The US FDA has initially granted the EUA for the molecular diagnostic test in May 2020, to detect the Covid-19 infection in symptomatic individuals
Hologic has received the expanded US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for its Aptima SARS-CoV-2 assay, to include testing of asymptomatic individuals, or others suspected of Covid-19 infection.
The US regulatory agency has initially granted the EUA for the molecular diagnostic test in May 2020, to test the individuals with symptoms of Covid-19 infection.
The authorisation follows the guidance recently issued by US Centres for Disease Control and Prevention (CDC), recommending Covid-19 tests for people who contacted the infected individuals, to contain the spread of the virus, said the company.
Hologic diagnostic solutions division president Kevin Thornal said: “For many years, molecular tests – tests that directly detect the genetic material of pathogens – have been recognized as the gold standard for infectious disease diagnostics.
“They remain the most sensitive and accurate available options, which is particularly important when screening individuals with no symptoms or known contact with infected people, and therefore no clues about their infectious state.”
Aptima SARS-CoV-2 assay runs on Hologic’s automated Panther system
Hologic said that the proposal for asymptomatic screening is supported by existing analytical data, including results published in FDA report, along with the results from its on-going clinical study.
Also, the FDA report demonstrated that Hologic’s assays feature superior analytically sensitive of the fully automated, high-throughput molecular tests available in the market.
Aptima SARS-CoV-2 assay is designed to work on the company’s completely automated Panther system. The system is capable of providing initial results in around three hours and process more than 1,000 tests within 24 hours.
Along with the assay and the testing device, the FDA has authorised the company’s pooling protocol for symptomatic testing using the Aptima SARS-CoV-2 assay.
Hologic has validated the Aptima and Panther Fusion assays for diagnosis of Covid-19 using pooling of patient samples, which facilitates the simultaneous testing of samples drawn from various individuals.
Recently, the company has secured the EUA for its Panther Fusion SARS-CoV-2 assay to detect asymptomatic Covid-19 individuals.