Abbott Receives FDA Clearance for First Commercially Available Lab-based Blood Test to Help Evaluate Concussion (2024)

Abbott Receives FDA Clearance for First Commercially Available Lab-based Blood Test to Help Evaluate Concussion

  • New test will run on Abbott's Alinity® i laboratory instrument, complementing Abbott's rapid i-STAT TBI Plasma test, cleared by the FDA in 2021
  • Given the significant number of Alinity i instruments in use in labs across the U.S., Abbott's lab test will make concussion testing available to more people across the country
  • Test helps doctors evaluate patients with mild traumatic brain injury (mTBI), commonly known as concussion, by ruling out the need for a CT scan

ABBOTT PARK, Ill., March 7, 2023 /PRNewswire/ -- Abbott (NYSE: ABT) has received U.S. Food and Drug Administration clearance for what will be the first commercially available laboratory traumatic brain injury (TBI) blood test, making it widely available to hospitals in the United States. The test, which runs on Abbott's Alinity® i laboratory instrument, will provide clinicians with an objective way to quickly assess individuals with mild TBIs, also known as concussions.

Abbott's Alinity i TBI lab test offers a new reliable result in 18 minutes to help clinicians quickly assess concussion and triage patients. For those with negative results, it rules out the need for a CT scan and can eliminate wait time at the hospital. The test measures two biomarkers in the blood that, in elevated concentrations, are tightly correlated to brain injury.

For decades, standard concussion assessment has remained the same, with doctors leveraging the Glasgow Coma Scale, a subjective doctor assessment, and CT scans to detect brain tissue damage or lesions. Having a blood test available could help reduce the number of unnecessary CT scans by up to 40%, potentially reducing costs to the healthcare system and the patient as well as the amount of time they spend in the emergency department.

Millions of people in the U.S. suffer a concussion each year, but more than half of peoplewho suspect they have a concussion never get it checked.

"People sometimes minimize a hit to the head, thinking it's no big deal. Others wonder if a visit to the doctor or emergency room for a possible concussion will provide them with meaningful answers or care," said Beth McQuiston, M.D., medical director in Abbott's diagnostics business. "Now that this test will be widely available in labs across the country, medical centers will be able to offer an objective blood test than can aid in concussion assessment. That's great news for both doctors and people who are trying to find out if they have suffered a traumatic brain injury."

TBIs are caused by a bump, blow or whiplash to the head and can pose risk of both short- and long-term effects. People who experience a TBI may experience impairment of memory, movement, sensation (e.g., vision and hearing), and emotional functioning (e.g., personality changes, psychological symptoms). Effects of TBI can last anywhere from a few days post-injury or may be permanent. People who sustain a TBI are more likely to have another one – similarly to how a sprained ankle or torn ligament is more susceptible to future injury.

These effects are worsened by misdiagnosis or lack of diagnosis, so providing tools that can objectively aid in the evaluation of a TBI or concussion is essential to giving people the answers and treatment they need.

Abbott has been pioneering breakthroughs in TBI testing technology for over a decade. This FDA clearance complements Abbott's i-STAT TBI Plasma test, the first rapid blood test for concussion, which is already cleared by the FDA. With the Alinity i clearance, a TBI blood test can now be run on Abbott's high throughput Alinity i laboratory instrument. The advancement will make TBI testing more available because the Alinity i instrument is widely used in hospitals and laboratories across the U.S.

The Alinity i test can be used when a patient shows up to the hospital with a suspected mTBI within 12 hours of injury. A blood sample is drawn from the arm and sent to the lab for preparation and the test is run on the Alinity i instrument. Results are available in as little as 18 minutes and shared with the treating healthcare provider for evaluation.

Broadening the availability of the TBI blood test for use on lab-based instruments is an important step in Abbott's strategy to ensure its tests are available in all settings where people seek care for head injuries.

About Alinity i laboratory test for TBI

The Alinity i TBI test measures complementary biomarkers in blood plasma and serum- Ubiquitin C-terminal Hydrolase L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP), that, in elevated concentrations, are tightly correlated to brain injury. It provides test results with 96.7% sensitivity and 99.4% negative predictive value.

Testing for these two biomarkers in the immediate aftermath of an injury can help health care providers decide appropriate next steps and develop a plan to care for patients. The test is for use to aid in the evaluation of patients, 18 years of age or older, presenting with suspected mild traumatic brain injury (Glasgow Coma Scale score 13-15) within 12 hours of injury, to assist in determining the need for a CT (computed tomography) scan of the head.

The test previously received European Union clearance and has been available in markets outside the U.S. since 2021.

About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

Connect with us atwww.abbott.com, on LinkedIn atwww.linkedin.com/company/abbott-/, onFacebook atwww.facebook.com/Abbottand on Twitter @AbbottNews.

The i-STAT TBI blood test was developed in collaboration with the U.S. Department of Defense (DoD) – which has been dedicated to developing a solution for the objective detection and evaluation of TBI for more than a decade. The DoD, through U.S. Army Medical Research and Development Command's (USAMRDC) U.S. Army Medical Materiel Development Activity (USAMMDA), played a critical role in developing the test run on Abbott's i-STAT Alinity platform.

TheTransformingResearchandClinicalKnowledge inTraumaticBrainInjury (TRACK-TBI) research team were the first to demonstrate how this TBI blood test can be used for the benefit of TBI patients in clinical care.

