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 thousands. 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 will enable labs to run over 1000 tests in 24 hours and attain first results in 3.5 hours or less.

The Panther Fusion SARS-CoV-2 assay is a real-time PCR in vitro diagnostic test and the Aptima SARS-CoV-2 assay is an in vitro diagnostic test utilizing our proprietary TMA technology. Both assays are intended for the qualitative detection of RNA from SARS-CoV-2 isolated and purified from nasopharyngeal, nasal and oropharyngeal swab specimens and lower respiratory tract specimens (Panther Fusion assay, only) obtained from individuals who meet COVID-19 clinical and/or epidemiological criteria.1,2

Test More Patients in Less Time

Now your lab can leverage both the power of Panther and Panther Fusions systems with highly sensitive tests that identify the SARS-CoV-2 virus.1,2 Using either the Aptima or Panther Fusion assays, healthcare providers can test for SARS-CoV-2 from the same patient sample and collection vial currently used to diagnose other common respiratory viruses with overlapping COVID-19 symptoms — boosting efficiency and increasing clinical insight.

Flex Your Ability

  • Fully automated from sample-to-result, with easy to interpret results.

  • Run multiple assays from one specimen.

  • Detect and differentiate between other respiratory illnesses.

  • Run alongside other PCR and TMA assays simultaneously.

Verified Sample Collection Types1,2

For use with nasopharyngeal, nasal and oropharyngeal swab samples.

  • ✓ BD Universal Viral Transport System
  • ✓ COPAN Universal Transport Medium
  • ✓ Remel MicroTest M4, M4RT, M5 or M6 formulations
  • ✓ Saline
  • ✓ Liquid Amies
  • ✓ Aptima® Multitest Swab Specimen Collection Kit§

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

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.3

What is known is that accurate tests are needed to help mitigate the spread of this global pandemic. Learn more about the Aptima and Panther Fusion SARS-CoV-2 assays and how we can help you react quickly to this emerging health threat.

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

† The Panther Fusion SARS-CoV-2 assay is available for EUA use in the United States, Australia, New Zealand, and Canada only.  EUA does not apply to the European Union. The Aptima SARS-CoV-2 assay is available for EUA use in the United States.

‡ Number of actual test results per day may vary based on individual lab practices and workflows.

§ For oropharyngeal and nasal sample types.

References: 1. Panther Fusion SARS-CoV-2 assay [package insert]. AW-21159-001 Rev. 003. San Diego, CA: Hologic, Inc; 2020. 2. Aptima SARS-CoV-2 assay [package insert]. AW-21492-001 Rev.001. San Diego, CA: Hologic, Inc; 2020. 3. 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
Web-01036-001 Rev.003
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