FDA Approves First Liquid Biopsy Test for Lung Cancer


Roche’s Liquid Biopsy test, Cobas® EGFR Mutation Test v2 became the first U.S. FDA approved liquid diagnostic test.

Roche pharma switzerlandIt will serve as a companion diagnostic tool to detect gene mutations associated with one of the most common type of lung cancer, non-small cell lung cancer (NSCLC).

Cobas® EGFR Mutation Test v2 will accompany the epidermal growth factor receptor (EGFR)-targeted therapy Tarceva® (erlotinib) in the diagnosis of EGFR gene mutations in DNA derived from plasma or tumor tissue. Tarceva is the first-line treatment given to NSCLC patients. It is developed and marketed by Astellas Pharma US in collaboration with Genentech in US, Chugai in Japan and Roche in rest of the world.

NSCLC accounts for approximately 85% to 90% of all lung cancers. Among them, 10% to 20% of NSCLC patients carry EGFR gene mutation who can be subjected to Tarceva treatment.

EGFR mutation in lung cancer

Figure 1. Major differences between NSCLC cells expressing wild-type and mutant EGFR.

 According to the reports, 25% of NSCLC patients do not undergo EGFR genetic testing.

pie chart lung cancer

Figure 2. Pie chart showing incidences of non-small cell lung cancers. 

cobas egfr mutation kit roche

Cobas EGFR Mutation Test v2 is an improved version of Cobas EGFR Mutation Test which is available worldwide. Technically, it is a real-time PCR test for the qualitative detection of defined mutations of the EGFR gene in DNA derived from formalin-fixed paraffin-embedded tumor tissue (FFPET) from NSCLC patients.

It can identify 42 EGFR mutations in exons 18-21, including L858R, exon 19 deletions, and T790M.

Erlotinib is a first generation reversible EGFR tyrosine Kinase Inhibitors (TKIs) approved for the treatment of NSCLC patients with EGFR gene mutation. The trend of molecular characterization of tumors is increasing to provide the most suitable therapy for the patients. The companion diagnostics improve the benefits of EGFR targeted therapy provided to the patient.

Liquid Biopsy test has become one of the hottest topics of research and development, it has been acknowledged as one of the ’10 breakthrough Technologies of 2015’ by MIT Technology Review. It can help nip cancer growth in the bud by detecting it even before the development of symptoms. Last month, San Diego based Biocept Inc. collaborated with a biopharmaceutical company to develop targeted liquid biopsy tests for multiple types of tumor and molecular targets.

Dr. Benjamin Levy, MD, Director of Thoracic Medical Oncology, Mount Sinai Health Systems and Hospital said, The advent of liquid diagnostic platforms in non-small cell lung cancer is truly a game changer in the diagnostic workup of advanced stage patients. The ability to both isolate and genetically interrogate tumor DNA from a simple, minimally invasive test that can subsequently inform treatment decisions is a win for both physician and patient“.

Invasive targeted therapies can be too harsh for the patients with poor health; sometimes obtaining sufficient amount of tumor tissue for molecular testing can be difficult. The Cobas EGFR Mutation Test v2 can fill the potholes of molecular testing as it needs plasma samples for the genetic test and it can open more options for the clinicians to improve patient’s health.

Featured image credit: Human lung with visible bronchi and trachea © animaxx3d (Stock Photo ID: 80723054)

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