HISTORY

Clinical Genomics has a long and successful history in the field of colorectal cancer (CRC) screening and diagnosis:

 

2017
Clinical Genomics launches COLVERA®, a proprietary blood test identifying methylated circulating tumor DNA in colorectal cancer patients post-surgery for the detection of residual disease and post-treatment for surveillance of colorectal cancer recurrence.

2016
Establishment of US-based molecular diagnostic pathology lab in Bridgewater, NJ

2015
Four peer-reviewed journal articles published documenting clinical validity of Colvera in over 3,800 patients

2013
Acquires Enterix from Quest Diagnostics as part of expanded collaboration with Clinical Genomics

2010
Clinical Genomics demonstrates initial proof of concept of a blood test for CRC

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

2004
Enterix obtains nationwide coverage and payment policies from private health insurance companies for the use of FIT tests for CRC screening

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

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

2001
InSure obtains US FDA 510(k) approval

2000
InSure introduced in the Australian market

1997
Enterix begins development of the innovative InSure brush-based Fecal Immunochemical Test (FIT)

 

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