Clinical Genomics Technologies

About

Clinical Genomics develops and commercializes colorectal cancer diagnostics, including Colvera, a two-gene (BCAT1/IKZF1) methylated DNA liquid‑biopsy for recurrence monitoring, and InSure FIT fecal tests offered via CLIA/CAP labs.

Mission

Clinical Genomics commercializes Colvera™, a liquid‑biopsy blood test that detects circulating tumor DNA to identify residual disease and recurrence in colorectal cancer (CRC) patients. The company also offers InSure® FIT and the FDA‑cleared InSure® ONE™ in collaboration with Quest Diagnostics. Colvera was developed with CSIRO and Flinders University and is offered as a CLIA‑developed lab service from Clinical Genomics’ CAP‑accredited Bridgewater, NJ laboratory, licensed to provide testing in 48 US states. Clinical Genomics says Colvera can detect more than twice as many recurrent cancers as carcinoembryonic antigen (CEA) and may enable earlier detection of recurrence. Proceeds from the recent financing will be used to commercialize Colvera for earlier detection of recurrent CRC and to advance its use for CRC screening. The company intends to combine profits from InSure ONE with the new capital to build on its position in the estimated $1 billion CRC monitoring market and the $10 billion blood‑based CRC screening market. Financially, Clinical Genomics completed a $26 million financing and had raised $48 million over the prior two years. Clinical Genomics is a developer of colorectal cancer diagnostics focused on a specific blood test based on methylated DNA from two genes, BCAT1 and IKZF1. The company plans to offer this 2-gene test for post-surgical recurrence monitoring in the U.S. beginning later in 2016 and will use recent financing to advance its commercialization. Clinical Genomics also markets the patient-preferred InSure® FIT™ fecal immunochemical test via its wholly-owned subsidiary Enterix Inc.; InSure is sold in Australia and other countries as ColoVantage Home. The company holds a broad intellectual property portfolio with more than 20 issued and pending patents related to its assays. Clinical Genomics has offices and laboratories in Bridgewater and Edison, New Jersey, and Sydney, Australia, and operates as an FDA-registered and TGA-licensed manufacturer with a NATA-accredited laboratory. The company is led by President and CEO Dr. Lawrence LaPointe.

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