The Metrix Covid-19 Test is designed for the qualitative detection of nucleic acid from the SARS-CoV-2 virus. Credit: SEKISUI Diagnostics.

SEKISUI Diagnostics has signed an exclusive distribution agreement with decentralised molecular diagnostics developer Aptitude Medical Systems to sell the Metrix Covid-19 test in the US market.

Said to be the only Emergency Use Authorization (EUA)-approved molecular test, Matrix can be used with both anterior swab and saliva samples. It can be administered by healthcare professionals or at home.

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The single-use molecular in vitro diagnostic test is designed for the qualitative detection of nucleic acid from the SARS-CoV-2 virus.

This partnership aims to expand the accessibility of Covid-19 testing in both point-of-care settings and for home use.

SEKISUI Diagnostics strategy and business management senior vice-president Lee Lipski said: “The unique features of this test are what make this addition to our portfolio so exciting.  It pairs a molecular test with a small, low-cost reader which provides highly accurate results in an affordable and simple-to-use format, which can fit in the palm of your hand. 

“This aligns with efforts to expand into the molecular testing market and the company’s long-term strategic vision.”

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The distribution agreement also grants SEKISUI Diagnostics access to a second assay within Aptitude’s product pipeline, currently under clinical trials.

SEKISUI Diagnostics president and CEO Bob Schruender said: “Our investment and partnership with Aptitude will drive manufacturing, scale-up and portfolio expansion which supports our mission to provide intelligent solutions to the healthcare market and more specifically, to bring molecular testing into the home.”

In April 2023, Aptitude received up to $53.7m grant from the Biomedical Advanced Research and Development Authority (BARDA) to support the development of over-the-counter molecular diagnostic tests.