Clinical Genomics Announces New Publication from Flinders Medical Centre, Highlighting the Use of COLVERA® as a Quantitative ctDNA Biomarker for Response to Colorectal Cancer Therapy

— Article outlines advantages and provides further data to support the use of COLVERA for assessing response to treatment and risk of disease progression –

— Study finds that a COLVERA positive ctDNA result after completion of treatment is associated with a higher risk of disease progression —

BRIDGEWATER, N.J., Feb. 18, 2022 (GLOBE NEWSWIRE) — Clinical Genomics, a provider of cancer diagnostic solutions, including liquid biopsy tests for molecular residual disease (“MRD”) and recurrence monitoring of colorectal cancer (“CRC”), today announced a new publication from researchers at the prestigious Flinders Centre for Innovation in Cancer, Flinders Medical Center in Adelaide, S. Australia on COLVERA^®. COLVERA, a circulating tumor DNA (“ctDNA”) test that looks for methylation in two genes (BCAT1 and IKZF1), showed that ctDNA is an effective biomarker for risk assessment for residual CRC post-treatment.

The article, published online on January 9, 2022, in Molecular Oncology highlights the advantages of using COLVERA for assessing response to treatment and risk of disease progression. This observational study provides further data to support the use of COLVERA to monitor patients throughout their CRC journey. This study looked at quantification of methylated BCAT1 and IKZF1 to correlate the amount of ctDNA with tumor burden at diagnosis and then again after completing treatment. A positive COLVERA result after treatment completion was associated with a higher risk for disease progression. COLVERA methylation Biomarkers detect presence of disease in CRC patients regardless of their tumor stage, heterogeneity, or individual mutational profiles. In addition, the Colvera assay is non invasive and does not require surgical tissue or biopsies.

Key conclusions of the study include:

• Quantification of methylation levels of COLVERA correlates to tumor burden at diagnosis;
• Complete treatment resulted in a decrease in ctDNA levels in 97.9% (47/48) of individuals relative to the pre-treatment level; and
• Levels of methylated BCAT1/IKZF1 DNA at the time of diagnosis could serve as a baseline, providing context to changes in repeated testing as treatment is planned, adjusted and monitored.

“This simple ctDNA test, which does not require configuration based on genomic testing of a patient’s cancer, is dynamically responsive to therapeutic intervention for both colonic and rectal cancer. This demonstrates the capacity of this test to assess tumor burden and opens up possibilities for further personalization of therapeutic strategies following completion of initial therapy,” stated Senior Author Graeme Young, MD, Professor of Gastroenterology at Flinders University.

https://febs.onlinelibrary.wiley.com/doi/10.1002/1878-0261.13178

“The timely detection of residual disease and effective assessment of response to treatment are crucial in guiding appropriate interventions that will improve outcomes for patients with CRC. We are highly encouraged that the findings support the use of COLVERA as a quantitive ctDNA biomarker for response to CRC therapy. COLVERA is a highly sensitive test that overcomes some of the limitations of existing protocols for assessing residual disease. We remain dedicated to ensuring that healthcare providers have access to this game changing diagnostic,” stated Betsy Hanna, President and 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.

About COLVERA
COLVERA is a Laboratory Developed Test supplied by Clinical Genomics Pathology Inc., a CLIA Certified, CAP accredited laboratory in Bridgewater, NJ, USA. COLVERA is the first of its kind blood test to detect circulating tumor DNA for molecular 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. Introduced in 2017, COLVERA is the first liquid biopsy assay for CRC monitoring and 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, 20-30% will experience a recurrence, most within the first two years following 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.

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 Pty Ltd.