[EXTERNAL] Re: [IMPROVEDX] [Marketing] [IMPROVEDX] FDA approves first blood test to help diagnose concussions

Wolford, Robert W. Robert.W.Wolford at OSFHEALTHCARE.ORG
Thu Feb 15 17:17:57 UTC 2018


More importantly, is this test actually needed?  Will it add value?

Robert W. Wolford, M.D., M.M.M., CMQ
Director of Quality and Process Improvement
Department of Emergency Medicine
OSF Saint Francis Medical Center
530 NE Glen Oak Avenue | Peoria, IL | 61637
Office:  (309) 655-2793

“Serving with the Greatest Care and Love.”






On Feb 15, 2018, at 11:09 AM, Jackson, Brian <brian.jackson at ARUPLAB.COM<mailto:brian.jackson at ARUPLAB.COM>> wrote:

Usually tests such as these first enter the market in the FDA  "moderately complex" category, which pretty much requires that they be performed in a clinical laboratory by trained staff.  Getting a test into a "waived" category so that it can be used by non-laboratory staff (think glucometers or home pregnancy tests here) is a much higher bar.  I haven't been able to find any info on the internet regarding the specific platform of this particular test, so I'm guessing it's likely to be lab-only for the immediate future.  And it will take at least a few years and lots of clinical studies before we'll know whether this will make an important contribution to concussion detection or not.  Let alone whether it can be developed into a point-of-care instrument for use on the sidelines.

