Biomedical Laboratory Science

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Saturday, June 25, 2016

FDA Approves First Liquid Biopsy Test for Lung Cancer Patients

On June 1, the U.S. Food and Drug Administration (FDA) approved a liquid biopsy test, a companion diagnostic test called cobas EGFR Mutation Test v2. The test uses plasma samples to identify patients with metastatic non-small cell lung cancer (NSCLC) eligible for treatment with the EGFR-targeted therapeutic erlotinib (Tarceva).

The test detects specific alterations in the gene epidermal growth factor receptor (EGFR): exon 19 deletions or exon 21 (L858R) substitution mutations. These mutations are present in about 10 to 20 percent of NSCLCs, the most common type of lung cancer.

This is the first liquid biopsy test approved for use by the FDA.


Source: aacr

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