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Clinical Genomics Announces New Publication from Flinders Medical Centre

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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.

“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.

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