Clinical Genomics Announces the Launch of Colvera™ for Colorectal Cancer Recurrence Monitoring

Centralized CLIA-registered laboratory commences operations

BRIDGEWATER, N.J. – December 20, 2016 – Clinical Genomics, a private company developing evidence-based diagnostic tools for colorectal cancer, today announced the launch of Colvera™, a blood-based test for colorectal cancer (CRC) recurrence monitoring. Colvera is the result of a decade of research, development and clinical validation in more than 4,000 patients. Colvera will be performed in Clinical Genomics' dedicated CLIA-registered laboratory in Bridgewater, NJ.  

Quest Diagnostics, the world's leading provider of diagnostic information services, will provide specimen collection and logistics services for Colvera test orders. Terms of the agreement were not disclosed.

"Colorectal cancer outcomes improve with early detection, but many recurrence monitoring tests fail to detect disease at a point when clinical intervention has the best chance to be effective," said Lawrence LaPointe, Ph.D., President and CEO of Clinical Genomics. "Colvera is a new test that can aid in the identification of molecular changes associated with cancer development. Colvera is intended to provide physicians with actionable information that can trigger further clinical assessment, which may lead to improved outcomes."

Colvera is a qualitative test that indicates the presence or absence of two altered genes associated with CRC. Colvera measures methylation – a genetic change associated with cancer development – in circulating tumor DNA (ctDNA), the fragments of genetic material that leak from a tumor into the bloodstream. Unlike DNA mutations, which are frequent in cancer but may vary widely between patients and may undergo mutation shifts during the course of disease, methylation is a more stable feature in tumors that is readily measured. Colvera is not intended to stratify the risk of recurrence in colorectal cancer patients, but rather to identify the presence of disease at the time of testing.

In a study recently published in the peer-reviewed journal Cancer Medicine, clinical data showed that Colvera detected twice the number of recurrence cases as carcinoembryonic antigen (CEA) testing, the standard blood test used for CRC recurrence monitoring. As Colvera only requires a peripheral blood sample, the test can be administered along with other CRC surveillance tests, including CEA. Colvera does not require specialized equipment or modifications to clinical protocol.

"This is a welcome development in the field of colorectal cancer recurrence monitoring," noted Peter Mencel, M.D., a medical oncologist with Atlantic Hematology Oncology, in Manasquan, New Jersey. "Our goal is to help our patients by detecting a recurrence at the earliest possible time, when the opportunity to undertake curative surgery is greatest. I am hopeful that Colvera will provide clinicians with a new and more informative tool to guide management of our patients."

Clinical Genomics is actively pursuing several research-based collaborations with leading academic and private cancer centers to continue to expand the clinical applications of Colvera.

About Colorectal Cancer

Colorectal cancer (CRC) is one of the leading causes of cancer-related deaths worldwide, accounting for more than 600,000 deaths each year. When diagnosed early, before cancer has spread, the relative five-year survival rate for CRC is 90 percent, but only approximately four out of 10 CRC cases are detected early. Among individuals undergoing surgical treatment for CRC, recurrence occurs in 30 to 50 percent of all cases, the majority of which present in the first two to three years following initial diagnosis and treatment.

About Clinical Genomics

Clinical Genomics is a privately held biotechnology company committed to reducing the impact of colorectal cancer (CRC) through early detection of disease and clinically actionable, evidence-driven recurrence monitoring tools. With a broad intellectual property portfolio consisting of more than 20 patents, Clinical Genomics, via its wholly-owned subsidiary Enterix Inc., currently offers the user-friendly, patient-preferred CRC screening InSure® FIT™ assay, a fecal immunochemical test that detects blood in the stool. InSure is also marketed as a lab-based test in Australia and other countries (ColoVantage Home). Building on an established history in the field of CRC screening and diagnosis, Clinical Genomics developed Colvera, a blood-based circulating tumor DNA (ctDNA) test for colorectal cancer based on methylated DNA from two genes, BCAT1 and/or IKZF1.

Clinical Genomics has offices and laboratories in Bridgewater and Edison, New Jersey and Sydney, Australia, and operates as an FDA-registered and TGA-licensed manufacturer and a NATA-accredited laboratory.

For more information, please visit www.colveratest.com and www.clinicalgenomics.com.

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