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Hologic SARS-CoV-2 Assays

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    Overview

    Global Threat with Flexible Solutions

    The emergence of SARS-CoV-2 was unforeseen, and the worldwide outbreak of COVID-19 has already impacted millions.

    Since then, the need and recommendations for testing for SARS-CoV-2 have continuously evolved, requiring labs to be flexible with their strategies over time. Hologic’s SARS-CoV-2 portfolio and scalable automation enable labs to react to these changing needs and fully automate COVID-19 testing. With Panther® Scalable Solutions, you can run over 1000 tests in 24 hours, attaining first results in about 3 hours.1†

    The Panther Fusion® SARS-CoV-2 assay is a real-time PCR test and the Aptima® SARS-CoV-2 assay utilizes our proprietary TMA® technology. Both assays are intended for the qualitative detection of RNA from SARS-CoV-2 isolated and purified from nasopharyngeal, nasal, mid-turbinate and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal wash, and lower respiratory tract specimens (Panther Fusion assay only) obtained from individuals who meet COVID-19 clinical and/or epidemiological criteria.2,3 These assays are also intended for upper respiratory tract swab samples from individuals without symptoms or other reasons to suspect COVID-19 infection.

    The Aptima SARS-CoV-2/Flu assay utilizes our proprietary real-time TMA chemistry to detect and differentiate SARS-CoV-2, influenza A and influenza B from nasopharyngeal and nasal swabs obtained from individuals with signs and symptoms of a respiratory tract infection or who meet COVID-19 clinical and/or epidemiological criteria.4

    Solutions to meet your COVID-19 testing needs.

    The symptoms of COVID-19 overlap substantially with those of influenza and other respiratory viruses making it impossible to diagnose based on these symptoms alone.5 

    Hologic’s flexible respiratory test menu allows a single patient specimen to be tested for SARS-CoV-2 as well as other common respiratory viruses on a single, high-throughput, fully-automated platform, boosting efficiency and increasing clinical insight. Additionally, when you leverage both the power of Panther and Panther Fusion systems to run your SARS-CoV-2 assays your lab can:

    • Run more efficiently with full automation from sample-to-result, without batching.

    • Receive easy to interpret results.

    • Run multiple assays from a single specimen.

    • Have the ability to run both Aptima and Panther Fusion assays alongside each other at the same time.

    With the added asymptomatic distinction, and symptomatic sample pooling, the Hologic SARS-CoV-2 assays offer a vital tool in identifying early infection in individuals as well as helping laboratories to deliver increasing numbers of molecular test results more quickly.

    Power of Sensitivity

    A recent report published by the FDA compared more than 50 COVID-19 molecular tests and demonstrated that the Hologic Aptima and Panther Fusion SARS-CoV-2 assays are the most analytically sensitive fully automated, high-throughput molecular tests on the market.6 

    Additionally, the Hologic Aptima and Panther Fusion SARS-CoV-2 assays were the first molecular diagnostic tests specifically authorized for use in both symptomatic and asymptomatic people.2,3

    The U.S. Centers for Disease Control and Prevention (CDC) recently issued a guidance recommending COVID-19 tests for people who have had recent contact with infected individuals, regardless of vaccination status, a key strategy for limiting the spread of the virus.7 With the asymptomatic distinction the Hologic Aptima and Panther Fusion SARS-CoV-2 assays offer a vital tool in identifying early infection in individuals.

    To see other actions Hologic has taken in response to the COVID-19 pandemic visit our Coronavirus update page.

     

    Not all assays are available in every region. Check with your Hologic sales representative for availability.

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    * The Aptima SARS-CoV-2, Panther Fusion SARS-CoV-2 and Aptima SARS-CoV-2/Flu 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, Flu A virus, Flu 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.
    † Number of actual test results per day may vary based on individual lab practices and workflows.
    References: 1. Data on File, Hologic, Inc. 2. Panther Fusion SARS-CoV-2 assay. US package insert AW-21159-001. Hologic, Inc.; 2021. 3. Aptima SARS-CoV-2 assay. US package insert AW-21492-001. Hologic, Inc.; 2021. 4. Panther Fusion SARS-CoV-2/Flu assay. US package insert AW-22364. Hologic, Inc; 2021. 5.CDC. Flu Symptoms & Diagnosis. Last reviewed August 31, 2020. Accessed August 13, 2021. https://www.cdc.gov/flu/symptoms/index.html. 6. U.S. Food and Drug Administration. SARS-CoV-2 Reference Panel Comparative Data. Last reviewed December 7, 2020. Accessed August 13, 2021. https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-reference-panel-comparative-data 7. CDC COVID-19 Testing Overview Accessed August 13, 2021 https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/testing.html

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