27 May 2020
Larger Study Reaffirms COLVERA Outperforms Standard of Care
BRIDGEWATER, N.J. —May 27, 2020 — Clinical Genomics (“CG” or the “Company”), a provider of cancer diagnostic solutions, including liquid biopsy tests, today announced that the results of a 144-patient study measuring the effectiveness of its COLVERA circulating tumor DNA (“ctDNA”) blood test for recurrence monitoring of colorectal cancer (“CRC”) were published online in Cancer, the peer-reviewed journal of the American Cancer Society.
The article, entitled “Circulating Epigenetic Biomarkers for Detection of Recurrent Colorectal Cancer,” describes results of the study demonstrating again that COLVERA has higher sensitivity for recurrent cancer over the current standard of care, carcinoembryonic antigen (“CEA”)(1), in a larger study population. In this study, the sensitivity of COLVERA was twice the sensitivity for CEA. The current study included 47 cases of recurrence with paired sample blood test results for COLVERA and CEA, matched with radiological results, an increase over the number of recurrence cases (28) included in the 2016 data set and represents the largest set of recurrence cases reported in a CRC ctDNA study to date.
In this larger patient pool, the study showed that the sensitivity of COLVERA for recurrence, as determined by concurrent radiology findings, was 66.0% based on a single testing time point compared to 31.9% for CEA, (P<.001). The specificity values for the tests were not statistically different: ctDNA COLVERA was 90.4%, and CEA was 96.4%. Additionally, the authors conducted an assessment of the data using a quantitative cutoff for COLVERA (12.8 pg/mL) that showed no change in sensitivity while increasing specificity to 97.9%.
“This new study is an important step in showing the ability of the COLVERA ctDNA blood test to detect colorectal cancer recurrence earlier for our patients. With the increased sample size, it further demonstrates a consistently higher sensitivity of the COLVERA ctDNA blood test over the current standard of care,” said Dr. J. Ryan Williams, M.D. FACS. “I think there is much promise in the use of this blood test for our patients, and am excited to see how future research may be used to guide our use in the care of our colorectal cancer patients.”
“We are very encouraged by the positive benefits of COLVERA for CRC patients and believe it provides a more effective tool for clinicians as they care for their patients. The results of this study in Cancer demonstrate the ability of the COLVERA blood test to more accurately detect CRC recurrence in, what we believe to be, the largest data set of its kind. COLVERA’s greater sensitivity compared to the standard of care has the potential to save patients’ lives,” stated Betsy Hanna, CEO of Clinical Genomics.
About Clinical Genomics
Clinical Genomics is dedicated to improving patient outcomes through early detection of colorectal cancer. Clinical Genomics’ products span the full spectrum of colorectal cancer testing from screening to post-treatment monitoring. 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.
COLVERA is the first of its kind blood test to detect circulating tumor DNA for minimal residual disease (“MRD”) assessment and recurrence monitoring in patients previously diagnosed with colorectal cancer. COLVERA targets aberrant methylation of two genes (BCAT1 and IKZF1) and is mutation agnostic. COLVERA does not require any form of tissue biopsy prior to use. Introduced in 2017, COLVERA has been ordered by hundreds of colorectal surgeons and medical oncologists across the U.S.
About Colorectal Cancer
Colorectal cancer is the third most commonly diagnosed cancer and the second leading cause of cancer-related deaths in the U.S., with more than 140,000 people per year expected to be diagnosed with CRC and over 50,000 succumbing to the disease annually. For patients who survive, 30%-50% will experience a recurrence, most within the first two to three years of primary treatment. On average, the lifetime risk of developing colorectal cancer is about one in 23 for men and women combined, however, this varies widely according to individual risk factors.
Future Matters and Forward Looking Statements
Certain statements in this press release constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements that address expectations or projections about the future, including statements about product development, market position, expected expenditures and financial results, are forward-looking statements. Some of the forward-looking statements may be identified by words like “expects,” “anticipates,” “plans,” “intends,” “projects,” “indicates,” and similar expressions. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. These statements are not guarantees of future performance and involve a number of risks, uncertainties and assumptions. Accordingly, the Company’s actual results or performance may differ significantly, positively or negatively, from forward-looking statements made herein. Unanticipated events and circumstances are likely to occur. Factors that might cause such differences include, but are not limited to, anticipated funding proving to be unavailable; intense competition in the market resulting in lower than anticipated revenues or higher than anticipated costs; and general economic conditions, such as the rate of employment, inflation, interest rates and the condition of the capital markets. This list of factors is not exclusive. The Company undertakes no obligation to update any forward-looking statements.
Investor Relations for Clinical Genomics
Lisa M. Wilson, In-Site Communications, Inc.
Posted in — Media Release