Hologic SARS-CoV-2 Assays

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