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Abbott (ABT) Gets FDA Nod for Alinity I Laboratory Test
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Abbott Laboratories, Inc. (ABT - Free Report) recently announced the receipt of the FDA approval for the Alinity i laboratory traumatic brain injury (TBI) blood test. This will be the first commercially available TBI blood test widely available to hospitals in the United States.
The recent development is likely to bolster Abbott’s Medical Device business.
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.
The test runs on Abbott's Alinity i laboratory instrument and helps clinicians to rapidly evaluate individuals with mild TBIs, also known as concussions.
Abbott's Alinity i TBI lab test provides a new reliable result in 18 minutes to support clinicians in quickly assessing concussion and triaging patients. The test measures two biomarkers in the blood that, in elevated concentrations, are tightly correlated to brain injury.
Benefits of Alinity i Laboratory Test
Per Abbott’s management, with the availability of this test in labs across the country, medical centers will be able to provide an objective blood test that can support concussion assessment. This will benefit doctors and people who are trying to find out if they have suffered a traumatic brain injury.
With the Alinity i FDA approval, a TBI blood test can now be run on Abbott's high throughput Alinity i laboratory instrument. The development will make TBI testing more available because the Alinity i instrument is widely used in hospitals and laboratories across the United States.
Image Source: Zacks Investment Research
Moreover, expanding the availability of the TBI blood test for lab-based instruments is a significant step in Abbott's strategy to ensure its tests are available in all locations where people need care for head injuries.
Industry Prospects
Per Grand View Research report, the global traumatic brain injuries assessment and management devices market size was $2.89 billion in 2021 and is expected to grow at a CAGR of 7.5% by 2030. The increasing prevalence of TBIs, rising patients’ preference for minimally invasive procedures and rising awareness regarding brain injury treatment are the factors driving the market.
Recent Developments
This month, Abbott presented late-breaking data from the Landmark COAPT trial for MitraClip, demonstrating the device’s long-term benefits in patients fighting heart failure. The five-year results from the landmark COAPT trial demonstrated that MitraClip is safe, effective and can reduce hospitalizations while improving survival for heart failure patients with severe secondary (or functional) MR.
This month, Abbott announced significant progress with Navitor, the company’s latest-generation transcatheter aortic valve implantation (TAVI) system. Results from this study supported Navitor's recent FDA approval to treat people with severe aortic stenosis who are at high or extreme risk for open-heart surgery.
Price Performance
Shares of the company have lost 15.5% in the past six months compared with the industry’s fall of 37.4%.
Zacks Rank and Key Picks
Currently, Abbott carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the overall healthcare sector include Haemonetics Corporation (HAE - Free Report) , TerrAscend Corp. and Akerna Corp. . Haemonetics and TerrAscend both sport a Zacks Rank #1, while Akerna carries a Zack Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
HAE’s earnings beat estimates in each of the last four quarters, delivering an average surprise of 10.98%. In the last reported quarter, it reported an earnings surprise of 7.59%.
Estimates for TerrAscend in 2023 have remained constant at a loss of 10 cents per share in the past 30 days. Shares of TerrAscend have declined 70.6% in the past year.
TerrAscend’s earnings beat estimates in one of the last three quarters and missed the mark in the other two, the average negative surprise being 136.11%. In the last reported quarter, TRSSF delivered an earnings surprise of 216.67%.
Akerna’s stock declined 95.7% in the past year. Its estimates for 2023 have remained constant at a loss of $1.91 per share over the past 30 days.
Akerna missed earnings estimates in each of the last four quarters, reporting a negative earnings surprise of 15.49%, on average. In the last reported quarter, KERN delivered a negative earnings surprise of 13.33%.
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Abbott (ABT) Gets FDA Nod for Alinity I Laboratory Test
Abbott Laboratories, Inc. (ABT - Free Report) recently announced the receipt of the FDA approval for the Alinity i laboratory traumatic brain injury (TBI) blood test. This will be the first commercially available TBI blood test widely available to hospitals in the United States.
The recent development is likely to bolster Abbott’s Medical Device business.
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.
The test runs on Abbott's Alinity i laboratory instrument and helps clinicians to rapidly evaluate individuals with mild TBIs, also known as concussions.
Abbott's Alinity i TBI lab test provides a new reliable result in 18 minutes to support clinicians in quickly assessing concussion and triaging patients. The test measures two biomarkers in the blood that, in elevated concentrations, are tightly correlated to brain injury.
Benefits of Alinity i Laboratory Test
Per Abbott’s management, with the availability of this test in labs across the country, medical centers will be able to provide an objective blood test that can support concussion assessment. This will benefit doctors and people who are trying to find out if they have suffered a traumatic brain injury.
With the Alinity i FDA approval, a TBI blood test can now be run on Abbott's high throughput Alinity i laboratory instrument. The development will make TBI testing more available because the Alinity i instrument is widely used in hospitals and laboratories across the United States.
Moreover, expanding the availability of the TBI blood test for lab-based instruments is a significant step in Abbott's strategy to ensure its tests are available in all locations where people need care for head injuries.
Industry Prospects
Per Grand View Research report, the global traumatic brain injuries assessment and management devices market size was $2.89 billion in 2021 and is expected to grow at a CAGR of 7.5% by 2030. The increasing prevalence of TBIs, rising patients’ preference for minimally invasive procedures and rising awareness regarding brain injury treatment are the factors driving the market.
Recent Developments
This month, Abbott presented late-breaking data from the Landmark COAPT trial for MitraClip, demonstrating the device’s long-term benefits in patients fighting heart failure. The five-year results from the landmark COAPT trial demonstrated that MitraClip is safe, effective and can reduce hospitalizations while improving survival for heart failure patients with severe secondary (or functional) MR.
This month, Abbott announced significant progress with Navitor, the company’s latest-generation transcatheter aortic valve implantation (TAVI) system. Results from this study supported Navitor's recent FDA approval to treat people with severe aortic stenosis who are at high or extreme risk for open-heart surgery.
Price Performance
Shares of the company have lost 15.5% in the past six months compared with the industry’s fall of 37.4%.
Zacks Rank and Key Picks
Currently, Abbott carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the overall healthcare sector include Haemonetics Corporation (HAE - Free Report) , TerrAscend Corp. and Akerna Corp. . Haemonetics and TerrAscend both sport a Zacks Rank #1, while Akerna carries a Zack Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Haemonetics’ stock has risen 42.1% in the past year. Earnings Estimates for Haemonetics have increased from $2.87 per share to 2.91 for 2023 and from $3.02 per share to $3.28 for 2024 in the past 30 days.
HAE’s earnings beat estimates in each of the last four quarters, delivering an average surprise of 10.98%. In the last reported quarter, it reported an earnings surprise of 7.59%.
Estimates for TerrAscend in 2023 have remained constant at a loss of 10 cents per share in the past 30 days. Shares of TerrAscend have declined 70.6% in the past year.
TerrAscend’s earnings beat estimates in one of the last three quarters and missed the mark in the other two, the average negative surprise being 136.11%. In the last reported quarter, TRSSF delivered an earnings surprise of 216.67%.
Akerna’s stock declined 95.7% in the past year. Its estimates for 2023 have remained constant at a loss of $1.91 per share over the past 30 days.
Akerna missed earnings estimates in each of the last four quarters, reporting a negative earnings surprise of 15.49%, on average. In the last reported quarter, KERN delivered a negative earnings surprise of 13.33%.