Coronavirus company news summary - FDA discontinues EUA review of SQI Diagnostics’ triage test - Abingdon Health agrees to produce BioSure's lateral flow tests - Verdict Medical Devices
Join Our Newsletter - Get important industry news and analysis sent to your inbox – sign up to our e-Newsletter here
X

Coronavirus company news summary – FDA discontinues EUA review of SQI Diagnostics’ triage test – Abingdon Health agrees to produce BioSure’s lateral flow tests

26 Jul 2021

The US Food and Drug Administration (FDA) has stopped its Emergency Use Authorization (EUA) review of SQI Diagnostics’ RALI-Dx IL-6 Severity Triage Test due to a high volume of EUA requests and its prioritisation of reviews. The regulator asked SQI to seek a non-EUA regulatory clearance for the test, which is designed to detect patients having severe inflammatory responses caused by Covid-19 or any other source of respiratory distress.

Abingdon Health has entered an exclusive agreement to produce BioSure‘s lateral flow tests (LFTs) for Covid-19. The terms of the deal involve Abingdon’s York and Doncaster plants’ lateral flow manufacturing facilities. These tests will be supplied to the UK and global markets. Financial details of the agreement were not disclosed.

BD has secured EUA from the FDA for its Vacutainer Plus Citrate Plasma Tubes (UK manufacturing site). This tube is indicated for use in emergency settings to obtain, transport and store blood samples for coagulation testing. The device is expected to facilitate the detection and treatment of coagulopathy in patients with known or suspected Covid-19 among other conditions.