clearn.png
Wednesday September 18th, 2019 1:16AM

First blood test to help diagnose brain injuries gets US OK

By The Associated Press
Related Articles
  Contact Editor

CHICAGO (AP) — The first blood test to help doctors diagnose traumatic brain injuries has won U.S. 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 U.S. 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.

"This may be a beginning. It's not the pot of gold at the end of the rainbow," Koroshetz said.

That prize would be a test that could detect and guide treatment for concussions and traumatic brain injuries, similar to a blood test that hospitals commonly use to evaluate suspected heart attacks, Koroshetz said.

"That's what we'd like to have for the brain," he said.

San Diego-based Banyan has partnered with French firm bioMerieux SA to market the test to hospitals using bioMerieux's blood analyzing machines.

Other companies are developing similar blood tests to detect brain injuries. Abbott has licensed both protein biomarkers from Banyan and is developing its own blood tests. BioDirection is developing a test involving one of the proteins in Banyan's test plus another one and using a portable device that can yield results from a single drop of blood in less than two minutes.

Quanterix is also working to develop a blood test to diagnose concussions and other brain injuries. It has licensed the use of both proteins in Banyan's test to be used with its own technology.

___

Follow AP Medical Writer Lindsey Tanner on Twitter at @LindseyTanner. Her work can be found here .

  • Associated Categories: U.S. News, Associated Press (AP), AP National News, Top U.S. News short headlines, AP Health, AP Business, AP Business - Corporate News, AP Business - Industries, AP Business - Health Care
© Copyright 2019 AccessWDUN.com
All rights reserved. This material may not be published, broadcast, rewritten, or redistributed without permission.
Watchdog's report faults VA chief over Europe trip expenses
An internal watchdog's investigation has found that Veterans Affairs Secretary David Shulkin improperly accepted Wimbledon tennis tickets and his staff doctored emails to justify his wife accompanying him at taxpayer expense on an 11-day European trip
2:21PM ( 4 minutes ago )
Berkeley declares it's a sanctuary city for marijuana users
Berkeley has declared itself a sanctuary city for marijuana users, a largely symbolic move that bars city employees from assisting federal officials in marijuana enforcement
2:13PM ( 12 minutes ago )
The Latest: 7-time champion Johnson has no retirement plan
Seven-time champion Jimmie Johnson has no retirement date in sight
2:11PM ( 14 minutes ago )
Associated Press (AP)
APNewsBreak: Dems say Interior boss is withholding key facts
Two Democratic congressmen are accusing Interior Secretary Ryan Zinke of withholding key information from lawmakers while launching a massive overhaul of his department
1:54PM ( 31 minutes ago )
AP sources: Mitt Romney to launch Senate campaign Thursday
AP sources: Former GOP presidential nominee Mitt Romney is running for the Senate in Utah
1:51PM ( 35 minutes ago )
Pot-users want judge to declare marijuana safe under US law
Federal judge in New York to hear arguments in lawsuit that targets federal marijuana laws
1:47PM ( 38 minutes ago )
AP National News
A Westminster wow: Bichon frise becomes America's top dog
Flynn the bichon frise was picked as best in show at the Westminster Kennel Club, a choice that seemed to surprise the crowd at Madison Square Garden
12:27PM ( 1 hour ago )
Official: Suspect in Chicago police death was heavily armed
A Chicago police official says a police commander who was killed after a foot chase downtown was shot in the head by a suspect carrying a semi-automatic handgun equipped with an extended clip of ammunition
11:13AM ( 3 hours ago )
Golfer Bill Haas escapes serious injury in crash; 1 killed
Golf pro Bill Haas was a passenger in a car involved in a rollover crash in Los Angeles that killed the driver of the Ferrari he was riding in and injured another driver
11:08AM ( 3 hours ago )
Top U.S. News short headlines
Stocks climb as investors shake off inflation worries
U.S. stocks are rising Wednesday, led by banks, technology companies and retailers and other confused-focused companies
1:16PM ( 1 hour ago )
$30 billion pledged in Kuwait at summit to rebuild Iraq
International donors have pledged $30 billion to help rebuild Iraq after the war against the Islamic State group
12:50PM ( 1 hour ago )
Rise in core consumer prices stokes inflation fears
US core consumer prices rose 0.3 percent in January, the most in a year as inflation fears intensify
11:59AM ( 2 hours ago )
AP Business
Watchdog's report faults VA chief over Europe trip expenses
An internal watchdog's investigation has found that Veterans Affairs Secretary David Shulkin improperly accepted Wimbledon tennis tickets and his staff doctored emails to justify his wife accompanying him at taxpayer expense on an 11-day European trip
2:21PM ( 4 minutes ago )
Berkeley declares it's a sanctuary city for marijuana users
Berkeley has declared itself a sanctuary city for marijuana users, a largely symbolic move that bars city employees from assisting federal officials in marijuana enforcement
2:13PM ( 12 minutes ago )
The Latest: 7-time champion Johnson has no retirement plan
Seven-time champion Jimmie Johnson has no retirement date in sight
2:11PM ( 14 minutes ago )
Porn star who alleged Trump affair: I can now tell my story
The porn star whom President Donald Trump's longtime personal attorney acknowledged paying $130,000 just before Election Day believes she is now free to discuss her alleged sexual encounter with the president
2:11PM ( 15 minutes ago )
French court acquits 1 man, convicts 2 in terror-tied trial
A French court on Wednesday acquitted a man charged with harboring Islamic extremists after they carried out the 2015 Paris attacks, in the first trial related to the country's deadliest extremist violence since World War II
2:07PM ( 19 minutes ago )