FDA approves first blood test to help diagnose concussions

Edward Hoffer ehoffer at GMAIL.COM
Sat Feb 17 01:24:08 UTC 2018


The headline is clearly misleading - the Banyan TBI is a sensitive and
apparently specific test for lesions that show up on CT - ie, contusions,
intracerebral bleeding - and as such would clearly NOT help diagnose a
concussion, which by definition has a normal CT.
What it apparently does do is allow the ED physician to avoid a CT if the
test is negative - though my concern is that it is positive "within the
first 12 hours." I could not find any information about time course - how
useful if the patient presents in, say, 6 hours after injury.
Ed
Edward P Hoffer MD, FACP, FACC

On Fri, Feb 16, 2018 at 10:57 AM, Masel, Meredith C. <mcmasel at utmb.edu>
wrote:

> From Leonard T. Wilson who is retired from the FDA as Chief, Biologics
> Device Branch (CBER).
>
> I didn’t see this in the string yet, so maybe it will help the
> conversation.
>
> Meredith
>
>
>
> [image: cid:image001.png at 01CCCFBA.4A748A40]
>
>
>
> *Meredith Masel, PhD, MSW*
>
> *The Oliver Center for Patient Safety & Quality Healthcare*
>
> 301 University Blvd., Galveston, TX 77555
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>
> M 832.496.3135 <(832)%20496-3135>
>
> *mcmasel at utmb.edu <mcmasel at utmb.edu>*
>
>
>
> [image: UTMB_Health]
>
>
>
>
>
>
>
> *From:* Leonard Wilson [mailto:leonard.t.wilson at gmail.com]
> *Sent:* Friday, February 16, 2018 9:12 AM
> *To:* Masel, Meredith C. <mcmasel at utmb.edu>
> *Subject:* Re: FW: [IMPROVEDX] FDA approves first blood test to help
> diagnose concussions
>
>
>
> Here's the FDA press release.  I'm going to try to get the package insert.
>
>
>
> UL
>
>
>
> February 14, 2018
> Release
>
> 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
> <https://na01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FDeviceRegulationandGuidance%2FHowtoMarketYourDevice%2Fucm441467.htm&data=02%7C01%7Cmcmasel%40utmb.edu%7C0a5237d1c1074ecbe94708d5754f9526%7C7bef256d85db4526a72d31aea2546852%7C0%7C0%7C636543907047435091&sdata=NokDnpbn3%2FbhNHQYawv2TR7lHU8yfiaLK%2BU%2FdAprkXQ%3D&reserved=0>
> .
>
> 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.
>
> The FDA, an agency within the U.S. Department of Health and Human
> Services, protects the public health by assuring the safety, effectiveness,
> and security of human and veterinary drugs, vaccines and other biological
> products for human use, and medical devices. The agency also is responsible
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> Page Last Updated: 02/15/2018
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>
>
>
>
> On Fri, Feb 16, 2018 at 8:38 AM, Masel, Meredith C. <mcmasel at utmb.edu>
> wrote:
>
>
>
> Meredith Masel, PhD, MSW
> Oliver Center UTMB
>
> *From:* Tom Benzoni
> *Sent:* 2/16/18, 8:32 AM
> *To:* Society to Improve Diagnosis in Medicine
>
> *Subject:* Re: [IMPROVEDX] FDA approves first blood test to help diagnose
> concussions
>
> Correct headline might be
>
> "Blood test helps find brain parenchymal damage"
>
> Reliance on this test to diagnose concussion is an interesting theory but
> that is not the question that was studied.
>
> tom
>
>
>
> On Fri, Feb 16, 2018 at 7:51 AM, Bruno, Michael <
> mbruno at pennstatehealth.psu.edu> wrote:
>
> In such cases, any false positives would be problematic, leading to
> overdiagnosis errors as well.
>
>
>
> Mike
>
>
>
>
>
> *From:* Mosher, Timothy [mailto:tmosher at PENNSTATEHEALTH.PSU.EDU]
> *Sent:* Thursday, February 15, 2018 2:19 PM
>
>
> *To:* IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG
> *Subject:* Re: [IMPROVEDX] FDA approves first blood test to help diagnose
> concussions
>
>
>
>>
> It will be interesting to see  how this test fits into the clinical
> pathway.  It sounds as though it will serve as a test to exclude
> intra-cranial hemorrhage.  If so it will need to have high sensitivity and
> NPV to avoid additional examination with CT.  A concern is that it will be
> used in patients with low probability of ICH (i.e. ones that currently
> would not undergo CT examination) leading to higher cost with relatively
> little impact on patient outcome.
>
>
> ------------------------------
>
> *From:* Grubenhoff, Joe <Joe.Grubenhoff at CHILDRENSCOLORADO.ORG>
> *Sent:* Thursday, February 15, 2018 2:05 PM
> *To:* IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG
> *Subject:* Re: [IMPROVEDX] FDA approves first blood test to help diagnose
> concussions
>
>
>
>
>
>
>
> I think if I understand the test correctly, the blood test is a test that
> suggests that there is actually intracranial bleeding (aka more than an
> isolated concussion) that would lead a clinician to be more judicious in
> the use of CT. then if the CT is ultimately negative, the dx of concussion
> would be made. So in essence the test is not a test to dx a concussion but
> more along the lines of a test to rule out more serious injury leaving
> concussion as a dx of exclusion. I think the problem is in the reporting
> and conflating separate ideas.
>
>
>
>
>
>
>
> *From: *Ruth Ryan <ruth at RYAN-GRAHAM.COM>
> *Reply-To: *Society Medicine <IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG>, Ruth
