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.
Headquartered in Hong Kong with ISO 13485 accredited Quality Management System, DiagCor has been dedicated solely to molecular diagnostics (MDx) since 2006. The global leader in flow-through hybridization technology, the company offers a range of products, solutions and services related to RNA and DNA analysis. As well as providing MDx laboratory services to Asia Pacific practitioners, DiagCor develops and manufactures MDx products and solutions, and offers MDx medical translation services and MDx consulting.