Clinical Genomics has a long and successful history in the field of colorectal cancer (CRC) screening and diagnosis:
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.
Establishment of US-based molecular diagnostic pathology lab in Bridgewater, NJ
Four peer-reviewed journal articles published documenting clinical validity of Colvera in over 3,800 patients
Acquires Enterix from Quest Diagnostics as part of expanded collaboration with Clinical Genomics
Clinical Genomics demonstrates initial proof of concept of a blood test for CRC
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
Enterix obtains nationwide coverage and payment policies from private health insurance companies for the use of FIT tests for CRC screening
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
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
InSure obtains US FDA 510(k) approval
InSure introduced in the Australian market
Enterix begins development of the innovative InSure brush-based Fecal Immunochemical Test (FIT)
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