US-based medical technology company Hologic has received the US Food and Drug Administration (FDA) Emergency Use Authorisation (EUA) for its Aptima SARS-CoV-2 assay.
The new Aptima SARS-CoV-2 assay runs on the company’s Panther system, and detects the presence of novel coronavirus, which causes Covid-19.
Hologic said that its Panther system is capable of providing initial results in approximately three hours and process more than 1,000 coronavirus tests in 24 hours.
The system is a fully automated, high-throughput molecular diagnostic platform with a small footprint, adaptable workflow options and consolidated testing menu.
Hologic chairman, president and CEO Steve MacMillan said: “Delivering test results when and where they are needed – so people can either get back to work or quarantine themselves – is key to re-opening global economies safely. I’m so proud of the incredible teamwork across the company that brought this test to market so quickly.”
BARDA has supported the Aptima SARS-CoV-2 assay project under a $13m contract
The Biomedical Advanced Research and Development Authority (BARDA), a part of the US Department of Health and Human Services, has aided certain aspects of the Aptima SARS-CoV-2 assay project, under a $13m contract.
The company intends to seek a CE Mark approval for diagnostic use of its Aptima SARS-CoV-2 assay in Europe. It has already started distributing its new coronavirus test, and is planning to produce an average of one million tests per week.
In March, Hologic secured EUA for its new Panther Fusion SARS-CoV-2 assay.
The Panther Fusion SARS-CoV-2 assay is a real-time RT-PCR in vitro diagnostic test, which facilitates the qualitative detection of RNA from the SARS-CoV-2 isolated and purified from nasopharyngeal (NP) and oropharyngeal (OP) swab specimens collected from individuals who meet COVID-19 clinical and/or epidemiological criteria.
