Noninvasive colorectal cancer (CRC) screening test developer Geneoscopy has received a laboratory permit from the New York State Department of Health (NYSDOH).
Receiving the permit marks a milestone in making Geneoscopy's multitarget stool-based RNA screening test available nationwide, Geneoscopy's senior vice president of quality assurance and regulatory affairs Julie LaRocca said in a news release.
In an email to LabPulse.com, LaRocca said Geneoscopy is a CAP/CLIA-accredited lab. Most states rely on CAP/CLIA to provide services. However, Geneoscopy has obtained additional licenses required by specific states that have established their own processes to meet their specific needs (California, Maryland, New York, Pennsylvania, Rhode Island, and the District of Columbia) to perform testing "out of state" at Geneoscopy's laboratory in St. Louis.
"Receiving the NYSDOH permit was the final state-specific permit requirement, allowing us to provide our services nationwide in all states and DC," the email stated.
ColoSense is indicated as a screening test for adults, age 45 or older who have an average risk of developing CRC. The U.S. Food and Drug Administration (FDA) cleared the test in May.
In its approval letter to Geneoscopy, the FDA stated that the company must conduct a study to expand the total number of CRC cases evaluated by Colosense. The postapproval studies program includes a prospective, multisite, decentralized study evaluating the sensitivity and specificity of Colosense, using colonoscopy as the reference method. Lesions will be confirmed as malignant by histopathologic examination.
ColoSense is intended for the qualitative detection of colorectal neoplasia-associated RNA markers and the presence of occult hemoglobin in human stool, according to information filed with the FDA. A positive ColoSense result may indicate the presence of CRC, advanced adenomas, or serrated precancerous lesions. The IVD test is designed to be used with the ColoSense Collection Kit, the ColoSense Test Kit, the ColoSense Software, as well as the Polymedco iFOBT Analyzer; the bioMérieux EMAG Nucleic Acid Extraction System, and Bio-Rad's QXDx ddPCR System.
All clinical and forensic laboratories and blood banks located in or accepting specimens from New York must hold a state clinical laboratory permit issued through the Clinical Laboratory Evaluation Program, or CLEP. This includes laboratories performing tests on specimens from clinical trial participants for participant management under Institutional Review Board-approved research or clinical trial protocols, where the results are reported and are used for clinical decision-making, according to the NYSDOH.
