FDA approves Roche’s cobas EGFR blood test as a companion diagnostic for AZ’s Iressa

The FDA's OK follows companion diagnostic approvals in NSCLC for tyrosine kinase inhibitors Tarceva and Tagrisso. (Roche)

The FDA granted a new indication to Roche’s cobas EGFR Mutation Test v2, clearing its use as a noninvasive companion diagnostic for AstraZeneca’s Iressa (gefitinib) in first-line non-small cell lung cancer.

The approval follows green lights for use with NSCLC tyrosine kinase inhibitor (TKI) therapies Tarceva (erlotinib), by Roche’s Genentech, as well as AZ’s Tagrisso (osimertinib). For Iressa, the cobas EGFR test was cleared for use with either tumor tissue samples or through liquid plasma biopsy, the only FDA-approved companion diagnostic for NSCLC cleared for this use.

In addition, the test can provide results in less than one day from sample preparation to report, said Uwe Oberlaender, head of Roche Molecular Diagnostics.


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Performed on the cobas 4800 System, the polymerase chain reaction-based test screens for 42 mutations of the EGFR gene in exons 18-21, including L858R, exon 19 deletions and T790M mutations, Roche said, to identify patients most likely to respond to TKI therapies.

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Roche’s 2016 Tarceva approval marked the first FDA nod for a liquid biopsy test for clinical decision-making. At the time, EGFR testing via invasive biopsies were only performed in about 25% of patients, the company said. If the mutations are not found in the blood, a tumor biopsy would still be performed, but a positive result would allow patients to avoid the procedure.

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