PeriRx has launched its SaliMark OSCC salivary DNA test for oral cancer at a continuing education event on Thursday in Havertown, PA, and also plans to introduce the test at the upcoming Greater New York Dental Meeting, held in New York City from November 28 to December 3, according to a bizjournals.com story.
SaliMark can be used in dental offices to detect early-stage oral cancer from a small amount of saliva, and clinical tests have shown the test to have a sensitivity of 95%, according to the company. The company's biomarkers have been clinically validated in multiple large trials, including studies done in collaboration with the National Cancer Institute. The test involves a patient spitting into a tube, which is sealed and sent to PeriRx for lab analysis.
SaliMark will be initially introduced as a Food and Drug Administration (FDA) Clinical Laboratory Improvement Amendment (CLIA)-approved test, meaning it can be marketed under the CLIA regulations that govern laboratory-based tests. PeriRx is continuing clinical testing of SaliMark to get FDA clearance to market it more broadly.
The kits will sell for $20, and the test will cost $145. PeriRx is working with Delta Dental and UnitedHealthcare to obtain reimbursement codes that will allow dentists to bill the insurers directly for the diagnostic test. Until the separate codes are secured, dentists will be able to add the screening to existing procedure codes.
PeriRx has also formed a partnership with Henry Schein and Patterson Dental to market the test kits directly to dentists.
