Clinical OMICS

JUL-AUG 2019

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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34 Clinical OMICs July/August 2019 www.clinicalomics.com Alex Philippidis Senior News Editor I f companion diagnostics (CDx) were people, they would be old enough to drink. The first CDx won FDA approval in 1998, when Dako Denmark (since acquired by Agilent Technologies) received authorization to market HercepTest. The immuno- histochemistry (IHC) assay was designed to detect human epidermal growth factor receptor 2 (HER2) protein overexpression in breast tumors of patients who may ben- efit from Herceptin (trastuzumab), a targeted therapeutic for certain types of breast cancer marketed by Genentech (now a member of the Roche Group). As of June 19, the FDA listed 38 cleared or approved CDx "devices" on its website. The CDx market is projected to more than triple from $3.153 billion in 2018 to $10.656 billion in 2025, according to Energias Market Research, which forecasts a compound annual growth rate of 19% between 2019–2025. Following are profiles of eight CDx developers to watch for their track record, including recent activity in the field. 8 Companion Diagnostic Developers Making a Mark MixAll Studio / iStock / Getty Images

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