Clinical validation in the works for COVID-19 diagnostic test

CAMBRIDGE & WETHERBY, U.K.—On July 22, Avacta Group plc, the developer of Affimer biotherapeutics and reagents, announced that it has begun work with the U.K. government’s CONDOR program to evaluate and clinically validate the high-throughput COVID-19 bead-assisted mass spectrometry (BAMS) laboratory assay developed with Adeptrix of Beverly, Mass, in the United States.

The COVID-19 National Diagnostic Research and Evaluation Platform (or CONDOR)—recently funded by the National Institute for Health Research, UK Research and Innovation, Asthma UK and the British Lung Foundation—was created by the UK government to provide a route for evaluating new COVID-19 diagnostic tests in hospitals and in community healthcare settings.

Adeptrix’s novel and proprietary BAMS platform uses Affimer reagents to capture the virus and viral proteins from patient samples and combines this with the power of mass-spectrometry analysis to provide a highly sensitive and specific diagnostic test. Up to 1,000 nasopharyngeal swab or saliva samples per day can be analyzed by a single technician using the BAMS assay, making it a very attractive high-throughput technique for COVID-19 screening in the clinical setting.

Through the collaboration with the CONDOR scheme, Avacta will be provided access to patient samples and collaborators in U.K. hospitals to evaluate the performance of the prototype BAMS assay and to conduct the clinical validation study.

“We are confident that the BAMS assay will perform very well and potentially provide a new gold standard for laboratory reference testing for the COVID-19 infection,” said Dr. Alastair Smith, chief executive of Avacta Group. “The BAMS assay runs on equipment that is already installed in most hospital clinical microbiology labs but is currently unused for COVID-19 testing.”