Abbott announced it intends to close the acquisition of St. Jude Medical, Inc. The announcement follows receipt of all regulatory clearances necessary for closing. The transaction establishes Abbott as a leader in the medical device arena and provides expanded opportunities for future growt ... more
Abbott Receives FDA Emergency Use Authorization and Launches Test to Detect Novel Coronavirus
Company scaling up production at its U.S. manufacturing location
Abbott announced that the U.S. Food and Drug Administration has issued Emergency Use Authorization (EUA) for the company's molecular test for novel coronavirus (COVID-19). Abbott is immediately shipping 150,000 Abbott RealTime SARS-CoV-2 EUA tests to existing customers in the U.S. The tests are used on the company's m2000™ RealTime System. Abbott will be working with health systems and government authorities to deploy additional m2000 systems where they are needed.
"A global challenge like coronavirus requires the commitment and cooperation of everyone who has the ability to help address it," said Miles D. White, chairman and chief executive officer, Abbott. "I'm proud of the Abbott team and what they've accomplished in such a short period of time, and I want to thank the Administration and the FDA for their partnership in making this happen."
Accelerating testing to help combat the pandemic
Across the U.S., more than 175 m2000 systems are used in hospital and reference laboratories. The systems have the ability to run high volumes of up to 470 tests in 24 hours, helping to meet the increasing demand for testing. Many of these instruments are used in university and community hospitals where patients come for care, resulting in testing that happens closer to the patient rather than sending it to an offsite lab. Abbott is immediately distributing 150,000 tests and will continue ramping up production to the highest levels possible, with the goal of providing up to 1 million tests per week. Abbott is manufacturing these tests in the U.S.
- Emergency Use Authorization
Abbott announced it has received CE Marking (Conformité Européenne) in the European Union to market a new, highly sensitive diagnostic test for detection of hepatitis B surface antigen (HBsAg). The test is performed on Abbott's ARCHITECT® system. HBsAg assays may be used to help identify ac ... more
Abbott announced the availability of a new molecular test in the European Union and New Zealand designed to identify the presence of gene rearrangements associated with a specific form of non-small-cell lung cancer (NSCLC). These rearrangements in a gene known as ALK (anaplastic lymphoma k ... more
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