The clinical study will assess the performance of OralAdvance compared to the gold standard biopsy and histology for its ability to differentiate between visually suspicious oral lesions with cancer or pre-cancer and visually suspicious benign oral lesions.
OralAdvance is a new quantitative cytology test based on analysis of oral brush specimens. The test provides an objective measure of gross DNA abnormality to determine the pre-malignant or malignant nature of a lesion. OralAdvance offers a new and useful option to assess suspicious lesions when a biopsy is not warranted or possible, the company said.
Bojana Turic, president and CEO of Perceptronix, said: Unlike many other types of cancer, the incidence and mortality rates of oral cancer have not shown significant improvement over the past 30 years. By the time most oral cancers are diagnosed, they are already symptomatic late-stage disease. At Perceptronix we are dedicated to changing this paradigm towards early detection for better patient outcomes.