test," Lesley Northrop, clinical laboratory director of Celmatix Clinical Laboratories, said in a statement.
Celmatix CEO Piraye Yurttas Beim said that the firm wanted to launch the test in New York, which has stringent requirements for LDTs, in order to demonstrate that it had both clinical validity and clinical utility. "We are very sensitive to the emotional and financial burdens on women considering egg freezing or undergoing fertility treatments," Beim added.