Hologic has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Panther Fusion SARS-CoV-2 assay to detect asymptomatic Covid-19 individuals.
The EUA status enables to use of Panther Fusion SARS-CoV-2 assay to screen individuals without symptoms or other reasons to suspect Covid-19 infection.
The FDA has authorised the asymptomatic screening claim based on available analytical data and the company’s commitment to submit results from an ongoing clinical evaluation that is underway with various laboratory partners.
Hologic also secured FDA authorisation for its pooling protocol for symptomatic testing with the Panther Fusion SARS-CoV-2 assay.
The company’s pooling protocol facilitates clinical laboratories to integrate up to five patient samples into a single tube for processing.
A negative result is said to confirm that all five individuals have tested negative for SARS-CoV-2. All five samples will be re-tested individually to confirm which patient or patients are infected in cases of a positive result.
Hologic’s Panther Fusion system is used to run the asymptomatic test
Hologic’s fully automated Panther Fusion system is used to run the Panther Fusion SARS-CoV-2 test. It has the capacity to deliver initial results in around three hours and process over 1,000 coronavirus tests in one day.
Hologic diagnostic solutions division president Kevin Thornal said: “Accurately identifying individuals early in the course of infection – so they can quarantine before passing on the virus – is critical to stemming the spread of this pandemic.
“The high accuracy of molecular testing has made it the gold standard for infectious disease detection, and recent data demonstrate that Hologic’s molecular coronavirus tests are among the most sensitive available.”
In addition, the company is pursuing an EUA status for Aptima SARS-CoV-2 assay to screen asymptomatic individuals with Covid-19.
In May this year, Hologic secured FDA EUA status for its Aptima SARS-CoV-2 assay, which detects the presence of novel coronavirus.
