Medical technology firm Hologic’s molecular diagnostic test has received an emergency use authorisation approval from the US Food and Drug Administration (FDA) 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 enables the qualitative detection of RNA from the SARS-CoV-2 isolated and purified from nasopharyngeal (NP) and oropharyngeal (OP) swab specimens gathered from individuals who meet novel coronavirus clinical and/or epidemiological criteria.
Health care institutions such as hospitals, public health, and reference laboratories can conduct the test on Hologic’s Panther Fusion fully automated and molecular diagnostic platform.
Panther Fusion system can process nearly 1,150 coronavirus tests in 24 hours
The Panther Fusion system can deliver results within three hours and process nearly 1,150 coronavirus tests in 24 hours. It is claimed to be mostly used across the US.
The new assay on the Panther Fusion system employs Open Access reagents and functionality and must be carried out by the trained clinical laboratory staffs having the essential training in the operation of Panther Fusion system and in vitro diagnostic procedures.
The Panther molecular diagnostics system is a fully automated and sample-to-result platform that is being already extensively utilised in low, medium or high-throughput laboratories.
Hologic claims to have installed over 1,800 Panther systems in clinical diagnostic laboratories across the globe.
Beginning in April, the company expects to deliver approximately 600,000 SARS-CoV-2 tests a month, as it increases 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.”
