1997
Enterix begins development of the innovative InSure brush-based Fecal Immunochemical Test (FIT)
Enterix begins development of the innovative InSure brush-based Fecal Immunochemical Test (FIT)
InSure® introduced in the Australian market
Insure® obtains US FDA 510(l) clearance
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®.
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 obtains nationwide coverage and payment policies from private health insurance companies for the use of FIT tests for CRC screening.
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.
Clinical Genomics demonstrates initial proof of concept of a blood test for CRC.
Acquires Enterix from Quest Diagnostics as part of expanded collaboration with Clinical Genomics
Four peer-reviewed journal articles published documenting clinical validity of COLVERA® in over 3,800 patients.
Clinical Genomics launches COLVERA®, a proprietary blood test which monitors for recurrence of colorectal cancer by detecting the presence of circulating tumor DNA.
Clinical Genomics appoints Betsy Hanna as CEO and establishes key commercial partnership with Quest Diagnostics for screening
Completion of validation of screening program with data from over 2,000 subjects
Publication of additional positive data reinforcing key benefits of COLVERA® in Cancer, the peer-reviewed journal of the American Cancer Society