About

Our History

​Clinical Genomics has a long and successful history in the field of colorectal cancer (CRC) screening and monitoring.

1997

Enterix begins development of the innovative InSure brush-based Fecal Immunochemical Test (FIT)

2000

InSure® introduced in the Australian market

2001

Insure® obtains US FDA 510(l) clearance

2002

Enterix works with Congress and CMS to change federal law to allow Medicare to provide coverage and pay for innovative new CRC screening tests such as InSure®.

2003

Enterix obtains a positive National Coverage Determination from CMS for the use of FIT tests for CRC screening; Quest Diagnostics selects InSure as its nationwide FIT test.

2004

Enterix obtains nationwide coverage and payment policies from private health insurance companies for the use of FIT tests for CRC screening.

2006

Clinical Genomics founded by members of the Enterix team, with ongoing support from Quest Diagnostics, after Enterix was sold to Quest Diagnostics, to develop genetic technology to detect CRC.

2010

Clinical Genomics demonstrates initial proof of concept of a blood test for CRC.

2013

Acquires Enterix from Quest Diagnostics as part of expanded collaboration with Clinical Genomics

2015

Four peer-reviewed journal articles published documenting clinical validity of COLVERA® in over 3,800 patients.

2016

Establishment of US-based molecular diagnostics pathology lab in Bridgewater, NJ

2017

Clinical Genomics launches COLVERA®, a proprietary blood test which monitors for recurrence of colorectal cancer by detecting the presence of circulating tumor DNA.

2018

Clinical Genomics appoints Betsy Hanna as CEO and establishes key commercial partnership with Quest Diagnostics for screening

2019

Completion of validation of screening program with data from over 2,000 subjects

2020

Publication of additional positive data reinforcing key benefits of COLVERA® in Cancer, the peer-reviewed journal of the American Cancer Society