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Posted: November 17, 2020
  • Product News

Abingdon Health completes FDA Section IV.D notification process

This enables the AbC-19™ Rapid Test to be distributed in the United States

Abingdon Health (“Abingdon” or “the Company”), UK-based developer and manufacturer of lateral flow rapid tests and smartphone reader solutions, today announces that it 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 AbC-19™ 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-19TM 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 AbC-19™ 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 AbC-19™ Rapid Test. Abingdon Health and our consortium partners in the UK-RTC remain committed to the wide deployment of the AbC-19™ Rapid Test and continue to work with regulators both in the UK and internationally.”

For more information please contact:

Abingdon Health
Tel: +44 (0) 1904 406082
Email: [email protected]
Chris Yates, CEO

Consilium Strategic Communications
Tel: +44 (0) 203 709 5700
Email: [email protected]
Mary-Jane Elliott
Matthew Neal

About Abingdon Health

Abingdon Health is a UK-based developer and manufacturer of lateral flow tests and smartphone reader solutions. Abingdon Health offers development and manufacturing services for customers looking to develop new assays or looking to transfer existing laboratory-based assays to a lateral flow format. Abingdon Health takes projects from initial concept through to routine and large-scale manufacturing. Abingdon is headquartered in York, England.

About UK-RTC

The UK-RTC was established by Abingdon Health, Omega Diagnostics, BBI Solutions, CIGA Healthcare and Oxford University.

About AbC19™ Rapid Test

The AbC-19TM IgG lateral flow assay is targeted at IgG antibodies to the full spike protein of SARS-CoV-2 (COVID19) to indicate a measure of immune response (aligned with neutralizing antibodies).