SOURCE Abbott

Abbott Receives FDA Clearance for First Commercially Available Lab-based Blood Test to Help Evaluate Concussion (1)

For further information: Abbott Media, Ellen Wichman, 224-667-8522; Abbott Investor Relations, Ryan Aliff, 224-667-2299

Abbott Receives FDA Clearance for First Commercially Available Lab-based Blood Test to Help Evaluate Concussion (2024)

FAQs

Abbott Receives FDA Clearance for First Commercially Available Lab-based Blood Test to Help Evaluate Concussion? ›

FDA Clears Abbott's i-STAT Traumatic Brain Injury Whole Blood Test as Bedside Assessment. The newly cleared i-STAT TBI test can be used to help assess patients up to 24 hours after injury at patient bedside, with lab-quality results produced in 15 minutes.

Did the FDA clear Abbott's blood test for concussions? ›

ABBOTT PARK, Ill., April 1, 2024 /PRNewswire/ -- Abbott's i-STAT TBI cartridge has received clearance from the U.S. Food and Drug Administration (FDA) to be used with whole blood, allowing doctors to help assess patients with suspected concussion at the patient's bedside and obtain lab-quality results in 15 minutes.

What is the FDA blood test for concussions? ›

(NewsNation) — A new rapid blood test to help assess concussions has received approval from the U.S. Food and Drug Administration. The test is run on a portable Abbott machine called i-STAT and produces lab-quality results in 15 minutes.

How does Abbott concussion test work? ›

A small blood sample is collected from the arm within 12 hours of injury. The blood sample is processed in the lab. The test is run on either Abbott's portable i-STAT Alinity or Alinity i laboratory instrument. The instruments yield results in 15 or 18 minutes, respectively.

What is the new blood test for concussions? ›

The Alinity i TBI test has a 96.7% sensitivity rate and a 99.4% negative predictive value rate, and it can provide results within 18 minutes, according to Abbott. If the patient is examined in the local Emergency Department shortly after trauma, Abbott's Alinity i TBI test can be performed.

What is the Abbott brain injury test? ›

The i-STAT TBI Plasma test measures the level of biomarkers associated with brain injury in the blood stream to assist in determining the need for a CT scan of the head. The i-STAT TBI Plasma test is only available for use on the i-STAT Alinity instrument.

Do you need a blood test for a concussion? ›

TBI blood tests may hold promise for reducing radiation exposure from CT scans, and they are also evolving to have other promising uses. Currently a blood test is not the answer to determining whether you have a concussion.

Can concussions be detected with new blood test approved by FDA? ›

The device from Abbott Laboratories can reportedly detect if a patient has mild traumatic brain injury in just 15 minutes. A new rapid blood test that can reportedly detect brain injuries like concussions in just minutes has cleared a major hurdle toward becoming widely available for use in the U.S.

What is the gold standard for concussion testing? ›

The Balance Error Scoring System (BESS) is the current gold standard for evaluating balance, one of the best predictors of concussion.

What is the best concussion test? ›

A computerized tomography (CT) scan of the head is the standard test in adults to assess the brain right after injury. A CT scan uses a series of X-rays to obtain cross-sectional images of the skull and brain.

What are the cons of ImPACT concussion test? ›

ImPACT
  • Pros: Online program that can test many athletes at the same time. More comprehensive than the other assessments listed here.
  • Cons: Fee-based and you need a large computer lab and a quiet space. Computers require the use of a mouse. Tests take around 30 minutes to complete.
Oct 23, 2018

Are concussion tests accurate? ›

The most commonly used objective tests for the sideline diagnosis of concussion (Standardised Assessment of Concussion and modified Balance Error Scoring System) have poor diagnostic accuracy. The King-Devick test performed the best of the objective tests although it still misclassified 15% of concussions.

Is the ImPACT concussion test reliable? ›

ImPACT had strong to weak test-retest reliability over time, consistent with the results of previous studies. Reliability was greater for the visual motor speed and reaction time subscores than for the verbal and visual memory subscores.

Can a blood test detect CTE? ›

There are currently no approved biomarkers to diagnose CTE, thus it can only be confirmed through a post-mortem brain autopsy. Several imaging and cerebrospinal fluid biomarkers have shown promise in the diagnosis.

What blood tests are done for TBI? ›

Lab studies include the following: Serum levels of 2 biomarkers correlating with degree of brain injury, with GFAP more reliable up to 7 days after impact: glial fibrillary acid protein (GFAP), ubiquitin C-terminal hydrolase (UCH-L1) Complete blood count (CBC) including platelet count.

Can a blood test detect brain injury? ›

The FDA cleared a rapid blood test for mild traumatic brain injury. The test can help a medical provider determine if someone should get a CT scan in 15 minutes. Blood biomarker tests like this one can make brain injury diagnoses more objective and accessible, experts say.

What biomarkers are FDA approved for TBI? ›

In February 2018, the US Food and Drug Administration approved the use of the Brain Trauma Indicator (BTI), a ubiquitin-C-terminal-hydrolase-L1 (UCH-L1) and glial fibrillary acidic protein (GFAP) assay, for determining the clinical necessity of obtaining a head computed tomography (CT) scan in patients with mild TBI.

What is the FDA approved biomarker assessment for TBI? ›

The test, which involves blood drawn from an arm, measures two biomarkers that, in elevated concentrations, are highly indicative of brain injury, Abbott said in the release. Results can be achieved within 18 minutes to help clinicians assess concussion and triage patients.

What is the best diagnostic test for concussion? ›

Diagnostic Tests
  • CT Scans. A CT scan is a type of X-ray that creates detailed images of your tissue and internal organs. ...
  • MRI Scans. A doctor may order an MRI scan to better view the brain and determine whether there is any swelling or bleeding. ...
  • Neuropsychological Testing. ...
  • Neurodiagnostic Testing.

References

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