Quest Diagnostics to Develop Blood-Based Colon Cancer Test Based On Clinical Genomics’ Gene Markers

Clinical Genomics, an Australian life sciences company, has announced today that Quest Diagnostics, the world’s leading diagnostic testing company, has exercised a commercial option under a longstanding strategic-alliance agreement to use Clinical Genomics’ gene-based biomarkers to develop a new generation of laboratory developed tests to help aid colon cancer detection in the United States.

The agreement assumes any new test will meet any required clinical, regulatory and technical validations. The biomarkers are two genes (BCAT1 and IKZF1) determined by Clinical Genomics to be associated with colorectal cancer and detectable through blood testing.

Quest Diagnostics plans to explore incorporating the markers into future generations of its ColoVantage® laboratory-developed test, assuming validation of improved performance. ColoVantage is a convenient blood test, based on the gene biomarker Septin9 that aids in the detection of colorectal cancer in patients non-adherent to current testing approaches. The company’s Nichols Institute developed and validated ColoVantage for testing orders from physicians in the United States. Additional terms were not disclosed.

“ColoVantage is the putative leading blood-based colorectal cancer detection method, and continues to generate strong interest from physicians and patients in the United States," said Jay G. Wohlgemuth, senior vice president, science and innovation, Quest Diagnostics. "Additional enhancements will only reinforce the clinical value of this significant medical advance for colon cancer.”

The research1 on which the Clinical Genomics’ markers are based is the result of over five years of scientific collaboration between Clinical Genomics, CSIRO and the Flinders Centre for Innovation in Cancer at Flinders University in Australia.

Dr. Lawrence LaPointe, the Chief Executive Officer of Clinical Genomics, said Quest Diagnostics’ commercialization decision underscores the potential of the company’s biomarkers for clinically valid testing.

“When caught early, colon cancer is highly treatable. Yet, colon cancer is a major cause of cancer death globally, largely because many patients cannot or will not be tested by colonoscopy, fecal occult blood testing and other guideline-recommended procedures, Quest Diagnostics has a record of leadership in colon cancer test innovation. Quest’s research and development expertise and national scale position it well to maximize the clinical potential of our gene markers as a testing service to aid colon cancer detection in the United States,” said Dr LaPointe.

Service to be developed for the United States market.