FDA approves first blood test to help diagnose concussions

Tom Benzoni benzonit at GMAIL.COM
Thu Feb 15 22:44:18 UTC 2018


Concussion is a clinical diagnosis, based on history and physical.
CT is a picture.
This test predicts a negative CT.
The only purpose for a CT is to tell the neurosurgeon: "Drill here."
Concussion is found first by history; application of force to head/body
causing (hopefully) temporary derangement in function.
Next is skilled physical exam.
In these settings, the CT is likely normal while the neuropshych exam is
abnormal.

Tom

On Thu, Feb 15, 2018 at 1:18 PM, Mosher, Timothy <
tmosher at pennstatehealth.psu.edu> wrote:

> ​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]
> *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://www.statnews.com/2018/02/14/blood-test-concussions/?utm_source=STAT+Newsletters&utm_campaign=464ba1afae-Daily_Recap&utm_medium=email&utm_term=0_8cab1d7961-464ba1afae-124972617&utm_source=STAT+Newsletters&utm_campaign=31ff928732-MR&utm_medium=email&utm_term=0_8cab1d7961-31ff928732-150508981>
> FDA approves first blood test to help diagnose concussions
>
> [image: Image removed by sender.]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://www.statnews.com/2017/12/18/concussion-diagnosis-technology/>.
>
> 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://www.scientificamerican.com/article/simple-blood-tests-for-rapid-concussion-diagnosis/>
> last year. Hundreds
> <https://www.statnews.com/2017/12/18/concussion-diagnosis-technology/> of
> patents have been filed in recent years describing various methods to test
> for concussion.
> About the Author
>
> Ike Swetlitz <https://www.statnews.com/staff/ike-swetlitz/>
>
> Ike is a Washington correspondent, reporting at the intersection of life
> science and national politics.
>
>
>
>       [image: Image removed by sender.]
>
> Website <http://hmepstein.com/> Twitter <https://twitter.com/hmepstein>
>
> LinkedIn <https://www.linkedin.com/in/helenekepstein/>
>
>>
> Facebook <https://www.facebook.com/HeleneEpsteinAuthor>
>
>
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Moderator: David Meyers, Board Member, Society to Improve Diagnosis in Medicine


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