NEW YORK – Avacta said on Monday that it is pulling its AffiDX SARS-CoV-2 antigen lateral flow test from the market while it works to improve the assay's detection sensitivity.
The Wetherby, UK-based company achieved a CE-IVD mark for AffiDX last month, and on Dec. 15, announced that its test, which has a turnaround time of around 20 minutes and relies on nasal swab as a sample input, was capable of detecting the Omicron variant of the SARS-CoV-2 virus, following a small study with its partner, Carlos III Hospital in Madrid.
Further analysis, however, has shown that the sensitivity of AffiDX is reduced at lower viral loads.
As the company noted on Monday, the AffiDX SARS-CoV-2 test contains both an Affimer reagent and paired antibody. While its reagent detects the Omicron variant with the same sensitivity as it detected previous variants, such as Delta, the firm said the sensitivity of its antibody has been affected by the Omicron mutations. The company subsequently decided to pause sales of AffiDX while it replaces the antibody in its test.
"Our determination to only provide high quality, high performance diagnostic tests has led us to the correct decision to pause all marketing of the AffiDX lateral flow antigen test," said Alastair Smith, chief executive of the Avacta Group, in a statement.
Smith noted that the test is not yet available in Avacta's home market, the UK, as it is still awaiting approval under new Coronavirus Test Device Approvals, which entered into force in October. In December, Avacta announced an exclusive agreement with Medusa to commercialize AffiDX worldwide under the name MeduFlow.
Smith said that COVID-19 testing remains a "long-term commercial opportunity" for the company, and that it will use its experience to generate its next-generation antigen test.