Hologic's Role in the Fight Against COVID
Genomic sequence of SARS-CoV-2 assay is published in scientific journal.
Genomic sequence of SARS-CoV-2 assay is published in scientific journal.
Hologic announces Emergency Use Authorization from the U.S. FDA for its first COVID-19 test, the Panther Fusion® SARS-CoV-2 Assay.*
Hologic announces Emergency Use Authorization from the U.S. FDA for its first COVID-19 test, the Panther Fusion® SARS-CoV-2 Assay.*
Hologic receives Emergency Use Authorization for its second COVID-19 test, the Aptima® SARS-CoV-2 Assay,* which can be produced in large quantities.
Hologic receives Emergency Use Authorization for its second COVID-19 test, the Aptima® SARS-CoV-2 Assay,* which can be produced in large quantities.
Hologic launches a validated pooling protocol for clinical laboratory customers.
Hologic launches a validated pooling protocol for clinical laboratory customers.
Hologic granted FDA Emergency Use Authorization for asymptomatic COVID-19 testing with Panther Fusion SARS-CoV-2 Assay.
Hologic granted FDA Emergency Use Authorization for asymptomatic COVID-19 testing with Panther Fusion SARS-CoV-2 Assay.
FDA amends Emergency Use Authorization for Hologic’s Aptima SARS-CoV-2 Assay to include COVID-19 testing of asymptomatic individuals.
FDA amends Emergency Use Authorization for Hologic’s Aptima SARS-CoV-2 Assay to include COVID-19 testing of asymptomatic individuals.
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.
Hologic completes shipment of approximately 68 million tests to 40 countries in 2020.
Hologic completes shipment of approximately 68 million tests to 40 countries in 2020.
Hologic announces CE-mark for the Aptima® SARS-CoV-2 assay for use with saliva samples.
Hologic announces CE-mark for the Aptima® SARS-CoV-2 assay for use with saliva samples.
Hologic launches the Aptima® SARS-CoV-2/Flu assay for simultaneous detection of COVID, influenza A and influenza B.
Hologic launches the Aptima® SARS-CoV-2/Flu assay for simultaneous detection of COVID, influenza A and influenza B.
Hologic announces that all three of its COVID-19 tests detect the Omicron variant
Hologic announces that all three of its COVID-19 tests detect the Omicron variant
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.
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.