FDA approves first blood test to help diagnose concussions

HM Epstein hmepstein at GMAIL.COM
Fri Feb 16 01:06:16 UTC 2018

Thank you Ruth. So what is the gold standard for diagnosing the various levels of concussion?

On Feb 15, 2018, at 1:35 PM, Ruth Ryan <ruth at ryan-graham.com> wrote:

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
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.
FDA approves first blood test to help diagnose concussions
David Silverman/Getty Images

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.

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.



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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 last year. Hundreds of patents have been filed in recent years describing various methods to test for concussion.

About the Author

Ike Swetlitz
Ike is a Washington correspondent, reporting at the intersection of life science and national politics.

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