FDA Approval of First Liquid Biopsy Companion Diagnostic Furthers Rise of Non-Invasive Testing

The rise of liquid biopsies predicted by G2 Intelligence’s Diagnostic Testing & Emerging Technologies (DTET) is being borne out by a recent U.S. Food and Drug Administration (FDA) approval. The FDA and Roche both recently announced the FDA approval of the cobas® EGFR Mutation Test v2 “for use with plasma samples, as a companion diagnostic for the non-small cell lung cancer (NSCLC) therapy, Tarceva®.” The FDA noted this is “the first FDA-approved, bloodbased genetic test” to detect that mutation in such patients.

Lung cancer is the leading cause of cancer-related death for men and the rate of women with lung cancer is rising, said the FDA. NSCLC in particular is the most common form of lung cancer. According to the American Cancer Society, approximately 80-85 percent of lung cancers are NSCLC. Additionally, 10-20 percent of

NSCLC patients have the epidermal growth factor receptor (EGFR) gene mutation that the newly approved cobas test identifies. “The FDA approval of the cobas® EGFR Mutation Test v2 for liquid biopsy for diagnostic use sets a standard in testing for NSCLC patients,” said Uwe Oberlaender, head of Roche Molecular Diagnostics, in the company’s announcement of the approval.

“Approvals of liquid biopsy tests make it possible to deliver highly individualized health care for patients,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, in a statement. “Liquid biopsies also have the potential to allow physicians to identify patients whose tumors have specific mutations in the least invasive way possible.” Such testing offers a new diagnostic option to patients for whom surgery would be too invasive, who can’t travel to surgical locations, or whose tumor would be difficult to surgically biopsy.

Tarceva, the drug for which the newly approved test serves as a companion diagnostic is manufactured by Astellas Pharma Technologies and distributed by Genentech, and was approved by the FDA in 2004 for patients with NSCLC after other chemotherapy failed and in 2013 as a first-line treatment for metastatic NSCLC with EGFR exon 19 deletions or L858R substitution mutations.

DTET reported last year that liquid biopsy technology “holds enormous potential to transform the medical management of oncology patients by providing noninvasive, real-time insights of disease status. Also known as a ‘molecular stethoscope,’ liquid biopsies are integral to personalizing cancer care.” It also predicted that the liquid biopsy field has the potential to quickly become a multi-billion dollar market, with some analysts predicting that it could reach $10 billion and that it could be a part of routine care within five years. See “Special Focus: Liquid Biopsies for Oncology to Gain Clinical Momentum in 2015,” Diagnostic Testing & Emerging Technologies, February 2015, p. 8.

And this year, DTET highlighted liquid biopsy as a trend to watch for 2016, explaining that 2015 was a “breakthrough year in demonstrating the clinical utility of these tests” and that 2016 promised movement towards expanding non-invasive prenatal testing to average-risk markets, clinical adoption of liquid biopsy for multiple applications in oncology monitoring, and further emergence of the technology in post-organ transplantation surveillance. See “Testing Trends to Watch for in 2016,” Diagnostic Testing & Emerging Technologies, February 2016, p. 1.

Takeaway: FDA approval of liquid biopsy companion diagnostic for lung cancer bears out predictions for increased prevalence of the less invasive testing option.