Blog Tag: Biomarker

FDA Approves Blood Test for Concussion

FDA Approves Blood Test for Concussion

The U.S. Food and Drug Administration has announced approval of Banyan Biomarkers, Inc.’s Banyan BTI (Brain Trauma Indicator) under the FDA’s De Novo premarket review pathway.   According to the press release, Banyan BTI is the first in vitro diagnostic blood test for the evaluation of mild traumatic brain injuries (mTBI), commonly referred to as concussions, authorized for marketing by the FDA.   

According to Banyan Biomarkers, more than 90 percent of patients presenting to the emergency department with mTBI receive a negative CT scan.  Banyan BTI purports to identify two brain-specific protein biomarkers that rapidly appear in the blood after a brain injury, providing information to assess patients with suspected mTBI.  According to the FDA, availability of a blood test for concussions will help health care professionals determine the need for a CT scan in patients suspected of having mTBI and help prevent unnecessary neuroimaging and associated radiation exposure to patients.

With respect to approval of Banyan BTI, FDA Commissioner Scott Gottlieb, M.D. stated:

“A blood-testing option for the evaluation of mTBI/concussion not only provides health care professionals with a new tool, but also sets the stage for a more modernized standard of care for testing of suspected cases. In addition, availability of a blood test for mTBI/concussion will likely reduce the CT scans performed on patients with concussion each year, potentially saving our health care system the cost of often unnecessary neuroimaging tests.”


First-Ever FDA Approval of Liquid Biopsy for Detecting Lung Cancer

The New York Times reports that Roche, a Swiss biotech company, recently received the first-ever FDA approval for a “liquid biopsy” test for diagnosing non-small cell lung cancer (NSCLC).  The Times reports that while the test may not be perfect, it was able to produce results that generally agree with those of an invasive tumor biopsy.  NSCLC is recognized as the most common form of lung cancer, accounting for approximately 85% of all detected lung cancers.  Therefore, the market for Roche’s test is likely robust.

According to Roche, the approved cobas® EGFR Mutation Test v2 detects mutations of epidermal growth factor receptor (EGFR) genes in a patient’s blood sample.  While oncologists have traditionally relied on medical imaging or invasive surgical biopsies to detect cancer, in an effort to avoid unnecessary biopsies and find cancer earlier, researchers are now seeking to develop tests to detect cell-free DNA biomarkers that are indicative of cancer.  Although some liquid biopsies have been commercially available for years, these DNA-based tests have long been considered a “regulatory blind spot” of the FDA.
In an FDA press release regarding the approval, Alberto Gutierrez, Director, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health at the FDA states:

Approvals of liquid biopsy tests make it possible to deliver highly individualized health care for patients.  Liquid biopsies also have the potential to allow physicians to identify patients whose tumors have specific mutations in the least invasive way possible.

The FDA specifically identified that Roche’s liquid biopsy can now be used as a blood-based companion diagnostic for Genetech’s cancer drug Tarceva (erlotinib), which was approved in 2013 as a first-line treatment for patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or L858R substitution mutations, the same genetic mutations identified by Roche’s new test.

Medical professionals appear accepting of the new technology and excited regarding the role it could fill in patient treatment – Dr. Benjamin Levy, MD, Director of Thoracic Medical Oncology at 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.