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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. 

Current Research

Oral Cancer (Oral Squamous Cell Carcinoma)

Salivary mRNA and protein markers for the detection of oral squamous cell carcinoma were initially identified in discovery work performed by Dr. David Wong and colleagues at UCLA. These markers were then further studied in additional multiethnic cohorts in Serbia and India. As noted above, the National Cancer Institute – Early Detection Research Network also independently validated these markers in a cohort of 395 subjects. These mRNA markers were further validated in a rigorous prospective blinded fashion by PeriRx in collaboration with Delta Dental and several academic medical centers in Michigan. The mRNA markers that are the basis for the SaliMarkTM OSCC test have now been studied in trials that include over 800 subjects. Ongoing clinical studies are continuing on these biomarker panels in an effort to always ensure the optimal implementation in clinical practice.

Lung Cancer

Biomarkers for the detection of non-small cell lung cancer were identified in discovery studies at UCLA. PeriRx has recently launched a multicenter prospective blinded validation trial for these discriminatory markers. Patients with suspicious lung lesions detected on CT scan will have saliva collected before clinically driven tissue biopsy. Biomarkers will be evaluated by laboratory personnel blinded to the tissue diagnosis. These markers are intended to be used to identify at-risk subjects most in need of CT scanning. Given the known high rate of false positive CT scans, these markers are also intended as an aid in the decision on proceeding to biopsy in patients with abnormal lung scans.

Sjogren’s Syndrome

Prior studies have identified mRNA, protein and antibody markers in saliva that are highly discriminatory for primary Sjogren’s syndrome. These markers were subsequently pre-validated in a study in the Netherlands and optimal multi-marker discriminatory panels were identified. In collaboration with the Sjogren’s Syndrome Foundation, PeriRx has launched a United States validation trial for these marker panels.

Type 2 Diabetes and Pre-Diabetes

Initial prospective blinded discovery studies have identified candidate salivary biomarker panels for the detection of type 2 diabetes and for the early detection of pre-diabetes and insulin resistance. This work was accomplished in a collaboration with Dr. David Wong at UCLA and Dr. Kaumudi Joshipura at the Center for Clinical Research and Health Promotion at the University of Puerto Rico School of Dental Medicine. These patients were from a larger 1,600 patient prospective longitudinal trial in a high risk Hispanic population that will allow for further validation. PeriRx is collaborating with these groups to further refine these panels in preparation for a multiethnic US validation trial.

These markers are initially intended to be used as a convenient noninvasive tool for the early detection of a disease that often goes unrecognized until life threatening end organ damage has developed. This could be utilized in primary care and dental offices. Of note is the fact that prior studies have documented the high incidence of undiagnosed pre-diabetes and diabetes in general dental practices and many of these patients see their dentist more frequently than a medical doctor.

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