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Abbott's (ABT) i-STAT TBI Cartridge Receives FDA Approval
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Abbott Laboratories, Inc. (ABT - Free Report) recently announced the receipt of the FDA approval for the i-STAT TBI (traumatic brain injury) cartridge. The test runs on Abbott's portable i-STAT Alinity instrument, which uses whole blood to help assess patients with a suspected mild traumatic brain injury (mTBI) or concussion. The test delivers lab-quality results in 15 minutes.
The latest development expands Abbott's TBI test offering, fortifying its Diagnostics business.
More on for i-STAT TBI cartridge
Abbott's i-STAT TBI cartridge, in conjunction with the i-STAT Alinity System, requires a little venous blood sample to be placed on the test cartridge. The cartridge is then put into the i-STAT Alinity, a portable device. The test detects two biomarkers from the brain that may be discharged into the bloodstream, indicating brain damage.
The ability to use whole blood to assist in assessing TBI is a key step toward Abbott's goal of making its tests available in all settings where individuals seek treatment for brain injuries. Abbott is conducting ongoing research and planning that may eventually allow the test to be utilized in non-healthcare settings and with a broader population, including teenagers and pediatrics.
Benefits of FDA Approval
This FDA authorization will allow testing to be performed in a variety of new healthcare settings besides hospital emergency departments, including urgent care clinics, with a certificate to perform moderate complexity tests.
Image Source: Zacks Investment Research
A portable whole blood test allows doctors to evaluate patients aged 18 and up who have a suspected mild traumatic brain injury (mTBI). Test results can help to rule out the need for a CT scan of the head and determine the appropriate next steps in patient management. The capacity to perform the test with a full blood sample allows testing to take place in healthcare settings without a lab, accelerating the examination of head traumas.
With this approval, the i-STAT TBI test can be used to help evaluate patients up to 24 hours after injury, which is a significant advancement given that individuals injured frequently wait before seeking care.
Industry Prospects
Per Verified Market Reports, traumatic brain injury therapeutics market size was valued at $5.50 billion in 2023 and is expected to reach $14.90 billion by the end of 2030 at a CAGR of 12.7%. The increasing prevalence of traumatic brain injuries (TBIs), rising preference for minimally invasive procedures and growing awareness about the early diagnosis of brain injuries are factors that will likely fuel market growth
Progress Within Diagnostics Business
Throughout 2023, there has been increased demand for routine diagnostics, particularly in the United States and internationally.
On a global scale, Abbott currently holds a prominent position in point-of-care testing, with a portfolio focused on four key areas like Infectious Disease, Cardiometabolic & Informatics, Toxicology and Consumer Diagnostics. In the fourth quarter of 2023, organic sales (excluding COVID testing) moved up 2.2%. The company’s core laboratory diagnostics business is strengthened by the continued success of the Alinity suite of diagnostics instruments, along with a broad test menu offering.
Last month, Abbott secured FDA approval for the new GLP systems Track lab automation system that offers cutting-edge technology to help laboratories increase performance and improve the overall quality of their operations.
Price Performance
In the past year, ABT’s shares have gained 12.6% compared with the industry’s rise of 6.3%.
Zacks Rank and Key Picks
Abbott currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks from the broader medical space are Stryker Corporation (SYK - Free Report) , Cencora, Inc. (COR - Free Report) and Cardinal Health (CAH - Free Report) .
Stryker, carrying a Zacks Rank #2 (Buy), reported a fourth-quarter 2023 adjusted EPS of $3.46, beating the Zacks Consensus Estimate by 5.8%. Revenues of $5.8 billion outpaced the consensus estimate by 3.8%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Stryker has an estimated earnings growth rate of 11.5% for 2025 compared with the S&P 500’s 9.9%. The company’s earnings surpassed estimates in each of the trailing four quarters, the average being 5.1%.
Cencora, carrying a Zacks Rank #2, reported a first-quarter fiscal 2024 adjusted EPS of $3.28, which beat the Zacks Consensus Estimate by 14.7%. Revenues of $72.3 billion outpaced the Zacks Consensus Estimate by 5.1%.
COR has an earnings yield of 5.75% compared with the industry’s 1.85%. The company’s earnings surpassed estimates in each of the trailing four quarters, the average being 6.7%.
Cardinal Health, carrying a Zacks Rank #2, reported second-quarter fiscal 2024 adjusted earnings of $1.82, which beat the Zacks Consensus Estimate by 16.7%. Revenues of $57.45 billion improved 11.6% on a year-over-year basis and also topped the Zacks Consensus Estimate by 1.1%.
CAH has a long-term estimated earnings growth rate of 15.3% compared with the industry’s 11.8% growth. The company’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 15.6%.
