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News From the Food and Drug Administration
July 19, 2016

Liquid Biopsy Receives Approval

JAMA. 2016;316(3):260. doi:10.1001/jama.2016.8833

The first blood-based genetic test—known as a liquid biopsy—that detects epidermal growth factor receptor (EGFR) gene mutations in non–small cell lung cancers has received FDA approval. The cobas EGFR Mutation Test v2 is a companion diagnostic for the cancer drug erlotinib.

Non–small cell lung cancers sometimes shed tumor DNA into the blood, making it possible to detect specific mutations in blood samples. The newly approved test detects the exon 19 deletion or exon 21 (L858R) substitution mutations in the EGFR gene that are linked with erlotinib-sensitive non–small cell lung cancer (http://1.usa.gov/1Uvkn3N). It can be used with tumor tissue as well as blood samples.