Abbott has announced that the FDA has issued Emergency Use Authorisation (EUA) for the its molecular test for COVID-19. According to a press release, Abbott is immediately shipping 150,000 Abbott RealTime SARS-CoV-2 EUA tests to existing customers in the USA. The tests are used on the company’s m2000 RealTime System. The company will be working with health systems and government authorities to deploy additional m2000 systems where they are needed.
The press release reports that Abbott is working to “do its part” to combat the global pandemic. Across the USA, 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.
Miles D White, chairman and CEO at Abbott, comments: “A global challenge like coronavirus requires the commitment and cooperation of everyone who has the ability to help address it. I am proud of the Abbott team and what they have 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.”