Abingdon Health completes FDA's Section IVD process for rapid COVID-19 test

Abingdon Health, a UK-based developer and manufacturer of lateral flow tests and smartphone reader solutions, has been notified by the US Food and Drug Administration (FDA) that it has completed the Section IV.D notification process.

This enables the company to distribute its UK-RTC AbC19 Rapid Test in the USA to laboratories certified under CLIA and to healthcare workers, for point of care testing covered by a laboratory’s CLIA certification for high complexity testing. Distribution of the test will be through CIGA Healthcare, a member of the UK-RTC.

Section IV.D of the FDA’s Policy for Coronavirus Disease Tests During the Public Health Emergency (Revised) states that the FDA does not intend to object to a manufacturer distributing serology tests to laboratories that are certified under CLIA certification to perform high complexity testing where the test has been validated and while the manufacturer is preparing its Emergency Use Authorization (“EUA”) request. An EUA has been submitted to the FDA for the AbC-19 Rapid Test as a point of care test and dialogue with the FDA is progressing. 

Leigh Thomas, SVP director of global sales of Abingdon Health said: “Today’s news allows us to immediately make the AbC19 Rapid Test available to CLIA testing labs in the United States and is the latest milestone on the path to receiving an EUA for the AbC19 Rapid Test. Abingdon Health and our consortium partners in the UK-RTC remain committed to the wide deployment of the AbC19 Rapid Test and continue to work with regulators both in the UK and internationally.”