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Tag Archives: Abbott

FDA approves therapy for myelodysplastic syndromes

December 2023—The FDA has approved ivosidenib (Tibsovo, Servier Pharmaceuticals) for the treatment of adult patients with relapsed or refractory myelodysplastic syndromes with an isocitrate dehydrogenase-1 mutation as detected by an FDA-approved test. The agency also approved the Abbott RealTime IDH1 assay as a companion diagnostic for the selection of R/R MDS patients with an IDH1 mutation.

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FDA clears Alinity h-series hematology system

October 2023—Abbott has received FDA clearance for its Alinity h-series hematology system, which includes the Alinity hq, an automated hematology analyzer, and Alinity hs, an integrated slide maker and stainer. The Alinity hq leverages multiangle polarized scatter separation (MAPPS) technology, which uses light scattering to distinguish cellular features and identify various blood cells, and processes up to 119 CBC results per hour. The system can be integrated into an existing core lab operation.

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FDA authorizes Abbott monkeypox test

December 2022—The FDA issued emergency use authorization to Abbott Molecular for the Alinity m MPXV, a real-time polymerase chain reaction test intended to detect monkeypox DNA using lesion swab specimens from individuals suspected of monkeypox virus infection. The test is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of PCR and in vitro diagnostic procedures. Testing is limited to CLIA-certified laboratories that meet the requirements to perform moderate- or high-complexity tests.

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FDA clears i-Stat CG4+, Chem8+

June 2020—Abbott’s i-Stat CG4+ and Chem8+ cartridges have received FDA clearance. The i-Stat CG4+ cartridge with the i-Stat 1 System is intended for use in the in vitro quantification of pH, PO2, PCO2, and lactate in arterial or venous whole blood in point-of-care or clinical laboratory settings. With the i-Stat CG4+, clinicians may assess the respiratory status of a patient or determine the presence of hyperlactatemia to inform the risk stratification of a patient diagnosed with sepsis.

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Abbott announces POC test for COVID-19

April 1, 2020—Abbott announced that the FDA has issued emergency use authorization for its molecular point-of-care test for the detection of novel coronavirus. The test delivers positive results in as few as five minutes and negative results in 13 minutes and runs on the company's ID Now platform.

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Abbott launches novel coronavirus test

March 19, 2020—Abbott has received emergency use authorization from the FDA for its molecular test for the identification of SARS-CoV-2. The Abbott RealTime SARS-CoV-2 EUA test can be used on Abbott’s m2000 RealTime system by authorized laboratories in the U.S.

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Newsbytes

September 2019—It’s a simple and nearly airtight communication strategy: Tell someone something verbally and then share the same message with them in writing to make sure they understood you. Following this logic, a group of surgical pathologists at the University of Minnesota Medical Center made an assumption that if their intraoperative consultation results were made available to surgeons in written form during surgery as documentation of verbal communication—either in person or via telephone—the frequency of communication errors would be reduced.

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RML selects Alinity

April 2019—Abbott announced that Regional Medical Laboratory, of Tulsa, Okla., will use Abbott’s Alinity ci-series. RML, part of the Ascension network, performs diagnostics testing for more than 2.4 million patients through hospital systems in Texas, Wisconsin, Oklahoma, Kansas, and Tennessee.

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Abbott gains CE mark for Alinity m system, assays

April 2019—Abbott announced it has received the CE mark for its Alinity m automated molecular diagnostics system and assays. Alinity m features ReadiFlex technology, the company’s proprietary technology for true random access, a universal sample rack, and a time to first result of less than 115 minutes. The system can provide 300 results in about eight hours and can have up to 20 assays onboard at one time.

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Abbott next-gen influenza A & B, strep A assays

Oct. 29, 2018—Abbott announced FDA clearance and CLIA waiver of its next-generation Influenza A & B 2 and Strep A 2 molecular assays for point-of-care testing. The Influenza A & B 2 assay detects and differentiates influenza A and B virus in 13 minutes or less, with early call out of positive results in as few as five minutes. The ...

