First blood test to help diagnose traumatic brain injuries gets FDA approval

U.S. health regulators have approved the first blood test to help diagnose traumatic brain injuries

The method of taking blood tests to diagnose brain injury was discovered some years ago but just yesterday the FDA approved it. If a blood testing option is available, and given the lack of discernible lesions concussion patients may have, the test may be a preferred option combined with the Glasgow Coma Scale versus a CT scan. A sizeable number do not, as the FDA points out.

The Brain Trauma Indicator was assessed under the FDA's De Novo premarket survey pathway, an administrative pathway for some low-to direct hazard gadgets that are novel and for which there is no earlier legitimately showcased gadget.

While the blood test can not now detect concussions conclusively, it does allow doctors to scan brain cells for proteins that indicate brain bleeding and other neurological injuries after a blow to the head, the Associated Press reported. The FDA reviewed and authorized for marketing the Banyan Brain Trauma Indicator in fewer than 6 months as part of its Breakthrough Devices Program. The blood test is thus expected to cut down on these unhelpful scans and the associated radiation exposure.

The move means Banyan Biomarkers can commercialize its test, giving the San Diego-based company an edge in the biotech industry's race to find a way to diagnose concussions.

FDA director Scott Gottlieb said in a press statement that the test could "ensure that each patient is getting the right imaging exam, at the right time, with the right radiation dose". The company developed the test with partial support from a contract with the U.S. Army. "The FDA's audit group worked intimately with the test engineer and the U.S. Branch of Defense to assist a blood test for the assessment of mTBI that can be utilized both in the mainland U.S. and also outside U.S. research centers that administration the American military". Elevated levels of the proteins can be detected within 15 or 20 minutes of injury. The Centers for Disease Control and Prevention has estimated that in 2013, there were roughly 2.8 million emergency department visits, hospitalizations and deaths in the USA related to traumatic brain injury, or TBI.

To address such injuries, Banyan Biomarkers has partnered Quanterix to develop another test to detect the impact of repeated hits. Those are incredibly good odds, and considering the test costs as little as one-tenth as much as a CT scan, it's a huge win for modern medicine.

"That's what we'd like to have for the brain", he said. The FDA says the Banyan test was able to predict the presence of brain injury on a CT scan 97.5 percent of the time.

FDA approved the test following a clinical study of 1,900 blood samples from people with concussion or mild traumatic brain injury.

Related news:

Hot News

isis-killer-beheading-video-story-top Trump Should Treat Women 'With More Respect', Say Bill and Melinda Gates
Feb 16, 2018 - 07:00
Wealth opens doors that are closed to most people, Melinda Gates wrote. On one level, I think the answer is obviously no.

isis-killer-beheading-video-story-top Three more flu-related deaths in Central Alberta
Feb 16, 2018 - 06:57
We like to think the days of chilling mortality rates, like those associated with the Spanish flu , are far behind us. The CDC said the flu vaccine is usually more effective against type B viruses and H1N1 than it is against H3N2.

isis-killer-beheading-video-story-top Horror luge crash stuns Winter Olympics crowd
Feb 15, 2018 - 02:44
Sweeney is just 24 years old, though, so we can hopefully count on her returning to competition for the 2022 Winter Olympics . The crash happened around Curve 9 of the track, with Sweeney having started to lose control of her sled moments before.

isis-killer-beheading-video-story-top Take it slow: linger over your lunch to lose weight, says study
Feb 15, 2018 - 02:37
The study linked changing behaviours, including eating speed, to a lower chance of obesity and a shrinking waistline. Skipping breakfast did not seem to have any effect.

isis-killer-beheading-video-story-top Nokia likely to stage smartphone comeback
Feb 15, 2018 - 02:17
HMD Global has already announced that all the Nokia smartphones will receive Android updates for a minimum of two years. The update also corrects the much talked about hamburger emoji and also includes the February Google Security Patch.

isis-killer-beheading-video-story-top Apple's Alleged Upcoming iPad May Feature Face ID Technology
Feb 15, 2018 - 02:12
Apple might also wait on rolling out some new Apple Pencil features, as well as a new toggle in the email app to mute threads. Apple has a very convincing rational behind delaying various features and adopting a new iOS release cycle.

isis-killer-beheading-video-story-top Foreign Accent Syndrome: Arizona woman awakes with a British accent
Feb 15, 2018 - 02:05
She was taken to the emergency room, where she woke up with a British accent that has been with her ever since. Michelle Myers, a mum of seven who lives in Buckeye, Arizona and has never left the United States.

isis-killer-beheading-video-story-top BT Group To Show Premier League Matches For Further Three Years
Feb 14, 2018 - 19:51
BT will continue to show games at 5.30pm on Saturdays next season and then move to Saturday lunchtime fixtures from August 2019. Sky will continue to be the chief telecaster of Premier League football after their broadcasting rights were extended to 2022.

isis-killer-beheading-video-story-top These Mardi Gras Memes & GIFs Are Hilariously True
Feb 14, 2018 - 19:50
Dining Services Executive Chef Matthew Lasof will make a tribute to his time in New Orleans with Mardi Gras night at Northside Cafe.

isis-killer-beheading-video-story-top In the business of love
Feb 14, 2018 - 19:48
Williams is long in the flower business but stops short of saying he's gotten down the Valentine's Day preparation to a science. Specialty flowers can still be ordered at local flower shops or you can pick some up at your local grocery or drug store.

isis-killer-beheading-video-story-top Canada wins Olympic figure skating gold, U.S. grabs bronze
Feb 14, 2018 - 19:48
Canada won gold with 73 points, well ahead of Olympic Athletes from Russian Federation (66), and the Americans (62). Lundby turned World Cup ski jumping domination into Olympic gold with a jump of 110 meters for 264.6 points.

isis-killer-beheading-video-story-top Hockey's Three Stars from Day 5 at the Olympics
Feb 14, 2018 - 19:46
Slovenia, playing in its second Olympic hockey tournament ever, boasts just one player with NHL experience: forward Jan Mursak. Many spent stints in the NHL - five games here, 10 more there - before turning to a journeyman career in European leagues.

isis-killer-beheading-video-story-top Russian Military Contractors Killed in US-Led Attack in Syria
Feb 14, 2018 - 19:30
President Vladimir Putin's spokesman, Dmitry Peskov, wouldn't comment on the reports either, saying they needed to be verified. The soldiers were reportedly mercenaries fighting for the Assad regime in Syria who attacked a USA held refinery/base.

isis-killer-beheading-video-story-top Apple News launches 2018 Winter Olympics features section
Feb 12, 2018 - 01:57
The company is adding a new section in Apple News that will be dedicated to the Winder Olympics in Pyeongchang. From there, the user is automatically authenticated on the app, if necessary, via the Single Sign-On feature.

isis-killer-beheading-video-story-top YouTube will downgrade discoverability of channels posting offensive content
Feb 12, 2018 - 01:57
In December, he was criticised for uploading a video of a dead body recorded in Japan's so-called suicide forest . Understandably, the video caused an outcry, and Paul took several weeks off after giving an abrupt apology.