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September 5, 2022

Nanomix and Mobility Health to develop test for Covid-19 antibodies

The companies will seek CLIA Lab Emergency Use Authorization for the test from the US FDA.

Nanomix will collaborate with Mobility Health to co-develop a Lab Development Test (LDT) that will evaluate the levels of Covid-19 circulating antibodies.

Under the partnership deal, Nanomix will supply the product elements and Mobility Health will complete development as well as validation of the new test, which is being developed for use in fully mobile labs.

Both companies will seek a CLIA Lab Emergency Use Authorization (EUA) for the test from the US Food and Drug Administration (FDA).

The new LDT will be developed using the Nanomix eLab system, which has been designed for quick point-of-care testing needs.

Nanomix eLab is a mobile, hand-held immunoassay and chemistry diagnostic system that provides results in minutes.

It uses patented multi-plex test cartridge technology that has been designed to bring diagnostics to the point of initial patient interaction.

Nanomix CEO Dr Thomas Schlumpberger said: “We share Mobility Health’s mission to transform community healthcare through increased accessibility to healthcare testing and services. 

“We believe our eLab system is the ideal mobile platform to provide rapid testing of Covid-19 antibodies, as well as many other future indications.”

Recently, the company launched the S1 Panel Cartridge to support the quick diagnosis of critical infections, including sepsis.

The panel detects three important biomarkers, namely lactate, procalcitonin (PCT) and C-reactive protein (CRP), from a single venous whole blood or plasma sample.

It runs on the Nanomix eLab Analyzer and provides results in around 12 minutes.

The S1 Panel assay has UK Medicines and Healthcare products Regulatory Agency (MHRA) registration as well as CE marking in Europe.

In May, Nanōmix’s Covid-19 rapid point-of-care (POC) antigen panel also received CE mark.

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