FDA approves first blood test to help diagnose concussions

Masel, Meredith C. mcmasel at UTMB.EDU
Fri Feb 16 15:57:08 UTC 2018


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



Meredith Masel, PhD, MSW
The Oliver Center for Patient Safety & Quality Healthcare
301 University Blvd., Galveston, TX 77555-1107
P 409.747.6009 F 409.747.6010
M 832.496.3135
mcmasel at utmb.edu

[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 for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Page Last Updated: 02/15/2018


On Fri, Feb 16, 2018 at 8:38 AM, Masel, Meredith C. <mcmasel at utmb.edu<mailto: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<mailto: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<mailto:tmosher at PENNSTATEHEALTH.PSU.EDU>]
Sent: Thursday, February 15, 2018 2:19 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


​

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://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.

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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
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