Healthcare firm Abbott has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its molecular test to detect COVID-19, a novel coronavirus.
The company is instantly supplying 150,000 RealTime SARS-CoV-2 EUA tests to existing customers in the US. The tests will be conducted on Abbott’s m2000 RealTime system.
Abbott will also work with the health systems and government authorities to supply additional m2000 systems as per the requirement. The company aims to supply up to one million tests per week.
According to the company, over 175 m2000 systems are being used in hospital and reference laboratoriesa across the US.
The 175 m2000 systems can run high volumes of up to 470 tests in 24 hours
The 175 m2000 systems hold capacity to run high volumes of up to 470 tests in 24 hours, enabling to better meet the increasing demand for testing.
The m2000 RealTime system is a molecular solution, which offers a broad menu of tests for infectious diseases.
The system applies polymerase chain reaction (PCR) technology that amplifies a single piece of DNA to rapidly and precisely diagnose a patient. It is presently used in labs across the world.
Abbott chairman and CEO Miles White said: “A global challenge like coronavirus requires the commitment and cooperation of everyone who has the ability to help address it.
“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.”
In January, Abbott secured FDA approval for its new Infinity Deep Brain Stimulation (DBS) system, with expanded indication to include targeting of internal globus pallidus (GPi).
DBS system has been developed to offer directed stimulation to the areas of the brain for optimising patient outcomes and limit side effects.