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Abbott's (ABT) i-STAT TBI Cartridge Receives FDA Approval
Abbott Laboratories, Inc. (ABT - Free Report) recently announced the receipt of the FDA approval for the i-STAT TBI (traumatic brain injury) cartridge. The test runs on Abbott's portable i-STAT Alinity instrument, which uses whole blood to help assess patients with a suspected mild traumatic brain injury (mTBI) or concussion. The test delivers lab-quality results in 15 minutes.
The latest development expands Abbott's TBI test offering, fortifying its Diagnostics business.
More on for i-STAT TBI cartridge
Abbott's i-STAT TBI cartridge, in conjunction with the i-STAT Alinity System, requires a little venous blood sample to be placed on the test cartridge. The cartridge is then put into the i-STAT Alinity, a portable device. The test detects two biomarkers from the brain that may be discharged into the bloodstream, indicating brain damage.
The ability to use whole blood to assist in assessing TBI is a key step toward Abbott's goal of making its tests available in all settings where individuals seek treatment for brain injuries. Abbott is conducting ongoing research and planning that may eventually allow the test to be utilized in non-healthcare settings and with a broader population, including teenagers and pediatrics.
Benefits of FDA Approval
This FDA authorization will allow testing to be performed in a variety of new healthcare settings besides hospital emergency departments, including urgent care clinics, with a certificate to perform moderate complexity tests.
A portable whole blood test allows doctors to evaluate patients aged 18 and up who have a suspected mild traumatic brain injury (mTBI). Test results can help to rule out the need for a CT scan of the head and determine the appropriate next steps in patient management. The capacity to perform the test with a full blood sample allows testing to take place in healthcare settings without a lab, accelerating the examination of head traumas.
With this approval, the i-STAT TBI test can be used to help evaluate patients up to 24 hours after injury, which is a significant advancement given that individuals injured frequently wait before seeking care.
Industry Prospects
Per Verified Market Reports, traumatic brain injury therapeutics market size was valued at $5.50 billion in 2023 and is expected to reach $14.90 billion by the end of 2030 at a CAGR of 12.7%. The increasing prevalence of traumatic brain injuries (TBIs), rising preference for minimally invasive procedures and growing awareness about the early diagnosis of brain injuries are factors that will likely fuel market growth
Progress Within Diagnostics Business
Throughout 2023, there has been increased demand for routine diagnostics, particularly in the United States and internationally.
On a global scale, Abbott currently holds a prominent position in point-of-care testing, with a portfolio focused on four key areas like Infectious Disease, Cardiometabolic & Informatics, Toxicology and Consumer Diagnostics. In the fourth quarter of 2023, organic sales (excluding COVID testing) moved up 2.2%. The company’s core laboratory diagnostics business is strengthened by the continued success of the Alinity suite of diagnostics instruments, along with a broad test menu offering.
Last month, Abbott secured FDA approval for the new GLP systems Track lab automation system that offers cutting-edge technology to help laboratories increase performance and improve the overall quality of their operations.
Price Performance
In the past year, ABT’s shares have gained 12.6% compared with the industry’s rise of 6.3%.
Zacks Rank and Key Picks
Abbott currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks from the broader medical space are Stryker Corporation (SYK - Free Report) , Cencora, Inc. (COR - Free Report) and Cardinal Health (CAH - Free Report) .
Stryker, carrying a Zacks Rank #2 (Buy), reported a fourth-quarter 2023 adjusted EPS of $3.46, beating the Zacks Consensus Estimate by 5.8%. Revenues of $5.8 billion outpaced the consensus estimate by 3.8%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Stryker has an estimated earnings growth rate of 11.5% for 2025 compared with the S&P 500’s 9.9%. The company’s earnings surpassed estimates in each of the trailing four quarters, the average being 5.1%.
Cencora, carrying a Zacks Rank #2, reported a first-quarter fiscal 2024 adjusted EPS of $3.28, which beat the Zacks Consensus Estimate by 14.7%. Revenues of $72.3 billion outpaced the Zacks Consensus Estimate by 5.1%.
COR has an earnings yield of 5.75% compared with the industry’s 1.85%. The company’s earnings surpassed estimates in each of the trailing four quarters, the average being 6.7%.
Cardinal Health, carrying a Zacks Rank #2, reported second-quarter fiscal 2024 adjusted earnings of $1.82, which beat the Zacks Consensus Estimate by 16.7%. Revenues of $57.45 billion improved 11.6% on a year-over-year basis and also topped the Zacks Consensus Estimate by 1.1%.
CAH has a long-term estimated earnings growth rate of 15.3% compared with the industry’s 11.8% growth. The company’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 15.6%.