FDA approves first blood test to help diagnose concussions

Grubenhoff, Joe Joe.Grubenhoff at CHILDRENSCOLORADO.ORG
Thu Feb 15 19:05:36 UTC 2018


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 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

SPONSOR CONTENT

FREE DOWNLOAD | More time to think: How a $12 billion biotech startup rooted out inefficiencies & freed up its researchers’ time

Empower your team to get what they need, when they need it, while maintaining transparency and consistent data.

“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 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>

________________________________

Address messages to: IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG<mailto:IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG>

To unsubscribe from IMPROVEDX: click the following link:
http://list.improvediagnosis.org/scripts/wa-IMPDIAG.exe?SUBED1=IMPROVEDX&A=1
or send email to: IMPROVEDX-SIGNOFF-REQUEST at LIST.IMPROVEDIAGNOSIS.ORG<mailto:IMPROVEDX-SIGNOFF-REQUEST at LIST.IMPROVEDIAGNOSIS.ORG>

Visit the searchable archives or adjust your subscription at: http://list.improvediagnosis.org/scripts/wa-IMPDIAG.exe?INDEX

Moderator:David Meyers, Board Member, Society for Improving Diagnosis in Medicine

To learn more about SIDM visit:
http://www.improvediagnosis.org/

________________________________

Address messages to: IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG

To unsubscribe from IMPROVEDX: click the following link:
http://list.improvediagnosis.org/scripts/wa-IMPDIAG.exe?SUBED1=IMPROVEDX&A=1
or send email to: IMPROVEDX-SIGNOFF-REQUEST at LIST.IMPROVEDIAGNOSIS.ORG

Visit the searchable archives or adjust your subscription at: http://list.improvediagnosis.org/scripts/wa-IMPDIAG.exe?INDEX

Moderator:David Meyers, Board Member, Society for Improving Diagnosis in Medicine

To learn more about SIDM visit:
http://www.improvediagnosis.org/
------------------------------------------------------------------------------
CONFIDENTIALITY NOTICE:  This e-mail, including any attachments, is for the sole use of the intended recipient and may contain confidential and privileged information.  If you are not an intended recipient, or the person responsible for delivering this message to an intended recipient, you are hereby notified that reading, copying, using or distributing this message is prohibited. If you are not an intended recipient, please contact the sender by reply email and destroy all copies of the original message from your computer system.

------------------------------------------------------------------------------


To unsubscribe from the IMPROVEDX:
mail to:IMPROVEDX-SIGNOFF-REQUEST at LIST.IMPROVEDIAGNOSIS.ORG
or click the following link: IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG

Address messages to: IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG

For additional information and subscription commands, visit:
http://www.lsoft.com/resources/faq.asp#4A

http://LIST.IMPROVEDIAGNOSIS.ORG/ (with your password)

Visit the searchable archives or adjust your subscription at:
http://list.improvediagnosis.org/scripts/wa-IMPDIAG.exe?INDEX

Moderator: David Meyers, Board Member, Society to Improve Diagnosis in Medicine

To unsubscribe from the IMPROVEDX list, click the following link:<br>
<a href="http://list.improvediagnosis.org/scripts/wa-IMPDIAG.exe?SUBED1=IMPROVEDX&A=1" target="_blank">http://list.improvediagnosis.org/scripts/wa-IMPDIAG.exe?SUBED1=IMPROVEDX&A=1</a>
</p>

HTML Version:
URL: <../attachments/20180215/59afcaf4/attachment.html>


More information about the Test mailing list