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Sekisui Diagnostics, Aptitude Medical Systems Sign US Distribution Deal for POC COVID Test

NEW YORK — Sekisui Diagnostics said Wednesday that it has signed an exclusive US distribution agreement for Aptitude Medical Systems' point-of-care Aptitude Metrix COVID-19 Test.

Sekisui Diagnostics said that the deal also covers a second undisclosed assay that Goleta, California-based Aptitude is currently evaluating in clinical trials. Additional terms were not disclosed.

The Aptitude Metrix assay is a single-use test that received Emergency Use Authorization from the US Food and Drug Administration in late 2022 for the detection of SARS-CoV-2 virus in self-collected saliva or anterior nasal swab samples. It uses real-time loop-mediated isothermal amplification paired with an electrochemical reporting technology that monitors the amplified cDNA in real time. The electrochemical signal is analyzed automatically with a paired reader, providing a result in 30 minutes or less.

The assay "pairs a molecular test with a small, low-cost reader [that] provides highly accurate results in an affordable and simple-to-use format [that] can fit in the palm of your hand," Lee Lipski, senior VP of strategy and business management at Sekisui Diagnostics, said in a statement. "This aligns with efforts to expand into the molecular testing market and the company's long-term strategic vision."

Sekisui Diagnostics, based in Burlington, Massachusetts, is a subsidiary of Japan's Sekisui Chemical. In mid-2023, it launched an at-home COVID-19 antigen test in the US.