About

Why Clinical Genomics

Advanced Tests Made Possible by Our Proprietary Technology

Our blood test for colorectal cancer, COLVERA®, monitors for recurrence of colorectal cancer through the detection of circulating tumor DNA (ctDNA). We are also clinically validating our breakthrough technology to offer what we see will be the first widely adopted blood test for colorectal cancer screening. These advances will continue to build on our established screening offering, which includes InSure® ONE™, a user-friendly, in-home collection test for blood in stool that has been proven to encourage more people to be screened.*

*A randomized trial of the impact of new fecal hemoglobin test technologies on population participation in screening for colorectal cancer. Cole et al. Journal of Medical Screening 2003

Our Technology

Our innovative technology has been proven to be accurate, affordable and easy-to-use.

COLVERA®

COLVERA is a 2-gene ctDNA blood test for Colorectal Cancer (CRC) recurrence monitoring, offering 68% sensitivity and 93% specificity (Ref:COLVERA makes use of a sensitive PCR-based method (amplification of tiny amounts of DNA) to detect two genes (BCAT1/ IKZF1) methylated (or silenced) in colorectal cancer.)

COLVERA does not depend on the presence of specific gene mutations and has been shown to detect twice the number of cancers as the current standard of care (Ref: Symonds et al, Cancer, 2020)

COLVERA identifies the presence of ctDNA, the gating determinant for recurrence diagnosis and delivers superior health economics.

Detect recurrence when case amenable to curative intent (4)

  •  80% of recurrences occur within 2 years of primary treatment (4)
  •  Detects > 2x the cancers as the current standard of care (5)

COLVERA For Minimal Residual Disease

In addition to detecting recurrences, physicians may choose to use COLVERA® to evaluate residual disease in patients who have had their cancer surgically removed.  A recently published study concluded “ The presence of ctDNA in blood is stage-related and

show rapid reversion to negative following surgical resection. Monitoring methylated BCAT1 and IKZF1 levels could therefore inform adequacy of surgical resection.” (4)

COLVERA is a Laboratory Developed Test supplied by Clinical Genomics Pathology Inc. a CLIA Certified, CAP-accredited laboratory in Bridgewater, NJ, USA. 

 4. Erin Symonds “Circulating Tumour DNA for monitoring colorectal cancer—a prospective cohort study to assess relationship to tissue methylation, cancer characteristics, and surgical resection.” Clinical Epigenetics 2018  

InSure® ONE™

InSure® ONE™ is a fecal immunochemical test (FIT). It is a highly accurate test for detecting blood in stool, which may be an indication of lower gastrointestinal bleeding associated with disorders such as diverticulitis, ulcerative colitis, polyps, colorectal cancer or large adenomas that bleed.

Screening

Clinical Genomics has an advanced program to bring an advanced and cost-effective screening blood test to market. This program has already generated data in more than 2,000 subjects.

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Our Leadership

The leadership team at Clinical Genomics embodies our mission of improving affordability, usability and accuracy of our detection products. Every member of our leadership team provides unique skills and insights to lead the company in decades to come.

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