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New York State has a separate and unique regulatory approval process for laboratory diagnostic testing. PeriRx is currently in the application process with our SaliMark™ OSCC test and is vigorously committed to pursuing this application approval. 

Regulatory

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Diagnostic testing helps healthcare providers screen for or monitor specific diseases or conditions. It also helps assess patient health to make clinical decisions for patient care. The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certificated by their state as well as the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing.

Laboratories can obtain multiple types of CLIA certificates, based on the kinds of diagnostic tests they conduct. Three federal agencies are responsible for CLIA: The Food and Drug Administration (FDA), Center for Medicaid Services (CMS) and the Center for Disease Control (CDC). Each agency has a unique role in assuring quality laboratory testing. Click here for more informationPeriRx has a laboratory partner that is regulated by the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88) certification and affirms that its SaliMark™ molecular DNA tests are in compliance. Clinical assays used for these tests are clinically-validated for acceptable sensitivity and specificity results.