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Innovative blood test shows early promise for effective colorectal cancer screening

BRIDGEWATER, New Jersey – Clinical Genomics presented research detailing the observed effectiveness of a next-generation, blood-based colorectal cancer screening test at the annual United European Gastroenterology Week (UEGW) meeting in Barcelona, Spain. The presentation is the first set of data to support the clinical validity of this next-generation screening innovation.

Specifically, the data demonstrate the performance of a circulating tumor DNA (ctDNA) blood test that detects three genes, BCAT1, IKZF1 & IRF4, that have been shown to be chemically modified, or hypermethylated, in colorectal cancer (CRC). An estimated one-third of adults in the United States aged 50 to 74 years have not been screened for CRC. The main goal of this research is to validate a test that is both easier to prescribe for providers and easier to comply with for all patients. Samples used in this study were acquired from Denmark, Australia, the Netherlands and Russia.

Results in this study of data from 1,621 subjects show that the performance of this next-generation blood-based screening test is comparable to currently available non-colonoscopy CRC screening tests like fecal immunochemical tests (FIT). Overall sensitivity reported for the assay for cancer (74 percent, N=184) compares to previous studies using FIT while maintaining high specificity (90 percent).

The poster abstract is available on the meeting website:

Comments by Clinical Genomics 

At the presentation, Dr Lawrence LaPointe, Clinical Genomics’ chief innovation officer commented, “These results reinforce the significant potential of blood-based testing for colorectal cancer screening. With a specificity of 90 percent, the 3-gene methylation ctDNA blood test had an overall sensitivity for CRC of 74 percent and was positive for 67 percent of early stage I and II cancers. These data support proceeding to validation of our latest innovation in true screening populations,” he concluded.

Betsy Hanna, Clinical Genomics’ chief executive officer and president said, “Clinical Genomics’ mission is to save lives and reduce healthcare costs with easy-to-use and affordable tests for the detection and monitoring of colorectal cancer. Our goal is to use our proprietary technology to enable a new and powerful option for improved testing compliance and CRC detection through a standard blood test.”

Colorectal cancer is a cancer of the colon and 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 his or her lifetime.

This disease is the second leading cause of cancer death in women and third for men. Colorectal cancer has a high 5-year recurrence rate, in which the cancer often spreads to the liver and lungs.

According to the Centers for Disease Control and Prevention, approximately 145,600 new cases of colorectal cancer are diagnosed in the US annually.

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.

The COLVERA™ blood test used in monitoring for colorectal cancer recurrence directly detects circulating tumor DNA. The company is currently clinically validating the use of this proprietary technology in a next-generation innovation, a blood test for colorectal cancer screening. The company’s portfolio also includes the FDA-cleared InSure® ONE™, an at-home collection screening tool for the detection of blood in stool. From blood tests to at-home collection tests, Clinical Genomics aims to span the spectrum of colorectal cancer diagnostics.




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