Clinical Genomics Announces Publication of Additional Clinical Data for COLVERA® Recurrence monitoring Blood Test for Colorectal Cancer Patients

-- Detection of cancer-related epigenetic changes in circulating DNA was more sensitive than the current standard of care for colorectal cancer (CRC) recurrence detection --

BRIDGEWATER, N.J. — September 22, 2020 — Clinical Genomics (“CG” or the “Company”), a provider of cancer diagnostic solutions, including liquid biopsy tests for recurrence monitoring of colorectal cancer (CRC), today announced the publication of the NOVA clinical trial in the prestigious Cancer Epidemiology, Biomarkers & Prevention Journal. This U.S. population study further reinforces the performance of COLVERA®, the breakthrough blood test for the clinical presence of CRC recurrence in patients amenable to curative intent.

This peer-reviewed publication of the NOVA study was carried out in collaboration with 24 community and academic centers throughout the U.S. and included 322 patients undergoing standard of care recurrence surveillance after definitive treatment for stage II/III CRC. The findings further substantiate the importance of this blood test for post-treatment CRC patients. The data support findings observed in previous studies where COLVERA was shown to be more sensitive than CEA and identified more patients eligible to have their CRC recurrence treated with curative intent.1 

The study’s lead author, Benjamin Musher, M.D., the Barry S. Smith Endowed Professor of Gastrointestinal Malignancies at the Dan L. Duncan Comprehensive Cancer Center, Baylor College of Medicine, stated that, “COLVERA outperformed CEA in detecting recurrences of colorectal cancer after definitive therapy. COLVERA therefore represents an important advance over the current standard of care for colorectal cancer surveillance.”

When compared with standard of care radiographic imaging, sensitivity for CRC recurrence was 63% (CI 42.4-80.6) and 48% (CI 28.7-68.1) for COLVERA and CEA (≥5ng/mL), respectively, while specificity was 91.5% (CI 87.7-94.4) and 96.3% (CI 93.4- 98.1), respectively. Smoking and age were independent predictors of CEA but not COLVERA positivity. 

The primary objective of guideline-recommended surveillance after definitive treatment for CRC is early detection of recurrent disease when the disease is still amenable to potentially curative surgical resection2,3. Current blood-based detection methods, like CEA, experience limited sensitivity and can be false positive due to non-cancer conditions, such as smoking and chronic inflammatory diseases. 

Detection of cancer-related epigenetic changes in circulating DNA (hypermethylation of BCAT1 and IKZF1 genes) using a single-time point COLVERA blood test was more sensitive than the current standard of care, CEA, for CRC recurrence detection. The improved sensitivity of COLVERA was not associated with race, age, gender and smoking.

“We are pleased that the findings of this new clinical study have been published in this preeminent journal. The use of a more sensitive assay during surveillance has the potential for enhanced detection of CRC recurrence and provides an opportunity for early curative intervention, and ultimately leading to improved patient outcomes in recurrent CRC,” stated Betsy Hanna, President and CEO of Clinical Genomics. 

https://cebp.aacrjournals.org/content/early/2020/09/19/1055-9965.EPI-20-0574

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.

About COLVERA
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 United States. 

About Colorectal Cancer
Colorectal cancer is the third most commonly diagnosed cancer and the second-leading cause of cancer-related deaths in the United States, 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.
T: 212-452-2793
E: lwilson@insitecony.com

COLVERA is a registered trademark of Clinical Genomics Pathology PTY Ltd.

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1 Graeme P. Young, Susanne K. Pedersen, Scott Mansfield, David H. Murray, Rohan T. Baker, Philippa Rabbitt, Susan Byrne, Libby Bambacas, Paul Hollington & Erin L. Symonds. A cross-sectional study comparing a blood test for methylated BCAT1 and IKZF1 tumor-derived DNA with CEA for detection of recurrent colorectal cancer. Cancer Medicine 2016. doi: 10.1002/cam4.868

2 Hines RB, Jiban MJH, Choudhury K, Loerzel V, Specogna AV, Troy SP, et al.Post-treatment surveillance testing of patients with colorectal cancer and the association with survival: protocol for a retrospective cohort study of the Surveillance, Epidemiology, and End Results (SEER)-Medicare database. BMJ Open.2018;8(4):e022393.

3 Sargent D, Sobrero A, Grothey A, O'Connell MJ, Buyse M, Andre T, et al.Evidence for cure by adjuvant therapy in colon cancer: observations based on individual patient.