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  1. Roche’s liquid biopsy test gets US approval

Roche’s liquid biopsy test gets US approval

The US Food and Drug Administration on Wednesday approved Roche Holding AG's liquid diagnostic test to detect gene mutation associated with non-small-cell lung cancer (NSCLC), the most common type of lung cancer.

By: | Published: June 2, 2016 9:17 AM

The US Food and Drug Administration on Wednesday approved Roche Holding AG’s liquid diagnostic test to detect gene mutation associated with non-small-cell lung cancer (NSCLC), the most common type of lung cancer.

Cobas EGFR Mutation Test v2, a blood-based companion diagnostic for cancer drug Tarceva, is the first FDA-approved genetic test that can detect epidermal growth factor receptor (EGFR) gene mutations which are present in about 10-20 percent of NSCLC patients.

The FDA said the detection of the mutations aids in selecting patients who may benefit from treatment with Tarceva, manufactured by Astellas Pharma Inc and distributed by Roche’s Genentech unit.

NSCLC tumors may shed DNA into a patient’s blood, making it possible to detect specific mutations in blood samples.

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