By allowing samples from multiple individuals to be tested simultaneously, pooling helps laboratories deliver increasing numbers of test results more quickly.
By allowing samples from multiple individuals to be tested simultaneously, pooling helps laboratories deliver increasing numbers of test results more quickly.
Hologic’s assay was the first widely available, high-throughput molecular diagnostic test specifically authorized for screening asymptomatic people.
Hologic’s assay was the first widely available, high-throughput molecular diagnostic test specifically authorized for screening asymptomatic people.
Hologic announces a $119 million contract from the United States government to expand production capacity for COVID-19 molecular tests.
Hologic announces a $119 million contract from the United States government to expand production capacity for COVID-19 molecular tests.
The Aptima SARS-CoV-2, Panther Fusion SARS-CoV-2, and Aptima SARS-CoV-2/Flu assays are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
**Based on local regulatory authorization and inventory availability in the customer’s geography. Contact your local Hologic representative for more information about product availability.
*The Aptima®SARS-CoV-2 assay and Aptima SARS-CoV-2/Flu and Panther Fusion SARS-CoV-2 assays have not been FDA cleared or approved: These tests have been authorized by FDA under an EUA for use by authorized laboratories; The Aptima and Panther Fusion SARS-CoV-2 assays have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; The Aptima SARS-CoV-2/Flu assay has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acid from SARS-CoV-2, influenza A virus, influenza B virus, and not for any other viruses or pathogens.