23 Dec 2013 [Press release]

New York Approves Natera’s CLIA Laboratory

NEW YORK (GENOMEWEB NEWS) — Natera today announced that New York has issued a permit for the company’s CLIA laboratory, allowing Natera to offer its preconception and prenatal tests to expecting parents in the state. 

The New York State Department of Health issued a clinical laboratory permit for the company’s CLIA-certified laboratory in San Carlos, Calif. Approval includes Natera’s Panorama non-invasive prenatal test for fetal aneuploidies, the firm said.

The test, launched earlier this year, uses a blood draw to detect trisomy 21, 18, and 13, as well as monosomy X, triploidy, and sex chromosome aneuploidies. It employs Natera’s algorithm called Next Generation Aneuploidy Testing Using SNPs to analyze cell-free DNA from both the mother and the fetus. 

Natera last week announced an agreement with DiagCor to bring Panorama to Hong Kong. It has deals with Quest Diagnostics, Bio-Reference Laboratories, and Arup Laboratories to offer its test in the US.