Hologic's Role in the Fight Against COVID

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January 10, 2020

Genomic sequence of SARS-CoV-2 assay is published in scientific journal.

January 10, 2020

Genomic sequence of SARS-CoV-2 assay is published in scientific journal.

March 16, 2020

Hologic announces Emergency Use Authorization from the U.S. FDA for its first COVID-19 test, the Panther Fusion® SARS-CoV-2 Assay.*

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March 16, 2020

Hologic announces Emergency Use Authorization from the U.S. FDA for its first COVID-19 test, the Panther Fusion® SARS-CoV-2 Assay.*

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May 15, 2020

Hologic receives Emergency Use Authorization for its second COVID-19 test, the Aptima® SARS-CoV-2 Assay,* which can be produced in large quantities.

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May 15, 2020

Hologic receives Emergency Use Authorization for its second COVID-19 test, the Aptima® SARS-CoV-2 Assay,* which can be produced in large quantities.

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August 11, 2020

Hologic launches a validated pooling protocol for clinical laboratory customers.

By allowing samples from multiple individuals to be tested simultaneously, pooling helps laboratories deliver increasing numbers of test results more quickly.

August 11, 2020

Hologic launches a validated pooling protocol for clinical laboratory customers.

By allowing samples from multiple individuals to be tested simultaneously, pooling helps laboratories deliver increasing numbers of test results more quickly.

September 28, 2020

Hologic granted FDA Emergency Use Authorization for asymptomatic COVID-19 testing with Panther Fusion SARS-CoV-2 Assay.

Hologic’s assay was the first widely available, high-throughput molecular diagnostic test specifically authorized for screening asymptomatic people.

September 28, 2020

Hologic granted FDA Emergency Use Authorization for asymptomatic COVID-19 testing with Panther Fusion SARS-CoV-2 Assay.

Hologic’s assay was the first widely available, high-throughput molecular diagnostic test specifically authorized for screening asymptomatic people.

October 6, 2020

FDA amends Emergency Use Authorization for Hologic’s Aptima SARS-CoV-2 Assay to include COVID-19 testing of asymptomatic individuals.

October 6, 2020

FDA amends Emergency Use Authorization for Hologic’s Aptima SARS-CoV-2 Assay to include COVID-19 testing of asymptomatic individuals.

October 30, 2020

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.

October 30, 2020

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.

December 31, 2020

Hologic completes shipment of approximately 68 million tests to 40 countries in 2020.

December 31, 2020

Hologic completes shipment of approximately 68 million tests to 40 countries in 2020.

July 14, 2021

Hologic announces CE-mark for the Aptima® SARS-CoV-2 assay for use with saliva samples.

July 14, 2021

Hologic announces CE-mark for the Aptima® SARS-CoV-2 assay for use with saliva samples.

October 27, 2021

Hologic launches the Aptima® SARS-CoV-2/Flu assay for simultaneous detection of COVID, influenza A and influenza B.

October 27, 2021

Hologic launches the Aptima® SARS-CoV-2/Flu assay for simultaneous detection of COVID, influenza A and influenza B.

November 29, 2021

Hologic announces that all three of its COVID-19 tests detect the Omicron variant

November 29, 2021

Hologic announces that all three of its COVID-19 tests detect the Omicron variant

DISCLAIMER, CONTINUED

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.

DISCLAIMER, CONTINUED

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.

DISCLAIMER

*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.

DISCLAIMER

*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.

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