Coronavirus company news summary – Thermo Fisher introduces two Covid-19 antibody tests – FDA issues EUA for Abbott’s serology test

13 October 2020 (Last Updated October 13th, 2020 10:48)

Applied DNA Sciences subsidiary Applied DNA Clinical Laboratories has won contract for Covid-19 surveillance testing under its testing-as-a-service offering. This offering is expected to generate a total annualised revenue of over $1m.

Thermo Fisher Scientific has announced the launch of two new SARS-CoV-2 antibody tests, the Thermo Scientific OmniPATH Covid-19 Total Antibody ELISA test and the Thermo Scientific EliA SARS-CoV-2-Sp1 IgG test. OmniPATH Covid-19 Total Antibody ELISA test has received the Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA). The EUA for the EliA SARS-CoV-2-Sp1 IgG test is under review by the FDA. Currently, the test is available under the FDA's Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised).

BioGX has received EUA from the FDA for an extraction-free, direct sample addition RT-PCR test to detect SARS-CoV-2 viral RNA in patients. The Xfree Covid-19 Direct RT-PCR test is a complete test in a single vial, lyophilized in BioGX Sample-Ready format.

Abbott has received EUA from the FDA for its AdviseDx SARS-CoV-2 IgM lab-based serology test. The test is designed to be used on the ARCHITECT and Alinity platforms. Abbott has received EUA for seven Covid-19 tests since the start of the pandemic.