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#ABBOTT ISTAT FDA APPROVAL PORTABLE#

The CEO of Abbott says, "Point-of-care testing remains an attractive growth segment within the in vitro diagnostics market, and the acquisition of Alere will significantly expand our diagnostics presence and leadership in that space." Based on the amended terms, the company will pay $51 per share to acquire Alere for a new total price of about $5.3 billion, which is less than the original purchase price of around $5.8 billion proposed in February 2016. Abbott had agreed to amend the existing terms of an agreement to acquire Alere.

Point-of-care revenues were $135 million, up 8 percent from $125 millionĪbbott's acquisition of Alere was in the news recently.

Molecular revenues were $112 million, up 4 percent from $108 million.

Core laboratory revenues were $911 million, up 3 percent from $885 million in the prior-year quarter.

However, diagnostics sales of $1.16 billion are reported, which is up 4 percent from $1.12 billion in Q1 2016.Īccording to the report, within Diagnostics. In general, Abbott has reported overall Q1 revenues of $6.34 billion, which is 30 percent more on a reported basis from Q1 last year. This amazing growth is driven by considerable increase in core laboratory and point-of-care sales. The company recently reported that the first quarter sales in its diagnostics business grew 4% year over year. Abbott, a global healthcare company is dedicated to providing a broad range of innovative instrument systems and tests for hospitals, reference labs, physician offices and clinics.

#ABBOTT ISTAT FDA APPROVAL PORTABLE#

The agency has been collaborating with Abbott since 2014 to work on portable blood tests to help evaluate potential concussions.īanyan Biomarkers received marketing approval from the FDA for a blood test using the same biomarkers to evaluate mild TBIs in 2018, but an Abbott spokesperson noted via email that the Alinity I test is the first commercially available lab test and will mark "the first time people will have access to a concussion blood test in the. The US Department of Defense awarded the company $35.2 million in 2019 to develop a TBI assay. "Now that this test will be widely available in labs across the country, medical centers will be able to offer an objective blood test that can aid in concussion assessment," Beth McQuiston, medical director for Abbott's diagnostics business, said in a statement. A study from the University of California, San Francisco published last year found that the I-Stat test was able to predict patients who were most likely to die from their injuries or experience severe disability six months after the injury. Abbott's other blood-based TBI test, the I-Stat TBI Plasma test, received FDA clearance in 2021. It previously received clearance in the EU and has been available outside the US since 2021. The firm added that the test has nearly 97 percent sensitivity and 99 percent negative predictive value.

It can be used when a patient arrives at the hospital with a suspected mild TBI within 12 hours of the injury, Abbott noted. The assay measures two blood biomarkers - ubiquitin C-terminal hydrolase L1 and glial fibrillary acidic protein - that correlate to brain injury in elevated concentrations. The test runs on Abbott's Alinity I instrument and returns results in 18 minutes, with a negative result ruling out a CT scan, the firm said in a statement.

NEW YORK – Abbott announced on Tuesday that its laboratory-based test for traumatic brain injuries has received clearance from the US Food and Drug Administration.