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Singapore launches multiplex test kit for SARS-CoV-2 and Influenza A & B

20 January 2021 | News

MiRXES has obtained Provisional Authorisation from Singapore’s Health Sciences Authority (HSA) for the deployment of the Fortitude Syndromic Panel Kit

To assist in accurate diagnoses, the Agency for Science, Technology and Research (A*STAR), Tan Tock Seng Hospital (TTSH), and MiRXES, a leading molecular diagnostic company headquartered in Singapore, are launching a multiplex COVID-19 kit that simultaneously tests for SARS-CoV-2 and influenza. This will make a decisive difference as accurate and timely diagnosis is critical during the ongoing third wave of the COVID-19 outbreak in the Northern Hemisphere.

MiRXES has obtained Provisional Authorisation from Singapore’s Health Sciences Authority (HSA) for the deployment of the Fortitude SARS-CoV-2 & Flu A/B Test, and is currently applying for CE Mark, Emergency Use Authorisation (EUA) from the United States Food and Drug Administration (FDA), and approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

The Fortitude SARS-CoV-2 & Flu A/B Test combines the tested and proven RT-PCR Fortitude Kit with syndromic panel assays for Influenza A, and Influenza B. This multiplex diagnostic detects and differentiates SARS-CoV2 viruses that cause COVID-19, and other pathogens that cause seasonal epidemics of influenza (flu). This will help healthcare professionals detect and differentiate patients with these infections, and offer more precise treatment options.

The Fortitude SARS-CoV-2 & Flu A/B Test is built on the original Fortitude Kit developed in Singapore by A*STAR and TTSH, which was licensed to MiRXES for mass production and distribution in February 2020.

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