Clinical Genomics Working with Leading Cancer Center to Evaluate Colvera™ in Patients with Colorectal Cancer

New study will use Colvera to measure circulating tumor DNA (ctDNA) in rectal cancer patients

BRIDGEWATER, N.J. – October 19, 2017 – Clinical Genomics, a leading provider of cancer testing solutions, today announced the initiation of a new rectal cancer therapy monitoring study with investigators at Memorial Sloan Kettering Cancer Center (MSK). The study's goal is to evaluate the ability of Clinical Genomics' Colvera™ liquid biopsy assay to indicate the presence or absence and relative mass of a patient's tumor prior to and during chemoradiation therapy, as well as after surgery intended to remove any remaining tumor tissue. Martin R. Weiser, MD, the Stuart H.Q. Quan Chair in Colorectal Surgery at MSK, is the Principal Investigator of this clinical trial.

"We are extremely honored to have this opportunity to work with Dr. Weiser and the colorectal surgery team at MSK. Colvera is an exciting new test that detects ctDNA associated with CRC tumor tissue. While Colvera is currently being used by physicians around the country to detect minimal residual disease following surgery and to monitor for recurrent CRC, this trial is the first US-based research effort to use Colvera to monitor clinical response to therapy and to assess the efficacy of that therapy in subsequent follow up," said Lawrence LaPointe, PhD, CEO of Clinical Genomics.

"Our group is interested in understanding whether new biomarkers can inform our decision-making with respect to how we treat patients with rectal cancer," commented Dr. Weiser. "Currently, we have no reliable method to indicate whether standard neoadjuvant therapies have shrunk or eradicated a rectal cancer tumor and therefore allow us to delay or avoid invasive surgery. ctDNA assays hold the promise of providing this information, and we look forward to observing how this trial progresses."

MSK is currently enrolling patients with rectal cancer for this trial. Initial data is anticipated to be available by the middle of next year.

About Clinical Genomics

Clinical Genomics is dedicated to improving patient outcomes through earlier detection of colorectal cancer.  Clinical Genomics products span the full spectrum of colorectal cancer testing, including InSure® FIT™, a fecal immunochemical test for screening in healthy adults, to COLVERA™, a proprietary blood test identifying circulating tumor DNA in patients post-treatment for early detection of recurrence and residual disease. Clinical Genomics is committed to developing and delivering solutions that provide physicians and their patients with information to help guide earlier and better treatment decisions in cancer care management. Clinical Genomics continues to apply its proprietary innovation in molecular pathology to commercialize other diagnostic tools in other cancer types.

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