By Apex360 Editors

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

Vigilant Biosciences Inc. (Fort Lauderdale, Florida), a developer of solutions that aid in the early detection and intervention of cancer, last week announced the launch of the OncAlert Labs OraMark Test, the first 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 United States as a laboratory-developed test beginning in second half of 2016 exclusively through OncAlert Labs LLC, a CLIA-certified laboratory and a Vigilant Biosciences–affiliated company.

Vigilant Biosciences is debuting OraMark at the American Society of Clinical Oncology (ASCO) 2016 Annual Meeting, currently taking place in Chicago.

CD44 Biomarker

OraMark is based on patented technology, including an innovative 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 optimise patient management and surveillance.

First-Available Product in United States

“The launch of OraMark is a major milestone for our company,” said Matthew H.J. Kim, founder, chairman, and CEO of Vigilant Biosciences. “[It] represents our first product available in the US aiding clinicians with actionable information in the early detection of oral cancer with a quantitative oral rinse test.”

Kim added, “We are thrilled to be making our US 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 US and internationally.”

Clinical Research

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, PhD, MD, 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.

Related Technology

Vigilant Biosciences’ product offerings also include the OncAlert Oral Cancer product line, which is CE Marked and available for sale in select international markets. The OncAlert Oral Cancer product line includes the OncAlert Oral Cancer RAPID Test and the OncAlert Oral Cancer LAB Test. Both products measure soluble CD44 and total protein levels—protein markers clinically validated to be associated specifically with oral cancer when measured in an oral rinse—aiding clinicians in the early detection and intervention of oral cancer.

Both products use a simple, oral rinse collection and measurement procedure that is easy to administer and non-invasive for the patient. The accurate, cost-effective tests can benefit every adult, with particular emphasis on high-risk populations (i.e., current and former tobacco users, those who consume excessive alcohol, and people with human papillomavirus HPV-16). The OncAlert Oral Cancer product line is not yet available for sale in the US.

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 at asco.org and ascopubs.org. 

About Oral Cancer

According to a Vigilant Biosciences press release, there are more than 600,000 new cases of oral cancer each year worldwide. More than 48,000 individuals estimated in the United States alone will be diagnosed with oral or oropharyngeal cancer this year with close to 9,600 deaths resulting from this disease, killing roughly one person per hour, 24 hours a day.

Worldwide, the mortality rates reach up to an estimated 360,000 deaths each year. Historically the death rate associated with this cancer is particularly high due to late-stage diagnosis and intervention. Currently, the vast majority of patients are detected through a visual exam and/or are symptomatic, at which point they are likely late stage. As a result, oral cancer often goes undetected to the point of metastasizing. Early diagnosis of oral cancer results in a cure rate of up to 90 percent.