MDxHealth, QUT Partner to Develop Oral Cancer Liquid Biopsy Assay

June 19, 2017
MDxHealth, QUT Partner to Develop Oral Cancer Liquid Biopsy Assay
MDxHealth and QUT bluebox say their planned liquid biopsy epigenetic assay will evaluate abnormal DNA methylation changes, with patients Patients contributing saliva via a non-invasive swab during routine medical or dental exams. [istock/lovleah]

MDxHealth and QUT bluebox, the commercialization arm of the Queensland University of Technology (QUT), said today they will partner to develop a liquid biopsy epigenetic assay designed for early detection of oral cancer.

The value of the collaboration was not disclosed.

The test will evaluate abnormal DNA methylation changes, an indication that a patient may have a higher risk of developing cancer. Patients will contribute saliva via a non-invasive swab during routine medical or dental exams, with samples to be sent to a lab or tested on site to determine if a patient requires clinical follow-up.

“Our test is expected to facilitate much earlier detection of oral cancer and potentially precancerous lesions by a variety of specialties including general practitioners, oncologists and dentists,” said Associate Prof. Chamindie Punyadeera, Ph.D., of QUT’s School of Biomedical Sciences and Institute of Health and Biomedical Innovation (IHBI), lead investigator for the assay development effort and creator of the test.

MDxHealth has agreed to collaborate with QUT to evaluate and develop the test, with MDxHealth holding the first option to license commercial diagnostics rights, the partners said. Proceeds will be used to support MDxHealth’s R&D pipeline for diagnostics in urologic cancers, as well as to support further research and translational activities at QUT and IHBI. 

The oral cancer exam would broaden MDxHealth’s menu of cancer tests, which are based on its MSP (Methylation-Specific-PCR) platform, a proprietary DNA-based technology that functions on standard commercial PCR equipment. According to the company, MSP is sensitive enough to detect one cancer cell among 10,000 healthy cells.

MDxHealth markets ConfirmMDx and SelectMDx, both designed to test for prostate cancer. The company has licensed its epigenetic technologies for two other marketed tests, Cologuard® for colon cancer, sold by Exact Sciences; and PredictMDx® for Glioblastoma, sold by Laboratory Corporation of America (LabCorp). MDxHealth’s development pipeline includes AssureMDx, designed to rule-out bladder cancer in patients diagnosed with hematuria.

Headquartered in Herstal, Belgium, MDxHealth operates a 13,444-square-foot molecular lab at its U.S. headquarters in Irvine, CA. The lab is College of American Pathologists (CAP)-accredited and Clinical Laboratory Improvement Amendments of 1988 (CLIA) and ISO 9001:2008 certified.

The company also carries out its NXTGNT (Epi)genomics research joint-venture with Ghent University in Ghent, Belgium.