[No SPF Record] Re: [IMPROVEDX] FDA approves first blood test to help diagnose concussions

Rory Jaffe rjaffe at CHPSO.ORG
Thu Feb 15 19:35:56 UTC 2018


And then there’s this: J Neurotrauma. 2017 Jan 27. doi: 10.1089/neu.2016.4442.

Glial Fibrillary Acidic Protein and Ubiquitin C-Terminal Hydrolase-L1 Are Not Specific Biomarkers for Mild CT-Negative Traumatic Brain Injury.

Abstract

Glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase-L1 (UCH-L1) have been studied as potential biomarkers of mild traumatic brain injury (mTBI). We report the levels of GFAP and UCH-L1 in patients with acute orthopedic injuries without central nervous system involvement, and relate them to the type of extracranial injury, head magnetic resonance imaging (MRI) findings, and levels of GFAP and UCH-L1 in patients with CT-negative mTBI. Serum UCH-L1 and GFAP were longitudinally measured from 73 patients with acute orthopedic injury on arrival and on days 1, 2, 3, 7 after admission, and on the follow-up visit 3-10 months after the injury. The injury types were recorded, and 71% patients underwent also head MRI. The results were compared with those found in patients with CT-negative mTBI (n = 93). The levels of GFAP were higher in patients with acute orthopedic trauma than in patients with CT-negative mTBI (p = 0.026) on arrival; however, no differences were found on the following days. The levels of UCH-L1 were not significantly different between these two groups at any measured point of time. Levels of GFAP and UCH-L1 were not able to distinguish patients with CT-negative mTBI from patients with orthopedic trauma. Patients with orthopedic trauma and high levels of UCH-L1 or GFAP values may be falsely diagnosed as having a concomitant mTBI, predisposing them to unwarranted diagnostics and unnecessary brain imaging. This casts a significant doubt on the diagnostic value of GFAP and UCH-L1 in cases with mTBI.


From: Mosher, Timothy [mailto:tmosher at PENNSTATEHEALTH.PSU.EDU]
Sent: Thursday, February 15, 2018 11:19 AM
To: IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG
Subject: [No SPF Record] 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<mailto:Joe.Grubenhoff at CHILDRENSCOLORADO.ORG>>
Sent: Thursday, February 15, 2018 2:05 PM
To: IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG<mailto: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<mailto:ruth at RYAN-GRAHAM.COM>>
Reply-To: Society Medicine <IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG<mailto:IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG>>, Ruth Ryan <ruth at RYAN-GRAHAM.COM<mailto:ruth at RYAN-GRAHAM.COM>>
Date: Thursday, February 15, 2018 at 11:57
To: Society Medicine <IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG<mailto: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<mailto: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://urldefense.proofpoint.com/v2/url?u=https-3A__www.statnews.com_2018_02_14_blood-2Dtest-2Dconcussions_-3Futm-5Fsource-3DSTAT-2BNewsletters-26utm-5Fcampaign-3D464ba1afae-2DDaily-5FRecap-26utm-5Fmedium-3Demail-26utm-5Fterm-3D0-5F8cab1d7961-2D464ba1afae-2D124972617-26utm-5Fsource-3DSTAT-2BNewsletters-26utm-5Fcampaign-3D31ff928732-2DMR-26utm-5Fmedium-3Demail-26utm-5Fterm-3D0-5F8cab1d7961-2D31ff928732-2D150508981&d=DwMGaQ&c=hx0HUg_nG-xRkKlwWZeJFCbvzzw0Ym5DwdL_1FKbReI&r=ykcs2wU25yxj5BckI49bSg&m=cbgbggsarL_MCRECib3RmCdVpQhgTt6o3jW5o48L6tU&s=1n5qlVhfTCnFJCJqpZvaUeYf1GZ1W3mgkL90aLVRp0Y&e=>
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://urldefense.proofpoint.com/v2/url?u=https-3A__www.statnews.com_2017_12_18_concussion-2Ddiagnosis-2Dtechnology_&d=DwMGaQ&c=hx0HUg_nG-xRkKlwWZeJFCbvzzw0Ym5DwdL_1FKbReI&r=ykcs2wU25yxj5BckI49bSg&m=cbgbggsarL_MCRECib3RmCdVpQhgTt6o3jW5o48L6tU&s=e8V8OdiiBK8jC_6nnR4BzxfJWC4h-iZJLGDuVoNRoa0&e=>.

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<https://urldefense.proofpoint.com/v2/url?u=https-3A__www.scientificamerican.com_article_simple-2Dblood-2Dtests-2Dfor-2Drapid-2Dconcussion-2Ddiagnosis_&d=DwMGaQ&c=hx0HUg_nG-xRkKlwWZeJFCbvzzw0Ym5DwdL_1FKbReI&r=ykcs2wU25yxj5BckI49bSg&m=cbgbggsarL_MCRECib3RmCdVpQhgTt6o3jW5o48L6tU&s=YRKwuq6lxKU3jRV__nlZS7FH4zELTCFdAU7MLSP-JZM&e=> last year. Hundreds<https://urldefense.proofpoint.com/v2/url?u=https-3A__www.statnews.com_2017_12_18_concussion-2Ddiagnosis-2Dtechnology_&d=DwMGaQ&c=hx0HUg_nG-xRkKlwWZeJFCbvzzw0Ym5DwdL_1FKbReI&r=ykcs2wU25yxj5BckI49bSg&m=cbgbggsarL_MCRECib3RmCdVpQhgTt6o3jW5o48L6tU&s=e8V8OdiiBK8jC_6nnR4BzxfJWC4h-iZJLGDuVoNRoa0&e=> of patents have been filed in recent years describing various methods to test for concussion.

About the Author
Ike Swetlitz<https://urldefense.proofpoint.com/v2/url?u=https-3A__www.statnews.com_staff_ike-2Dswetlitz_&d=DwMGaQ&c=hx0HUg_nG-xRkKlwWZeJFCbvzzw0Ym5DwdL_1FKbReI&r=ykcs2wU25yxj5BckI49bSg&m=cbgbggsarL_MCRECib3RmCdVpQhgTt6o3jW5o48L6tU&s=zZcMqAEjuuqDLf1EowN2ZrM9LW1jXFZlD_7l-NCYV98&e=>
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