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FDA authorizes coronavirus test that can deliver results in as little as 5 minutes Staff





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 detective of novel coronavirus (COVID-19), delivering positive results in as little as five minutes and negative results in 13 minutes.

The test, developed by Abbott, will run on the company’s ID NOW platform, providing rapid results in a wide range of healthcare settings such as physician’s 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, which is valued by clinicians and the scientific community for its high degree of accuracy. ID NOW is the most widely available molecular point-of-care testing platform in the U.S. today.

Abbott will be making ID NOW COVID-19 tests available next week to healthcare providers in urgent care settings in the U.S., where the majority of ID NOW instruments are in use today.

The company is working with the FDA and U.S. Centers for Disease Control & Prevention (CDC) to deploy tests to areas where they can have the greatest impact.

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