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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. 

SaliMark-Branded Box with Report

PeriRx’s first product is SaliMark™ OSCC – A risk stratification test recommended for use by the clinician when suspicious lesions are observed and additional testing is warranted.

These discriminatory salivary biomarkers have been clinically-validated in multiple large trials including studies in collaboration with the National Cancer Institute and with premiere US academic medical centers such as the University of Michigan, Michigan State University and the Providence Health System in Detroit.

SaliMark™ OSCC Saliva Test Kit consist of two components:

  1. The sample collection kit
  2. The lab assay

The salivary sample collection kit is used to collect the specimen in the clinical office setting. The sample will be sent via pre-paid overnight service to the scientific testing lab where a specific lab assay will be performed. The test results will be made available to the clinician, electronically consistent with HIPAA compliant protocols within 72 hours.

The lab assay tests for elevation of certain combinations of biomarkers present in the saliva, which are consistent with an increased risk for the presence of oral cancer. Based on the lab results a risk probability determination will be provided in a report to the clinician for patient follow-up.

Directions for SaliMark™ OSCC Oral Cancer Salivary Diagnostic Test

  1. Perform a thorough oral exam
  2. Oral exam identifies a potential suspicious lesion
  3. Discuss with the patient the role of the salivary test to quantitate risk
  4. Have the patient rinse their mouth
  5. Collect 2 cc of saliva (not sputum) in the specialized collection tube
  6. Identify the sample with the provided label including the patient name and birthday
  7. Fill in the Requisition Form and mail the form with sample NEW OSCC REQUISITION FORM
  8. Seal and ship by Prepaid FedEx to the laboratory for analysis
  9. Log into the HIPAA secure site to obtain results within 3 days
  10. For low risk test schedule follow up to insure resolution
  11. For high and moderate test scores the patient should be referred to an oral cancer specialist for further evaluation and consideration of biopsy