APBN New Site

APBN Developing Site

Multiplex COVID-19 Test Kit Launches to Include Testing for Influenza A and B

Singapore’s Agency for Science, Technology and Research (A*STAR, Tan Tock Seng Hospital (TTSH) and Singapore-based molecular diagnostic company MiRXES expand range of infectious disease testing solutions with the Fortitude Syndromic Panel Kit.

During the winter months, the COVID-19 pandemic coincides with the flu season. Patients with COVID-19 or flu exhibit a set of similar symptoms (flu-like syndrome), making it difficult for healthcare professionals to differentiate them based on symptoms alone. 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, will launch 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) and the CE mark approval for the deployment of the Fortitude Syndromic Panel Kit, and is currently applying for 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 Syndromic Panel Kit 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-CoV-2 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 Syndromic Panel Kit 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. To date, the Fortitude Kit has been deployed in 13 Singapore hospitals and labs and exported to more than 40 countries worldwide, including the United States, Hong Kong, and Panama.

“Following the deployment of the MiRXES Fortitude Kit worldwide, we continue to monitor and identify global needs in infectious disease testing. We are working in close collaboration with key partners such as A*STAR and TTSH to meet these needs by expanding our Fortitude COVID-19 test range. Hospitals and labs in US, Europe, and Japan have already expressed interest in deploying the Fortitude Syndromic Panel Kit,” said Dr Zhou Lihan, Co-founder and Chief Executive Officer of MiRXES.

“Singapore’s Health Sciences Authority’s leadership in regulatory science has been instrumental in supporting innovations from our start-ups and SMEs, enabling them to obtain regulatory approvals in other jurisdictions, such as the European CE and US FDA. The new multiplex Fortitude Syndromic Panel Kit will continue to put Singapore on the map with our innovations in diagnostics,” said Dr Sidney Yee, Chief Executive Officer of the DxD Hub, A*STAR.

“TTSH with collaborators at A*STAR, has been providing novel diagnostic solutions for our patients since the threat of SARS and ‘Bird flu’ in 2003. Our assay for respiratory organisms is a panel designed to simultaneously detect an array of Influenza viruses, with slots specifically reserved to rapidly incorporate a test for any emerging virus with epidemic or pandemic potential, as previously done for Bird flu, Swine flu, and MERS-CoV. The assimilation of SARS-CoV-2 into our influenza panel was a natural progression, planned for since inception. The expanded panel was ready for TTSH deployment as early as March 2020, a testament to the long-term commitment of a small group of medical, science, and technical collaborators,” said Adj A/Prof Timothy Barkham, Senior Consultant, Department of Laboratory Medicine, TTSH. [APBN]