MedicalResearch.com Interview with:
Lawrence LaPointe, Ph.D.
Chief Innovation Officer
Bridgewater, New Jersey
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Colorectal cancer is a cancer of the colon and the rectum. The American Cancer Society estimates that about 1 in 21 men and 1 in 23 women in the United States will develop colorectal cancer during their lifetime.
This disease is the second leading cause of cancer death in women, and the third for men. Colorectal cancer has a high 5-year recurrence rate and most likely is spread to the liver and lungs.
Clinical Genomics has two decades of experience striving to save lives and reduce costs by developing easy-to-use tests for the detection of colorectal cancer. With breakthrough diagnostic tools, the company aims to offer affordable and accurate tests, supporting physicians and patients with potential life-saving knowledge about colorectal cancer.
On June 3, 2019, Clinical Genomics presented research detailing breakthrough methods of colorectal cancer recurrence monitoring at the American Society of Clinical Oncology (ASCO) annual meeting in the McCormick Place Convention Center, Chicago.
MedicalResearch.com: MedicalResearch.com: What are the main findings?
Response: The presentation outlined a research study comparing the effectiveness of COLVERA™, an innovative genomic test, with the standard of care blood-based test for detection of carcinoembryonic antigen (CEA), for monitoring colorectal cancer (CRC) recurrence.
The findings indicated that COLVERA was more sensitive for detecting recurrent colorectal cancer and could detect relapse up to several months earlier than the CEA test. Importantly, COLVERA detected recurrent cancer in 60% of cases amenable to surgery with curative intent versus 20% for CEA. These data showed COLVERA to have a positive predictive value of 94%, meaning if the COLVERA result was positive, the physician should consider a high chance of cancer recurrence and to monitor the patient accordingly.
MedicalResearch.com: What should readers take away from your report?
Response: These results reinforce the effectiveness of COLVERA. This study demonstrated COLVERA detects two methylated genes, BCAT & IKZF1, specific to colorectal cancer in circulating tumor DNA (ctDNA), a technology with greater sensitivity for colorectal cancer recurrence than measuring for CEA. A good example of increased sensitivity is the case, in the study, where COLVERA was positive up to 11 months before confirmation of recurrence while no CEA test was positive more than six months before recurrence confirmation.
We also see there are advantages of COLVERA compared to next generation sequencing (NGS) ctDNA tests for CRC recurrence. Unlike NGS liquid biopsy tests, COLVERA does not require knowledge of the primary tumor mutational status and is a much lower cost qPCR test.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: We are currently working towards completing the COLVERA North American Validation Trial (NOVA) this year. NOVA specifically aims to develop clinical utility evidence for COLVERA by comparing it to paired carcinoembryonic antigen (CEA) testing in subjects who have undergone treatment for CRC and are in remission. The trial currently includes about 600 patients across roughly 40 different academic groups including the Baylor College of Medicine, the University Hospitals Cleveland Medical Center, Cedars-Sinai, Indiana University, and Penn Medicine Princeton Health.
In addition to NOVA, there are several other studies in progress to help gain full reimbursement for COLVERA and of course to look at COLVERA benefits longitudinally. Data from these studies will be shared publicly this year and next.
MedicalResearch.com: Is there anything else you would like to add?
Response: Adoption by surgeons and oncologists for post-surgery residual disease detection and recurrence monitoring has been accelerating. COLVERA has been designed for routine surveillance following curative therapy for colorectal cancer with the aim to improve the chance of long-term survival by early detection of operable metastatic disease.
Any disclosures? The poster that was presented at the ASCO annual meeting is available on the Clinical Genomics website at: https://www.clinicalgenomics.com/abstracts–posters.html
This study is a follow up to a previous cross‐sectional study comparing a blood test for methylated BCAT1 and IKZF1 tumor‐derived DNA with CEA for detection of recurrent colorectal cancer published in October 2016. The abstract to the original study is available at: https://onlinelibrary.wiley.com/doi/full/10.1002/cam4.868
Citation: ASCO 2019 abstract
DOI: 10.1200/JCO.2019.37.15_suppl.3589 Journal of Clinical Oncology 37, no. 15_suppl (May 20 2019) 3589-3589.
Published online May 26, 2019.
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