> Ryan <ruth at RYAN-GRAHAM.COM>
> *Date: *Thursday, February 15, 2018 at 11:57
> *To: *Society Medicine <IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG>
> *Subject: *Re: [IMPROVEDX] FDA approves first blood test to help diagnose
> concussions
>
>
>
> Helene, Thanks for this, it’s good to keep an eye on new diagnostic
> developments, which we could certainly use in head injury. And a skeptical
> eye at that.
>
>
>
> This article is based on a press release from the manufacturer, touting
> its FDA approval, not much of a gold standard for safety these days.
> Caution flags abound.
>
> The article states concussion may be later confirmed by CT, however CT
> does not permit diagnosis of concussion; the disruption of neural
> connections is not visible on imaging.
>
> CT can show skull fracture and intracerebral bleeding.
>
> The worst effect of a negative CT is to lull the physician and patient
> into a false sense of security, permit a missed diagnosis of concussion,
> and set the patient up for re-injury by returning to activity prematurely.
>
>
>
> Ruth Ryan RN, BSN, MSW
>
>
>
> *From:* HM Epstein [mailto:hmepstein at GMAIL.COM <hmepstein at GMAIL.COM>]
> *Sent:* Thursday, February 15, 2018 8:39 AM
> *To:* IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG
> *Subject:* [IMPROVEDX] FDA approves first blood test to help diagnose
> concussions
>
>
>
> The first blood test to help diagnose concussions is both more accurate
> than current sideline assessment tools and less expensive than CTs. But a
> positive result still needs to be confirmed by CT and 3-4 hours for results
> is too long for sideline use. So is this considered an improvement in
> diagnosis? No information in this article about the accuracy of the test
> for all concussions or whether it’s limited to just certain types of
> concussion.
> https://www.statnews.com/2018/02/14/blood-test-concussions/?
> <https://na01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.statnews.com%2F2018%2F02%2F14%2Fblood-test-concussions%2F%3Futm_source%3DSTAT%2BNewsletters%26utm_campaign%3D464ba1afae-Daily_Recap%26utm_medium%3Demail%26utm_term%3D0_8cab1d7961-464ba1afae-124972617%26utm_source%3DSTAT%2BNewsletters%26utm_campaign%3D31ff928732-MR%26utm_medium%3Demail%26utm_term%3D0_8cab1d7961-31ff928732-150508981&data=02%7C01%7Cmcmasel%40UTMB.EDU%7C5843a87dc8464954f17008d5754a489e%7C7bef256d85db4526a72d31aea2546852%7C0%7C0%7C636543884265144537&sdata=EH9hdd7pvJW%2BXwxJV0QEegJJwa5T599eyRZzLD9JBaU%3D&reserved=0>
> FDA approves first blood test to help diagnose concussions
>
> David Silverman/Getty Images
>
> *T*
>
> he Food and Drug Administration gave a green light Wednesday for the first
> time to a blood test that doctors can use to help rule out concussions
> <https://na01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.statnews.com%2F2017%2F12%2F18%2Fconcussion-diagnosis-technology%2F&data=02%7C01%7Cmcmasel%40UTMB.EDU%7C5843a87dc8464954f17008d5754a489e%7C7bef256d85db4526a72d31aea2546852%7C0%7C0%7C636543884265144537&sdata=xb%2FzEEUzjus4UaxhpvfrTxU0QGBGOj%2BfS7J6Acqc4nM%3D&reserved=0>
> .
>
> The Brain Trauma Indicator, marketed by Banyan Biomarkers Inc., measures
> the levels of two proteins — called UCH-L1 and GFAP — whose elevated
> presence suggests a certain type of brain damage normally only visible on a
> CT scan. The test takes three to four hours, and doctors could use it to
> determine which patients need a CT scan to confirm the damage and which
> patients can rest easy.
>
> In a press release, FDA Commissioner Scott Gottlieb said that this product
> could save the health care system money by preventing unnecessary
> neuroimaging tests. Additionally, by sparing some patients CT scans, it
> would reduce the radiation exposure associated with those scans.
>
> advertisement
>
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> “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 Dr. Jeffrey Shuren, director of the FDA’s Center
> for Devices and Radiological Health, in a statement. “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.”
>
> Other companies have similar tests in the works. Abbott, with funding from
> the Department of Defense is developing a blood test that searches for the
> same two proteins, Scientific American reported
> <https://na01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.scientificamerican.com%2Farticle%2Fsimple-blood-tests-for-rapid-concussion-diagnosis%2F&data=02%7C01%7Cmcmasel%40UTMB.EDU%7C5843a87dc8464954f17008d5754a489e%7C7bef256d85db4526a72d31aea2546852%7C0%7C0%7C636543884265144537&sdata=LeFAUHs4vUg%2Fy0gVSrrbMLn5%2FGb10pkBImb357njOQc%3D&reserved=0>
> last year. Hundreds
> <https://na01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.statnews.com%2F2017%2F12%2F18%2Fconcussion-diagnosis-technology%2F&data=02%7C01%7Cmcmasel%40UTMB.EDU%7C5843a87dc8464954f17008d5754a489e%7C7bef256d85db4526a72d31aea2546852%7C0%7C0%7C636543884265144537&sdata=xb%2FzEEUzjus4UaxhpvfrTxU0QGBGOj%2BfS7J6Acqc4nM%3D&reserved=0>
> of patents have been filed in recent years describing various methods to
> test for concussion.
> About the Author
>
> Ike Swetlitz
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