NEW YORK (GenomeWeb News) – DiagnoCure has received a Clinical Laboratory Permit from New York State regulators for its CLIA-approved and CAP-certified laboratory, the company announced today.
The permit from the New York State Department of Health allows DiagnoCure's lab in West Chester, Penn., to use the company's Previstage GCC Colorectal Staging Test on commercial samples originating in New York, which could crack open a significant market for the test, DiagnoCure said in a statement.
Citing the American Cancer Society, the company said that New York has the third-highest rate of new colorectal cancer cases among states in the US.
"This license, coupled with the rollout of our colorectal cancer disease management program, is a considerable milestone in bringing our proprietary Previstage GCC test to colorectal specialists nationwide," said Valerie Palmieri, president of DiagnoCure Oncology Laboratories, in the company's statement.
She added the test is the only molecular test available to help better identify whether colorectal cancer has spread to the lymph nodes. The test received CLIA certification in 2008. In New York State, however, a CLIA-approved test must also receive clearance from state regulators for use.