Abbott Launches Molecular POC Test to Detect Novel Coronavirus in as Little as 5 Minutes
Abbott has announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (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 testwill run on the company's ID NOW™ platform, providing rapid results in a wide range ofhealthcare settings such as physicians' offices, urgent care clinics and hospital emergencydepartments.The ID NOW platform is small, lightweight (6.6 pounds) and portable (the size of a small toaster), and uses molecular technology, which is valued by clinicians and the scientific community for itshigh degree of accuracy. ID NOW is already the most widely available molecular point-of-caretesting platform in the U.S. today.
"The COVID-19 pandemic will be fought on multiple fronts, and a portable molecular test thatoffers results in minutes adds to the broad range of diagnostic solutions needed to combat thisvirus," 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 traditionalfour walls of a hospital in outbreak hotspots."Abbott will be making ID NOW COVID-19 tests available next week to healthcare providers inurgent care settings in the U.S., where the majority of ID NOW instruments are in use today. The company is working with the Administration to deploy tests to areas where they can have thegreatest impact.
The arrival of the Abbott ID NOW COVID-19 test comes a week after the company launched itsAbbott m2000™ RealTime SARS-CoV-2 EUA test, which runs on the m2000™ RealTime Systemlocated in hospital and reference labs around the world. Between the two platforms, Abbott expectsto produce about 5 million tests per month.About the ID NOW™ Molecular PlatformAs the world leader in point-of-care diagnostics, Abbott is adding its expertise and scale to helpfight the COVID-19 global pandemic.
First introduced in 2014, ID NOW is the leading molecularpoint-of-care platform for Influenza A & B, Strep A and RSV testing in the U.S. ID NOW is a rapid, instrument-based, isothermal system for the qualitative detection of infectiousdiseases. Its unique isothermal nucleic acid amplification technology provides molecular results injust minutes, allowing clinicians to make evidence-based clinical decisions during a patient visit.