US OKs blood test to diagnose brain injuries

Woman who got attention by giving birth to 7 kids has died

Michael Catania, vice-president of product development, holds up a patient sample at Banyan Biomarkers on Feb 13 in San Diego. (AP)

CHICAGO, Feb 15, (AP): The first blood test to help doctors diagnose traumatic brain injuries has won US government approval.

The move means Banyan Biomarkers can commercialize its test, giving the company an early lead in the biotech industry’s race to find a way to diagnose concussions.

The test doesn’t detect concussions and the approval won’t immediately change how patients with suspected concussions or other brain trauma are treated. But Wednesday’s green light by the Food and Drug Administration “is a big deal because then it opens the door and accelerates technology”, said Michael McCrea, a brain injury expert at Medical College of Wisconsin.

The test detects two proteins present in brain cells that can leak into the bloodstream following a blow to the head. Banyan’s research shows the test can detect them within 12 hours of injury. It’s designed to help doctors quickly determine which patients with suspected concussions may have brain bleeding or other brain injury.

Patients with a positive test would need a CT scan to confirm the results and determine if surgery or other treatment is needed. The test will first be used in emergency rooms, possibly as soon as later this year, but Banyan’s hope is that it will eventually be used on battlefields and football fields.

FDA Commissioner Dr Scott Gottlieb said the test fits with the agency’s goals for delivering new technologies to patients and reducing unnecessary radiation exposure.

The test “sets the stage for a more modernized standard of care for testing of suspected cases”, Gottlieb said in a statement.

Traumatic brain injuries affect an estimated 10 million people globally each year; at least 2 million of them are treated in US emergency rooms. They often get CT scans to detect bleeding or other abnormalities. The scans expose patients to radiation, but in many patients with mild brain injuries including concussions, abnormalities don’t show up on these imaging tests.

With Department of Defense funding, Banyan’s research shows its Brain Trauma Indicator can accurately pick up brain trauma later found on CT scans. It also shows that absence of the two proteins in the test is a good indication that CT scans will be normal. That means patients with negative blood tests can avoid CT scans and unnecessary radiation exposure, said Dr Jeffrey Bazarian, a University of Rochester emergency medicine professor involved in Banyan’s research.

Bazarian called the test “a huge step” toward devising a blood test that can detect brain injuries including concussions.

Dr Walter Koroshetz, director of the National Institute of Neurological Disorders and Stroke, and other brain injury experts say the test isn’t sensitive enough to rule out concussions.

SAN DIEGO:

Also:

Patricia Frustaci, who made national headlines in 1985 when she gave birth to seven children but struggled with the financial and publicity fallout and with the heartache of seeing four babies perish, has died. She was 63.

Frustaci, who suffered from pulmonary fibrosis, died Saturday at a San Diego hospital, her eldest son, Joseph Frustaci of San Diego, said Wednesday.

Frustaci was an English teacher in Riverside and the mother of Joseph when she gave birth after undergoing fertility treatments. At the time, it was the largest multiple birth in the United States.