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Vigilant Biosciences Inc, Fort Lauderdale, Fla, has launched patient enrollment for clinical studies of its OncAlert point-of-care qualitative assay in support of its premarket regulatory submission to FDA.

Oral and throat cancers can be life-threatening, and their frequency seems to be increasing. Now, two tests that are simple, painless and noninvasive can often detect them at very early stages when they can often be treated successfully.

Fort Lauderdale-based Vigilant Biosciences, which has developed dental and lab toolkits for early detection of oral cancer, has been awarded part of a multi-million dollar grant for a study from the National Institutes of Health.

Vigilant Biosciences has initiated a US FDA clinical study, with plans to recruit up to 1,000 patients, of its OncAlert point-of-care oral cancer risk assessment test.

The OncAlert oral cancer product line from Vigilant Biosciences Inc., Fort Lauderdale, Fla, includes the OncAlert oral cancer rapid test and the OncAlert oral cancer lab test, available in countries accepting CE mark.

Oral cancer – including cancers of the mouth and throat – is an area that is attracting new attention from the diagnostic community – this time with the help of dentists.

Vigilant Biosciences has launched patient enrollment for clinical studies of its OncAlert point-of-care qualitative assay in support of its registration submission to the Food and Drug Administration (FDA).

Nearly 50,000 people are diagnosed with oral cancer in the U.S. each year—and that number continues to grow, particularly among certain segments of the population.

More than 49,750 people in the United States will be diagnosed with oral cancer this year, according to Vigilant Biosciences. Yet 62% of adults in the US know very little or nothing at all about the disease—including cancer of the oral cavity, tongue, larynx, and pharynx—and only 29% report being screened for oral cancer at their last dental checkup.

Vigilant Biosciences’ CEO Matthew H.J. Kim offers insight surrounding the link between HPV and oral cancer.

In the United States, awareness and education surrounding oral cancer is low. In observance of National Oral Cancer Awareness Month and Oral, Head and Neck Cancer Awareness Week this April, Vigilant Biosciences joined with the Head and Neck Cancer Alliance, the Oral Cancer Foundation, and Support for People with Oral and Head and Neck Cancer to launch a campaign to raise awareness about oral cancer and its risk factors.

Vigilant Biosciences’ Scientific Co-Founder and Chief Scientific Officer Elizabeth Franzmann, M.D., recently caught up with WPLG to discuss oral cancer and the Company’s OncAlert Oral Cancer product line.