NEW YORK (GenomeWeb) – CombiMatrix announced today that it has received conditional approval from the New York State Department of Health to market its CombiSNP chromosomal microarray analysis test for pediatric development disorders.
By gaining conditional approval, CombiMatrix will be able to market the test in New York while the assay is under Clinical Laboratory Reference System review. Upon completion of the review, either the test will receive full approval or additional information will be required in order to achieve final approval, the company said.
"We have focused our market development activities on our miscarriage analysis test over the past year and now we plan to expand our activity to address pediatric disorders," CombiMatrix CEO Mark McDonough said in a statement.
The New York State Department of Health granted CombiMatrix conditional approval last year to market its CombiSNP CMA test for miscarriage analysis.
CombiMatrix's tests are offered through its CLIA-compliant lab in Irvine, Calif.