FDA approves Roche diagnostic test for gene mutation in lung cancer

May 15, 2013 | By Márcio Barra

Roche, the Swiss cancer drug giant, won the FDA’s Office of In Vitro Diagnostics and Radiological Health approval to sell a companion gene mutation test, that can predict how patients will respond to Tarceva (Erlotinib hydrochloride), a popular treatment for non-small lung cancer.

The diagnostic test, called the Cobas EGFR Mutation Test, detects epidermal growth factor receptor (EGFR) gene mutations, and it’s the first of its kind approved by the FDA.  The Cobas EGFR Mutation Test identifies exon 19 deletions or exon 21 substitution mutations in the EGFR gene in a patient DNA.

Terceva, the companion drug for Roche’s newly approved diagnostic test