Hologic gets FDA s EUA status for Panther Fusion SARS CoV 2 assay
Medical technology company Hologic has secured emergency use authorisation (EUA) for its new Panther Fusion SARS-CoV-2 assay.
The company has developed the new molecular diagnostic test for the detection of SARS-CoV-2 virus, which is responsible for COVID-19 disease.
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.
Hospital, public health, and reference laboratories can conduct the test on Hologic’s Panther Fusion fully automated and molecular diagnostic platform, which is mostly used across the US.
The Panther Fusion system, which can generate results within three hours, can process around 1,150 coronavirus tests in a 24-hour period.
The new assay on the Panther Fusion system applies Open Access reagents and functionality and must be performed by the trained clinical laboratory personnel with Panther Fusion system and in vitro diagnostic procedures.
The Panther molecular diagnostics system is a fully automated and sample-to-result platform designed to be used in low, medium or high-throughput laboratories.
According to the company, over 1,800 Panther systems were installed in clinical diagnostic laboratories across the world.
From April, Hologic expects to produce nearly 600,000 SARS-CoV-2 tests a month, as it ramps up production capacity.
Hologic chairman, president and CEO Steve MacMillan said: “As one of the largest molecular diagnostic companies in the world, Hologic can make a huge difference in the coronavirus pandemic with our scientific expertise and fully automated, high-throughput testing system.
“As soon as the outbreak started, our diverse team of scientists and engineers began developing a new, highly accurate test, and we have brought it to market quickly through the FDA’s emergency use process and with assistance from BARDA.”
In January 2019, Hologic secured FDA approval for its Aptima Mycoplasma genitalium assay, which helps to detect the under-recognised and common sexually transmitted infection (STI).