Vigilant Biosciences has struck a three-year deal with Crown Dental + Medical Limited to distribute the OncAlert Oral Cancer Risk Assessment System in New Zealand. The product includes the OncAlert Oral Cancer Rapid Point-of-Care Risk Assessment Test (OncAlert POC Test) and OncAlert Oral Cancer CD44 + Total Protein Lab Test (OncAlert LAB Assay).
Under the agreement, Crown Dental + Medical will exclusively market and sell the OncAlert POC Test and OncAlert LAB Assay to New Zealand’s dental and medical markets pursuant to the country’s regulatory approvals of the products, expected by the first quarter of 2016. Financial terms were not disclosed.
“The ability to assess the risk of oral cancer earlier, before it has progressed to a later stage, will help us save lives,” said Ross Gunn, director of Crown Dental + Medical Limited. “The system is easy to use and easy to integrate into a standard dental practice, making it a valuable new tool in our arsenal to fight this disease.”
The OncAlert POC Test and OncAlert LAB Assay are based on patented technology that detects specific protein markers known to indicate an elevated risk for oral cancer, even prior to the observation of visual or physical symptoms. They can be administered by dentists and hygienists alike. The companies also note that they can benefit every adult, particularly those with high risk of developing oral cancer, including current and former tobacco users, those who consume alcohol, and people with HPV. The products are currently under the CE Mark registration approval process.
Providers can use the OncAlert LAB Assay as an accurate, effective, and affordable quantitative risk assessment solution for clinicians involved in the diagnosis and treatment of oral cancer, according to Vigilant Biosciences. It involves an oral rinse that is expelled into a cup and sent to a laboratory for analysis. The painless test takes seconds to administer and is non-disruptive to the exam process.
The OncAlert POC Test is an accurate, effective, and affordable qualitative risk assessment solution for frontline screeners of oral cancer. It uses an oral rinse expelled into a cup. Then, the provider inserts a test device into a sample of the expelled rinse. Within minutes, the provider can read the results and apprise patients of their current level of risk for oral cancer.
In a study published in April, University of Auckland scientists revealed a “rapid rise” in diagnoses for oropharyngeal cancer in New Zealand men age 40 and older. Additionally, the New Zealand Ministry of Health notes that more than 600,000 people in the country use tobacco, and more than 550,000 are heavy drinkers — again, both key risk factors for oral cancer.
According to the World Health Organization, there are more than 600,000 new cases of head and neck cancer and 300,000 deaths each year worldwide. In the United States, more than 54,000 people were diagnosed with head and neck cancers in 2014, with 13,500 deaths. Historically, the death rate is high due to late-stage diagnosis and intervention.
Currently, most patients are detected through a visual exam or via their symptoms, followed by a biopsy. But by that point, two-thirds of cases have metastasized and reached Stage III or Stage IV. Surgical removal may require reconstruction of portions of the oral cavity or facial features. Therapy may be required to assist in speech and chewing. Early diagnosis of oral cancer, though, results in a cure rate of 80% to 90%.