Clinical Genomics Announces Poster Presentation At the 2019 ASCO Annual Meeting

COLVERA™ Blood Test Provides Improved Effectiveness

Detecting Recurrence of Colorectal Cancer

Bridgewater, NJ – Monday, June 3, 2019 – Clinical Genomics today 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.

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.

The poster is available on the Clinical Genomics website at:  https://www.clinicalgenomics.com/abstracts–posters.html.

Dr. Lawrence LaPointe, Chief Innovation Officer at Clinical Genomics, commented, “These results reinforce the effectiveness of COLVERA. This study demonstrated COLVERA detects two methylated genes specific to colorectal cancer in circulating tumor DNA (ctDNA), a technology with greater sensitivity for colorectal cancer recurrence than measuring for CEA. We also see there are advantages of COLVERA compared to next generation sequencing 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.”

Betsy Hanna, President and Chief Executive officer of Clinical Genomics, said, “COLVERA is a commercially available ctDNA CRC recurrence monitoring test in the US. This test is more sensitive and cost-effective than the current standard of care. Since its launch in 2017, we see colorectal surgeons and oncologists increasingly adopting COLVERA as their blood test of choice for recurrence monitoring.”

“Today’s encouraging findings will likely accelerate growth ─ and patients will benefit.  We remain focused on advanced research efforts and published clinical trials. Our NOVA clinical trial, focused on clinical utility of COLVERA, has more than 25 physicians enrolled at over 40 clinical sites, and we have several independent studies underway,” Hanna continued.

This study is a follow on 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

About Colorectal Cancer

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 spread is most likely to the liver and lungs.

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 a blood test for detecting colorectal cancer recurrence. The test has demonstrated through studies to have twice the sensitivity compared to the standard of care blood test for CEA.

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.

About: Clinical Genomics

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.

Our blood test used in the monitoring of colorectal cancer, COLVERA™, directly detects circulating tumor DNA. The company is currently clinically validating the use of our proprietary technology in 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.

The company is headquartered in Bridgewater, New Jersey, with laboratories and manufacturing facilities in North America and Australia.

For more information, please visit https://www.clinicalgenomics.com/