--Brian
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From: HM Epstein <hmepstein at GMAIL.COM<mailto:hmepstein at GMAIL.COM>>
Sent: Thursday, February 15, 2018 6:39:19 AM
To: IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG<mailto:IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG>
Subject: [Marketing] [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://clicktime.symantec.com/a/1/evI4rqJCTU4ehUcmr-Ix2bRGMhKLevYbbga4zByFQh8=?d=UNy1odI_O_4VtUJRd0LiLUIXQkeSs7W-Dl7T9sGlxLunx0HiZzZBKVDWC8PukNUnFXlEDOV1NIsGwLtvfvL5pCV7uVm-5V2WT1bRDp8idBhsvLKxLE5FFDRWSrmwANW6lRsCi5xCFeGdymtBKn4bUjxfpYpM6beesl2m__OkSKbIuB4E1FXAE0WDpgpksFk513BnyW5i-CWg8iWWS-FjoOV2TnVBcwsNpTqdoCnjS9GLhTLPsW2g_UOoISAgostCc4pxEreexrif1N9KdauR8dEOp7kV6t_-yvpkuFAx2fUfZSNsr0GN-bgIbsWdg23jxyZdfW-Yk3fQUkcOXREt9Nuu1Tegxi4n7WVIfnVhcEx0woWcgFaaG1KyyVa1U3xkzEObNk1OEHFo91Yss61bp22orf-Mg47KekezYAcIbsC0RtKayJnMbLNeWG6hIbhwEpk%3D&u=https%3A%2F%2Fwww.statnews.com%2F2018%2F02%2F14%2Fblood-test-concussions%2F%3Futm_source%3DSTAT%2BNewsletters%26amp%3Butm_campaign%3D464ba1afae-Daily_Recap%26amp%3Butm_medium%3Demail%26amp%3Butm_term%3D0_8cab1d7961-464ba1afae-124972617%26amp%3Butm_source%3DSTAT%2BNewsletters%26amp%3Butm_campaign%3D31ff928732-MR%26amp%3Butm_medium%3Demail%26amp%3Butm_term%3D0_8cab1d7961-31ff928732-150508981>
FDA approves first blood test to help diagnose concussions
[https://www.statnews.com/wp-content/uploads/2017/07/GettyImages-56646485-645x645.jpg]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://clicktime.symantec.com/a/1/_I8sV6sN1wYbhl4v19ED9hEEGPWWcecuFWBb6lV_Ovk=?d=UNy1odI_O_4VtUJRd0LiLUIXQkeSs7W-Dl7T9sGlxLunx0HiZzZBKVDWC8PukNUnFXlEDOV1NIsGwLtvfvL5pCV7uVm-5V2WT1bRDp8idBhsvLKxLE5FFDRWSrmwANW6lRsCi5xCFeGdymtBKn4bUjxfpYpM6beesl2m__OkSKbIuB4E1FXAE0WDpgpksFk513BnyW5i-CWg8iWWS-FjoOV2TnVBcwsNpTqdoCnjS9GLhTLPsW2g_UOoISAgostCc4pxEreexrif1N9KdauR8dEOp7kV6t_-yvpkuFAx2fUfZSNsr0GN-bgIbsWdg23jxyZdfW-Yk3fQUkcOXREt9Nuu1Tegxi4n7WVIfnVhcEx0woWcgFaaG1KyyVa1U3xkzEObNk1OEHFo91Yss61bp22orf-Mg47KekezYAcIbsC0RtKayJnMbLNeWG6hIbhwEpk%3D&u=https%3A%2F%2Fwww.statnews.com%2F2017%2F12%2F18%2Fconcussion-diagnosis-technology%2F>.
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://clicktime.symantec.com/a/1/RuObC8VuFRzfV99Mz6FEugzEF3U1L0XSrW9EoSeBUXM=?d=UNy1odI_O_4VtUJRd0LiLUIXQkeSs7W-Dl7T9sGlxLunx0HiZzZBKVDWC8PukNUnFXlEDOV1NIsGwLtvfvL5pCV7uVm-5V2WT1bRDp8idBhsvLKxLE5FFDRWSrmwANW6lRsCi5xCFeGdymtBKn4bUjxfpYpM6beesl2m__OkSKbIuB4E1FXAE0WDpgpksFk513BnyW5i-CWg8iWWS-FjoOV2TnVBcwsNpTqdoCnjS9GLhTLPsW2g_UOoISAgostCc4pxEreexrif1N9KdauR8dEOp7kV6t_-yvpkuFAx2fUfZSNsr0GN-bgIbsWdg23jxyZdfW-Yk3fQUkcOXREt9Nuu1Tegxi4n7WVIfnVhcEx0woWcgFaaG1KyyVa1U3xkzEObNk1OEHFo91Yss61bp22orf-Mg47KekezYAcIbsC0RtKayJnMbLNeWG6hIbhwEpk%3D&u=https%3A%2F%2Fwww.scientificamerican.com%2Farticle%2Fsimple-blood-tests-for-rapid-concussion-diagnosis%2F> last year. Hundreds<https://clicktime.symantec.com/a/1/_I8sV6sN1wYbhl4v19ED9hEEGPWWcecuFWBb6lV_Ovk=?d=UNy1odI_O_4VtUJRd0LiLUIXQkeSs7W-Dl7T9sGlxLunx0HiZzZBKVDWC8PukNUnFXlEDOV1NIsGwLtvfvL5pCV7uVm-5V2WT1bRDp8idBhsvLKxLE5FFDRWSrmwANW6lRsCi5xCFeGdymtBKn4bUjxfpYpM6beesl2m__OkSKbIuB4E1FXAE0WDpgpksFk513BnyW5i-CWg8iWWS-FjoOV2TnVBcwsNpTqdoCnjS9GLhTLPsW2g_UOoISAgostCc4pxEreexrif1N9KdauR8dEOp7kV6t_-yvpkuFAx2fUfZSNsr0GN-bgIbsWdg23jxyZdfW-Yk3fQUkcOXREt9Nuu1Tegxi4n7WVIfnVhcEx0woWcgFaaG1KyyVa1U3xkzEObNk1OEHFo91Yss61bp22orf-Mg47KekezYAcIbsC0RtKayJnMbLNeWG6hIbhwEpk%3D&u=https%3A%2F%2Fwww.statnews.com%2F2017%2F12%2F18%2Fconcussion-diagnosis-technology%2F> of patents have been filed in recent years describing various methods to test for concussion.
About the Author
Ike Swetlitz<https://clicktime.symantec.com/a/1/S9qJTVhQGH_S-nSwwwiu7FV01eV39hSh-wi0Qfjfm9c=?d=UNy1odI_O_4VtUJRd0LiLUIXQkeSs7W-Dl7T9sGlxLunx0HiZzZBKVDWC8PukNUnFXlEDOV1NIsGwLtvfvL5pCV7uVm-5V2WT1bRDp8idBhsvLKxLE5FFDRWSrmwANW6lRsCi5xCFeGdymtBKn4bUjxfpYpM6beesl2m__OkSKbIuB4E1FXAE0WDpgpksFk513BnyW5i-CWg8iWWS-FjoOV2TnVBcwsNpTqdoCnjS9GLhTLPsW2g_UOoISAgostCc4pxEreexrif1N9KdauR8dEOp7kV6t_-yvpkuFAx2fUfZSNsr0GN-bgIbsWdg23jxyZdfW-Yk3fQUkcOXREt9Nuu1Tegxi4n7WVIfnVhcEx0woWcgFaaG1KyyVa1U3xkzEObNk1OEHFo91Yss61bp22orf-Mg47KekezYAcIbsC0RtKayJnMbLNeWG6hIbhwEpk%3D&u=https%3A%2F%2Fwww.statnews.com%2Fstaff%2Fike-swetlitz%2F>
Ike is a Washington correspondent, reporting at the intersection of life science and national politics.


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