Ariosa's prenatal test gains crucial New York lab licensing certification

Ariosa's Harmony prenatal test--Courtesy of Ariosa Diagnostics

Ariosa Diagnostics won New York certification to start marketing its Harmony prenatal test to providers in the state, beginning a second year of an aggressive push to grab market share.

Specifically, the San Jose, CA, company said it gained approval from the New York Department of Health's Division of Laboratory Quality Certification to begin selling Harmony and reporting test results to New York healthcare providers. Ariosa notes that New York reported more than 362,000 pregnancies in 2011. While the company certainly won't reach every pregnant patient, even a portion of that annual population would represent a large market-growth opportunity for the molecular diagnostic.

Ariosa launched in 2008. Harmony, its signature product, is a precise blood test designed to assess the risk of Down syndrome and other fetal chromosomal conditions. It is one of many competitors in the space, going against rivals including Sequenom ($SQNM), Natera and Illumina's ($ILMN) Verinata Health.

Ariosa exists in a reality where diagnostic companies often struggle to make an impact in the marketplace after developing a test, considering that providers don't often shift easily from current standards of care. Additionally, both federal and state reimbursement, as well as a myriad of state regulations, can be hard to obtain and navigate, respectively. New York's laboratory quality standards are quite rigorous, so the milestone ends up being an advertising tool as Ariosa pursues further growth and seeks more customers.

Ariosa has worked hard to expand interest in Harmony. Last December, Ariosa touted two new clinical studies showing that Harmony worked well in assessing the risk of Down syndrome in twin pregnancies. Last fall, the company, along with Natera and Verinata, scored major deals to provide diagnostic testing to California's women through the state's prenatal testing program. Perhaps its biggest victory so far came in October, when it defeated rival Sequenom in a prenatal testing patent battle that could have derailed Harmony.

- read the release

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