CombiMatrix has received a clinical laboratory permit from the New York State Department of Health. The Irvine, Calif.-based molecular diagnostics firm can immediately begin receiving specimens from New York residents for its DNAarray postnatal developmental testing service, according to the firm's CEO.
Judd Jessup told BioArray News called the receipt of the permit an "important certification" that the firm can rely on when talking to potential clients." He added that the licensure gives CombiMatrix a "market advantage" over testing companies that lack one and therefore cannot service customers in New York.
While CombiMatrix's suite of array-based constitutional and oncology tests is offered via its US Clinical Laboratory Improvement Amendments-compliant lab, the firm has been unable to offer its services in states where more stringent standards for clinical testing supersede federally regulated CLIA standards without obtaining local certification.
The clearance comes roughly two years after New York informed CombiMatrix that it would require a state license to offer its array comparative genomic hybridization-based test. The firm had been offering the test to New Yorkers since it was launched in 2006.
Jessup said that CombiMatrix now hopes to recapture some of its customer base. "Since we were providing these tests to customers in the past, now that we are licensed we will be contacting them and seeking to regain their business," he said.
He added that the company will seek similar permits for its other tests both in the developmental and oncology segments of its business.
In addition to the New York permit, CombiMatrix has obtained clinical laboratory licenses "from all major states, including California, Florida, Pennsylvania, Maryland, and Rhode Island," in addition to its CLIA and College of American Pathologist accreditation.
According to its website, the firm's DNAarray Oligo 180K platform can be used to screen individuals for 260 developmental disorders caused by gains and losses of specific chromosomal regions, as well as more than 100 loci associated with autism spectrum disorders and 510 genes associated with congenital anomalies and developmental delays.