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CE mark for handheld blood testing device , 2/17

February 2017—Abbott’s i-Stat Alinity System, a handheld blood testing platform, received CE marking and is for sale in Europe and other countries that recognize the CE mark. The portable device can perform and analyze a large menu of blood tests on a single device, ranging from blood chemistries to cardiac markers, using two to three drops of a person’s blood.

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Next-gen diagnostics systems, 10/16

October 2016—Abbott introduced Alinity, its harmonized family of next-generation systems across immunoassay, clinical chemistry, point-of-care, hematology, blood and plasma screening, and molecular diagnostics. Each Alinity platform will include a number of features to help institutions, clinicians, and laboratorians better navigate through the health care environment.

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Newsbytes, 8/15

August 2015—How one pathologist made use of artificial intelligence: Like many pathologists, Jay J. Ye, MD, PhD, longed to spend less time preparing reports and more time interpreting slides and rendering diagnoses. Rather than dedicating half of his workday to what he considers secretarial tasks, the dermatopathologist wanted to devote the lion’s share of his hours in the lab toward applying the knowledge and skills he developed during his years of medical training and practice.

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High-risk HPV test, 12/14

December 2014—Abbott’s DNA test for the detection of high-risk human papillomavirus is now available in Europe. The test identifies women at increased risk for development of cervical cancer or the presence of high-grade disease.

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Automated instrument analytics, 11/14

November 2014—Abbott has introduced an automated performance-monitoring subscription, mView, for its m2000 molecular diagnostics system. mView is a Web-based service designed to automate data ana-lysis and help laboratories reduce the number of manually generated reports.

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Additions and upgrades to Abbott’s m2000 system, 1/14

January 2014—Abbott received FDA approval to expand the use of its RealTime HCV and RealTime HBV assay to run on its m2000 RealTime System. The new mPlus makes it possible for laboratories of any size to perform molecular diagnostic tests for infectious disease detection and therapy monitoring. It also enhances the Abbott m2000’s flexibility and makes molecular testing easier and more efficient.

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HIV-1 test added to mPlus menu, 9/13

September 2013—Abbott has received FDA approval to expand the use of its RealTime HIV-1 assay to run on the company’s mPlus system. In April, Abbott introduced mPlus capability for its RealTime m2000 system to enhance the system’s flexibility and make molecular testing easier and more efficient for laboratories.

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Troponin assay, 9/13

AACC 2013 Abbott announced results from a study evaluating its high sensitive troponin-I (hsTnI) assay. The study, conducted by researchers at Brigham and Women’s Hospital, demonstrated that Abbott’s Architect stat hsTnI test may help doctors predict which patients presenting with symptoms of a heart attack are at a higher risk for having a heart attack 30 days after presentation. Researchers ...

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Flu A/B and RSV test, 10/13

Abbott will add a new FDA-cleared molecular diagnostic test for detection and differentiation of influenza A and B and respiratory syncytial virus to its infectious disease testing menu. The IMDx Flu A/B and RSV test developed by IntelligentMDx (IMDx) of Cambridge, Mass., is performed on Abbott’s m2000 molecular diagnostics system.

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CE Mark for HbA1c test

Abbott announced CE Marking for its Architect clinical chemistry hemoglobin A1c (HbA1c) test, which may aid physicians in diagnosing and monitoring diabetes as well as identifying patients at risk for developing diabetes.

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Influenza A/B and RSV molecular test

Abbott has introduced in the European Union and other areas outside of the United States a molecular diagnostic test for the detection of influenza A/B and RSV (respiratory syncytial virus). The IMDx flu A/B and RSV assay, developed by Intelligent Medical Devices for Abbott’s m2000 molecular diagnostics analyzer, is performed on nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. It is a qualitative, reverse-transcription polymerase chain reaction test for rapid detection of influenza A/B and RSV.

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Abbott to adopt cell imaging software for ALK FISH probe test

Abbott and BioView have entered into an agreement in which BioView will develop automated digital-imaging software for use with Abbott’s molecular diagnostic test to detect rearrangements of the ALK gene in patients with advanced non-small cell lung cancer. The software scans lung tissue specimens that have been tested for the ALK gene rearrangement with Abbott’s fluorescence in situ hybridization technology.

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