US-based Cue Health has announced plans to develop an Omicron-Genotyping Covid-19 test for use in professional point-of-care settings.
The move is part of the company’s ongoing partnership with the US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA).
The Omicron-specific test will complement its existing molecular Covid-19 test, which can detect all Covid-19 variants, including Omicron, said the company.
Cue Health aims to use the additional funding support from BARDA to advance the development, validation, and regulatory authorisation of a single-plex assay.
The test will be designed to detect the Omicron variant using nasal samples, and will be compatible with its monitoring system and mobile application.
It leverages molecular nucleic acid amplification technology (NAAT), which delivers accurate self-test for Covid-19, with lab-quality results.
Cue co-founder and CEO Ayub Khattak said: “An Omicron-specific test will assist clinicians in providing patients better treatment options and containment strategies at the time of a positive diagnosis.
“We are proud to partner with BARDA to develop this new test, which will help eliminate guesswork, provide more choices for patients, and strengthen public health outcomes for communities.”
Cue has initially received $30m funding from BARDA in 2018, for the development and regulatory validation of Influenza and Multiplex Respiratory Pathogen diagnostic cartridges for its monitoring system.
In March 2020, the company was awarded $13m BARDA funding for the development, validation, and FDA approval of a portable, molecular diagnostic test to detect SARS-CoV-2.
Its professional point-of-care Covid-19 test received the US FDA Emergency Use Authorization (EUA) in June 2020.
In March last year, FDA approved Cue molecular test for at-home and over-the-counter use without a prescription.
Cue noted that its tests work by targeting a region of the nucleocapsid gene and the accuracy of its test remains unaffected by the mutations in the Omicron variant and other variants.
The company has received the CE mark in the EU, Interim Order authorisation from Health Canada, Central Drugs Standard Control Organization (CDSCO) approval in India, and PSAR authorisation from Singapore’s Health Sciences Authority for its diagnostic test.
