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ONCALERT®:
THE SCIENCE OF EARLIER®
THE FIRST AND ONLY TESTS TO IDENTIFY A TUMOR-INITIATING AND STEM CELL-ASSOCIATED BIOMARKER FOR ORAL CANCER
The OncAlertTM Oral Cancer RAPID Test and OncAlertTM Oral Cancer LAB Test are technologically advanced and highly accurate methods to aid in the early detection of oral cancer through the unprecedented detection of CD44 and total protein levels collected in an oral rinse.
CD44 is significantly overexpressed in oral cancer even in early stages.
AID IN DIAGNOSTIC DECISION. The qualitative biomarker assay (OncAlert RAPID), with a negative predictive value (NPV) of 92%†, performs well in ruling out oral / oropharyngeal cancer when a reasonable suspicion exists.
COMPARISON OVERVIEW
AID IN DIAGNOSIS. OncAlert LAB, a quantitative algorithm which incorporates clinical variables with biomarker levels, provides better discrimination of cancer vs. benign processes, ruling in suspicious lesions.
*Optimal independent sensitivity and specificity with observed performance ranges
**Macey R, Walsh RT, Brocklehurst P, et al. Diagnostic tests for oral cancer and potentially malignant disorders in patients presenting with clinically evident lesions. (Review). Cochrane Database of Systematic Reviews. 2015, Issue 5. The Cochrane Collaboration.
***Challenges when comparing testing approaches include overall cohort composition and heterogeneity of disease under investigation. In the Macey et al. 2015 review, prevalence ranged from 4-97% across all studies (median range: .20-50%) and there was additional heterogeneity in the eligibility criteria used, which makes a direct comparison more problematic.
Summary Note: None of the adjunctive tests can be recommended as a replacement for the currently used standard of a scalpel biopsy and histological assessment.
†With 95% CI of 84% - 96%
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