Data Presented at ASCO Annual 2017 Shows Clinical Utility of Colvera™ in Assessing and Monitoring Patients Following Surgical Resection of Colorectal Cancer

BRIDGEWATER, N.J., June 09, 2017

Clinical Genomics, a private company developing innovative diagnostic tools for colorectal cancer, presented data demonstrating the utility of Colvera™, a 2-gene blood test, in measuring residual disease in patients with invasive colorectal cancer (CRC) at the American Society of Clinical Oncology 2017 Annual Meeting in Chicago, IL last week.

In this prospective correlative study, pre-and post-surgery blood samples from 93 patients with invasive colorectal cancer patients were assayed for methylation in two genes, BCAT1 and IKZF1, to demonstrate the impact of tumor resection on ctDNA levels and to identify factors associated with positive results following tumor resection.

Results showed 35 of the 47 patients (74%) who were ctDNA positive prior to surgery became negative after resection. In the 12 cases who remained positive after surgery, incomplete resection was observed in 5/12 patients. In contrast only 1/35 patients who became negative following surgery exhibited incomplete resection.

The data concluded a positive ctDNA result following resection is associated with features pointing to incomplete resection or possible residual tumor. Furthermore, residual or recurrent disease should be suspected in cases who are ctDNA positive by Colvera after surgery. Detection of methylated BCAT1 and IKZF1 in blood appears clinically useful for assessing adequacy of primary surgery and potential for recurrence.

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Colorectal Cancer
Colorectal cancer 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 developing innovative products for colorectal cancer (CRC) diagnosis. 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 colorectal cancer screening InSureĀ® 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 and recently launched Colvera™, a sensitive and specific blood-based circulating tumor DNA (ctDNA) test for colorectal cancer recurrence monitoring that detects methylated DNA from two genes, BCAT1 and 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.

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