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    #46
    New blood test authorised by FDA to help evaluate concussion:

    https://www.fda.gov/NewsEvents/Newsr.../ucm596531.htm


    The U.S. Food and Drug Administration today permitted marketing of the first blood test to evaluate mild traumatic brain injury (mTBI), commonly referred to as concussion, in adults. The FDA reviewed and authorized for marketing the Banyan Brain Trauma Indicator in fewer than 6 months as part of its Breakthrough Devices Program.
    Most patients with a suspected head injury are examined using a neurological scale, called the 15-point Glasgow Coma Scale, followed by a computed tomography or CT scan of the head to detect brain tissue damage, or intracranial lesions, that may require treatment; however, a majority of patients evaluated for mTBI/concussion do not have detectable intracranial lesions after having a CT scan. Availability of a blood test for concussion 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.

    “Helping to deliver innovative testing technologies that minimize health impacts to patients while still providing accurate and reliable results to inform appropriate evaluation and treatment is an FDA priority. Today’s action supports the FDA’s Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging—an effort to ensure that each patient is getting the right imaging exam, at the right time, with the right radiation dose,” said FDA Commissioner Scott Gottlieb, M.D. “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.”

    According to the U.S. Centers for Disease Control and Prevention, in 2013 there were approximately 2.8 million TBI-related emergency department visits, hospitalizations and deaths in the U.S. Of these cases, TBI contributed to the deaths of nearly 50,000 people. TBI is caused by a bump, blow or jolt to the head or a penetrating head injury that disrupts the brain’s normal functioning. Its severity may range from mild to severe, with 75 percent of TBIs that occur each year being assessed as mTBIs or concussions. A majority of patients with concussion symptoms have a negative CT scan. Potential effects of TBI can include impaired thinking or memory, movement, sensation or emotional functioning.

    “A blood test to aid in concussion evaluation is an important tool for the American public and for our Service Members abroad who need access to quick and accurate tests,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “The FDA’s review team worked closely with the test developer and the U.S. Department of Defense to expedite a blood test for the evaluation of mTBI that can be used both in the continental U.S. as well as foreign U.S. laboratories that service the American military.”

    The Brain Trauma Indicator works by measuring levels of proteins, known as UCH-L1 and GFAP, that are released from the brain into blood and measured within 12 hours of head injury. Levels of these blood proteins after mTBI/concussion can help predict which patients may have intracranial lesions visible by CT scan and which won’t. Being able to predict if patients have a low probability of intracranial lesions can help health care professionals in their management of patients and the decision to perform a CT scan. Test results can be available within 3 to 4 hours.

    The FDA evaluated data from a multi-center, prospective clinical study of 1,947 individual blood samples from adults with suspected mTBI/concussion and reviewed the product’s performance by comparing mTBI/concussion blood tests results with CT scan results. The Brain Trauma Indicator was able to predict the presence of intracranial lesions on a CT scan 97.5 percent of the time and those who did not have intracranial lesions on a CT scan 99.6 percent of the time. These findings indicate that the test can reliably predict the absence of intracranial lesions and that health care professionals can incorporate this tool into the standard of care for patients to rule out the need for a CT scan in at least one-third of patients who are suspected of having mTBI.

    The Brain Trauma Indicator was reviewed under the FDA’s De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no prior legally marketed device.

    The FDA is permitting marketing of the Brain Trauma Indicator to Banyan Biomarkers, Inc
    "There are a lot of points that we’ve left behind and this is with a young group. That probably tells you what they’re capable of and that they’re a very good side.

    Probably next year or the year after next they will take some stopping"

    Anthony Foley, May 2016. Axel RIP

    Comment


      #47
      While this will certainly help determining whether the Return to play protocols are appropriate/have been successful- and might therefore help player welfare long term- the pitchside/tunnel assessment won’t be helped by this (is not like a pregnancy test you piss on and get an immediate lindication).

      Predictably, the Paris shenanigan’s inquiry exonerated everyone, with its carefully worded conclusions. I hope something is happening behind the scenes to stop teams gaming the HIA protocols- it is cynical in the extreme to abuse what is a fairly flimsy (but much needed protocol) by using its latitude to manage knee injuries. Ours is a wonderful, but potentially very harmful, game. We must protect those with the talent to play it at the highest levels (actually all levels)- not silly nanny state- but protocols based in science and respected with the honour/respect that is a hall mark of rugby. Taking the p*ss out of it, as France did is short term and horrible. Wonder what Nige thought of the report?

      Comment


        #48
        True jagawayagain, but a clear result in 3-4 hours will definitely help determine whether a player needs to be rested or not, or if they need additional treatment and RTP protocols
        "There are a lot of points that we’ve left behind and this is with a young group. That probably tells you what they’re capable of and that they’re a very good side.

        Probably next year or the year after next they will take some stopping"

        Anthony Foley, May 2016. Axel RIP

        Comment


          #49
          Originally posted by Waterfordlad View Post
          True jagawayagain, but a clear result in 3-4 hours will definitely help determine whether a player needs to be rested or not, or if they need additional treatment and RTP protocols
          Yes- and i can imagine that being done almost routinely, for every player. The in play problem remains- and in terms of any procedure likely to be able to determine whether it’s safe to play on we’re some way off a reliable system- which is why people should be punished for messing about with it, rather than covering up and condoning.

          Comment

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