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Vigilant Biosciences Announces the Launch of the OncAlert Labs OraMark Test

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First Quantitative Laboratory Developed Test to Accurately Measure a Tumor-Initiating and Stem Cell Associated Biomarker for Head and Neck Cancer in an Oral Rinse
Posted: June 1, 2016
Edited by Dentaltown staff

FORT LAUDERDALE, Fla. and CHICAGO—Vigilant Biosciences has announced the launch of the OncAlert Labs OraMark Test, a quantitative oral rinse test to accurately measure a tumor-initiating and stem cell associated biomarker for oral cancer detection at its earliest stages.

The OraMark test will be available to clinicians in the U.S. as a laboratory developed test beginning in second half of 2016 exclusively through OncAlert Labs, a CLIA-certified laboratory and a Vigilant Biosciences affiliated company.

Vigilant Biosciences will debut OraMark in Booth #24100 at the American Society of Clinical Oncology 2016 Annual Meeting, taking place in Chicago from June 3 - 7, 2016.

OraMark is based on patented technology, including a methodology for measuring the tumor-initiating and stem cell associated biomarker CD44 in combination with total protein, enabling earlier and more accurate detection of oral cancer even potentially before visual indicators.

The test provides highly-actionable information pre- and post-biopsy, which complements visual examination and other tools used by head and neck specialists for detecting oral cancer to help optimize patient management and surveillance.

"The launch of OraMark is a major milestone for our company as it represents our first product available in the U.S. aiding clinicians with actionable information in the early detection of oral cancer with a quantitative oral rinse test," said Matthew H.J. Kim, founder, chairman, and CEO of Vigilant Biosciences. "We are thrilled to be making our U.S. debut of the OncAlert Labs OraMark test at ASCO and look forward to launching the test later this year while continuing to expand our product line and distribution channels both in the U.S. and internationally."

OraMark science leverages more than a decade of clinical research conducted by Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine.

"The OraMark test is unique in that it is a quantitative test that provides supportive information to clinicians who specialize in diagnosing and treating oral cancer, aiding them in deciphering the complex presentation of patients who may have non-specific oral cancer symptoms or other risk factors for oral cancer," said Michael J. Donovan, Ph.D., M.D., chief clinical officer of Vigilant Biosciences. "The proprietary technology behind OraMark measures biomarkers that are known to indicate an elevated risk for oral cancer and has the potential, with continued clinical validation, to lead to more successful outcomes from this deadly disease."

OraMark tests an easy-to-collect oral rinse that is sent to OncAlert Labs for analysis. The cost-effective test is easy to administer, non-invasive for the patient, and provides easy-to-interpret results for clinicians.

Additionally, Vigilant Biosciences announced ASCO selected its abstract, Oral Rinse Test as a Diagnostic Aid for Oral Cancer, for online publication in conjunction with the 2016 ASCO Annual Meeting. The abstract reported the results of a study demonstrating the association of salivary CD44 and total protein levels with oral cavity and oropharyngeal cancer while also validating previously set cut points for those biomarkers. The research was conducted in support of the Company's CE registered OncAlert Oral Cancer LAB Test available in select European markets. The abstract is available on asco.org and jco.ascopubs.org.

The OraMark Test is only available in the U.S. exclusively through OncAlert Labs. For more information, visit vigilantbiosciences.com and oncalertlabs.com.
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