NEW YORK (GenomeWeb News) – CombiMatrix said today that its chromosomal microarray test for miscarriage analysis has received conditional approval from the New York State's Department of Health, allowing the company to begin testing patient samples from the state.
"Gaining the conditional license and ultimately the final approval to market and sell our [Product of Conception] test throughout New York is an important milestone for us that will allow us to broaden the market for our number one growth product," CEO Mark McDonough said in a statement.
"As approved under the conditional license, we will now begin to sell directly to customers and to seek distribution partnerships to leverage our internal sales force. This could be a tremendous opportunity for us and, we believe, for the physicians and patients in New York," he added.
The POC test is the Irvine, Calif.-based firm's fastest growing test based on volume, and following the publication of a study in the New England Journal of Medicine in December indicating chromosomal microarrays can provide more clinically relevant information than traditional karyotyping, as reported by BioArray News, sales of the firm's two chromosomal microarray analysis tests have increased "significantly," CombiMatrix said recently.
The announcement follows a deal last week under which Pathology selected CombiMatrix to be the exclusive provider of Pathology's chromosomal microarray tests for the POC testing market in the US.