The new Aptima SARS-CoV-2 assay runs on the company’s Panther system, and detects the presence of novel coronavirus
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.
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.