US FDA issues EUA for molecular point-of-care test for detection of COVID-19 by Abbot

The test will run on company’s ID NOW platform, providing rapid results in a wide range of healthcare settings

Abbott recently announced that the US Food and Drug Administration (FDA) has issued Emergency Use Authorisation (EUA) for the fastest available molecular point-of-care test for the detection of novel coronavirus (COVID-19), delivering positive results in as little as five minutes and negative results in 13 minutes. The test will run on the company’s ID NOW platform, providing rapid results in a wide range of healthcare settings such as physicians’ offices, urgent care clinics and hospital emergency departments.

The ID NOW platform is small, lightweight (6.6 pounds) and portable (the size of a small toaster), and uses molecular technology.

“The COVID-19 pandemic will be fought on multiple fronts, and a portable molecular test that offers results in minutes adds to the broad range of diagnostic solutions needed to combat this virus,” said Robert B Ford, President and Chief Operating Officer, Abbott. “With rapid testing on ID NOW, healthcare providers can perform molecular point-of-care testing outside the traditional four walls of a hospital in outbreak hotspots.”

Abbott will be making ID NOW COVID-19 tests available next week to healthcare providers in urgent care settings in the US, where the majority of ID NOW instruments are in use. The company is working with the Administration to deploy tests to areas where they can have the greatest impact.