24 April 2018 - - Pleasanton, Califormia-based diagnostic products developer Roche Molecular Diagnostics (RMD), a member company of Basel, Switzerland-based biotech company Roche (SIX: RO, ROG; OTCQX: RHHBY) has received approval from the US Food and Drug Administration of its premarket approval supplement for the cobas EGFR Mutation Test v2, the company said.
The new indication allows the test to be used as a companion diagnostic test with AstraZeneca's Tagrisso (osimertinib) for first line treatment of patients diagnosed with metastatic NSCLC whose tumours have epidermal growth factor receptor exon 19 deletions or exon 21 L858R mutations.
A companion diagnostic test is a medical device which provides information that is essential for the safe and effective use of a corresponding therapeutic product.
The test is also a companion diagnostic test with Tarceva (erlotinib) for NSCLC patients who test positive for the EGFR exon 19 deletion or L858R sensitizing mutations.
Approvals thus far are for both tissue and liquid (patient blood plasma) biopsy. EGFR testing in plasma offers a non-invasive option for patients using a simple blood draw for those who are not eligible for a tissue biopsy. In addition, the workflow for cobas EGFR Mutation Test v2 enables patients and clinicians to obtain results in as little as one day.
The cobas EGFR Mutation Test v2 is a real-time PCR test for the qualitative detection of 42 defined mutations of the EGFR gene in exons 18-21, including L858R, exon 19 deletions, and T790M mutations.
RMD develops and manufactures a wide array of medical diagnostic products for researchers, physicians, hospitals, laboratories, and blood banks worldwide.
Roche combines pharmaceuticals and diagnostics to provide a personalised healthcare strategy that fits the right treatment to each patient in the best way possible.
The company continues to search for better ways to prevent, diagnose, and treat disease, to make a sustainable contribution to society, and to improve patient access to medical innovations by working with all relevant stakeholders. The Roche Group is active in over 100 countries and in 2016 employed more than 94,000 people.