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. In response to the desperate public need for rapid high-volume testing we developed SARS-CoV-2 assays on both our Panther® and Panther Fusion® systems.* Both assays enable labs to run over 1000 tests in 24 hours and attain first results in 3.5 hours or less.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

Power of Sensitivity 

A recent report published by the FDA compared more than 50 COVID-19 molecular tests and demonstrated that Hologic’s assays are the most analytically sensitive fully automated, high-throughput molecular tests on the market.4 Additionally, the Hologic 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 guidance recommending COVID-19 tests for people who have had recent contact with infected individuals, a key strategy for limiting the spread of the virus.5 With the asymptomatic distinction the Hologic SARS-CoV-2 assays offer a vital tool in identifying early infection in individuals.

Flex Your Ability

With either the Aptima or Panther Fusion SARS-CoV-2 assays, a single patient specimen can be tested for SARS-CoV-2 as well as other common respiratory viruses with symptoms that overlap with COVID-19 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.  

  • 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.

Verified Sample Collection Types1,2

For use with nasopharyngeal (NP), nasal, mid-turbinate and oropharyngeal (OP) swab specimens, nasopharyngeal wash/aspirate or nasal wash.

  • ✓ Viral transport medium (VTM/UTM)
  • ✓ Saline
  • ✓ Liquid Amies
  • ✓ Specimen transport medium (STM)
  • ✓ Aptima® Multitest Swab Specimen Collection Kit

Additionally, the Panther Fusion assay has been verified for use with lower respiratory tract specimens.

An Accurate Solution for a Novel Virus

While there are still many unknown variables regarding SARS-CoV-2, it’s understood that the virus spreads easily from person-to-person and is believed to live in the air for several hours and on surfaces for as long as two to three days.6

What is known is that sensitive tests are needed to help accurately identify positives and mitigate the spread of this global pandemic. Contact us to learn more about the Aptima and Panther Fusion SARS-CoV-2 assays and how our automated solutions can help your lab respond to this global health emergency.


* The  Aptima® and Panther Fusion® SARS-CoV-2 assays:
• These tests have not been FDA cleared or approved;
• These tests have authorized by FDA under an EUA for use by authorized laboratories;
• These tests haves been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
• These tests 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.

‡ For oropharyngeal and nasal sample types.


References: 1. Data on File, Hologic, Inc. 2. Panther Fusion SARS-CoV-2 assay. US package insert AW-21159-001. Hologic, Inc.; 2020. 3. Aptima SARS-CoV-2 assay. US package insert AW-21492-001. Hologic, Inc.; 2020. 4. U.S. Food and Drug Administration. SARS-CoV-2 Reference Panel Comparative Data. Published September 15, 2020. Accessed September 21, 2020. https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-reference-panel-comparative-data 5. Center of Disease Control. Overview of Testing for SARS-CoV-2 (COVID-19). Published September 18, 2020. Accessed September 28, 2020. https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html 6. Doremalen N, et al. U.S. Government. Aerosol and surface stability of HCoV-19 (SARS-CoV-2) compared to SARS-CoV-1. https://www.medrxiv.org/content/10.1101/2020.03.09.20033217v1.full.pdf. Accessed October 21, 2020.
 
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