Hologic Respiratory Assays
Flexible, fully automated respiratory testing solutions for improved patient care.
Overview
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Accurate and Customizable Testing for Respiratory Viruses
Since many respiratory infections share common symptoms, it can be difficult to predict which pathogens may be present. Hologic’s menu of Panther Fusion® and Aptima® respiratory assays offer a flexible, mini-panel approach to multiplexed respiratory testing.
With the versatility and automation of the Hologic® respiratory portfolio, your lab can process any combination of our respiratory assays from one patient sample. Provide truly personalized syndromic respiratory testing for your lab and patients with qualitative detection and differentiation of the most common respiratory viruses including Flu A, Flu B, RSV, SARS-CoV-2*, parainfluenzas 1-4, adenovirus, human metapneumovirus, and rhinovirus. The choice is yours.
Discover the Flexibility of Hologic’s Multiplexed Assays
Expand your respiratory capabilities year-round; process as few as 1 or up to 1,000 samples in 24 hours with scalable automation.1
Personalize Testing
Eliminate unnecessary patient costs and only test for what they need. Test one sample across several disease states with a customizable multiplexed assay menu.
Automate Processing
Do more without extra personnel. Increase your walk-away time with Hologic’s direct load tubes and increase efficiency with random and continuous access on the fully automated Panther® system.
Optimize Operations
Streamline your lab’s workflow. Consolidate assays on a single platform with ready-to-use Panther Fusion® reagents that have 60-day on-board stability and up to 32 assay reagent kits on board.
Why Hologic’s Respiratory Assays?
Hear from customers who trust Hologic’s Respiratory assays and direct load collection devices during respiratory season and beyond.
"With Panther, I am able to manage unpredictable COVID surges along with the routine testing that we have on a daily basis.”
Customized Syndromic Respiratory Testing
The Panther Fusion and Aptima assays provide the flexibility to run patient-specific targets, allowing for personalized patient testing and better cost control in your lab. Protect patient and population health with tailored respiratory testing solutions.
Simplified workflow on a fully automated platform
Detect and differentiate common respiratory viruses from a single sample with flexible testing algorithms unique to our respiratory portfolio.
Aptima® SARS-CoV-2 Assay*
Aptima® SARS-CoV-2/Flu A/B Assay*
Panther Fusion® Flu A/B/RSV Assay
Panther Fusion® AdV/hMPV/RV Assay
Panther Fusion® Paraflu Assay
Panther Fusion® SARS-CoV-2 Assay*
Panther Fusion® SARS-CoV-2/Flu A/B/RSV Assay
Video Resources
Ordering Information
* 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.
References: 1. Data on file. 2. Panther Fusion SARS-CoV-2/Flu A/B/RSV assay. US Package Insert AW-27555. Hologic, Inc.; 2023. 3. Panther Fusion Flu A/B/RSV assay. US package insert AW-16832. Hologic, Inc.; 2019. 4. Panther Fusion AdV/hMPV/RV assay. US package insert AW-28996. Hologic, Inc.; 2023 5. Panther Fusion Paraflu assay. US package insert AW-16833. Hologic, Inc.; 2019. 6. Panther Fusion SARS-CoV-2 assay. US package insert AW-21159. Hologic, Inc.; 2022. 7. Aptima SARS-CoV-2 assay. US package insert AW-21492. Hologic, Inc.; 2023. 8. Aptima SARS-CoV-2/Flu assay. US package insert AW-22364. Hologic, Inc; 2023.
Safety Data Sheets
Package Inserts
Overview
Package Inserts
Resources
Syndromic Respiratory Testing.
Patient-Specific Results.
The Panther Fusion Respiratory assays are the premier set of assays on the Panther Fusion® system. You can provide truly personalized syndromic respiratory testing with qualitative detection and differentiation of the most common respiratory viruses from a single patient sample. Each Panther Fusion Respiratory assay can be processed independently or simultaneously with other Panther Fusion® and Aptima® assays.
The Panther Fusion® SARS-CoV-2/Flu A/B/RSV, Panther Fusion® Flu A/B/RSV, Panther Fusion® Paraflu, Panther Fusion® AdV/hMPV/RV and Panther Fusion® Bordetella assays comprise the CE-IVD respiratory testing menu on the fully automated Panther Fusion system. Each is a multiplex, real-time PCR in vitro diagnostic test. These assays can be run on nasopharyngeal (NP) swab specimens obtained from individuals exhibiting signs and symptoms of a respiratory tract infection.1-5 Additionally, the Panther Fusion® SARS-CoV-2 assay has received Emergency Use Authorization for the detection of SARS-CoV-2 from nasopharyngeal, nasal, mid-turbinate and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal wash, and lower respiratory tract specimens.6
Personalized Respiratory Testing
The Panther Fusion assays provide the flexibility to run patient-specific targets, allowing for personalized patient testing and better cost control in your lab.
- The Panther Fusion® SARS-CoV-2/Flu A/B/RSV assay§ - Qualitative detection and differentiation of SARS-CoV-2, influenza A virus, influenza B virus and respiratory syncytial virus.1
- The Panther Fusion® Flu A/B/RSV assay - Qualitative detection and differentiation of influenza A virus, influenza B virus and respiratory syncytial virus.2
- The Panther Fusion® AdV/hMPV/RV assay - Qualitative detection and differentiation of adenovirus, human metapneumovirus and rhinovirus.3
- The Panther Fusion® Paraflu assay - Qualitative detection and differentiation of parainfluenza 1 virus, parainfluenza 2 virus, parainfluenza 3 virus and parainfluenza 4 virus.4
- The Panther Fusion® Bordetella assay† - Qualitative detection and differentiation of Bordetella pertussis and Bordetella parapertussis.5
- The Hologic® SARS-CoV-2 assays*‡ - Qualitative detection of SARS-CoV-2 virus.6-8
Flex Your Ability
With the Panther Fusion Respiratory assays, a single patient specimen can be tested for SARS-CoV-2 as well as other common respiratory viruses which present with overlapping symptoms, boosting efficiency and increasing clinical insight.
Additionally, when you leverage the power of Panther Fusion, your lab can:
- Run more efficiently with full automation from sample-to-result.
- Receive easy-to-interpret results.
- Personalize syndromic respiratory testing by processing multiple assays from a single specimen.
- Control costs by running only the required assays and reduce expense of unnecessary tests.
- Eliminate the need for reagent preparation with Panther Fusion’s ready-to-use format.
- Reduce waste with 60 day on-board reagent stability.
- Consolidate menu onto a single, fully automated platform with the ability to run both Aptima and Panther Fusion assays alongside each other at the same time.
Resources
Education
* 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.
†The Panther Fusion Bordetella Assay is TGA approved and CE marked, it is not Health Canada approved.
‡The Panther Fusion SARS-CoV-2 Assay is Health Canada and TGA approved, it is not CE marked.
§The Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay is CE marked, it is not Health Canada or TGA approved. In development and not for sale in the U.S.
References: 1. Panther Fusion SARS-CoV-2/Flu A/B/RSV assay. Package insert AW-25328. Hologic, Inc.; 2022. 2. Panther Fusion A/B/RSV assay. Package insert AW-16162 Hologic, Inc.; 2018. 3. Panther Fusion AdV/hMPV/RV assay. Package insert AW-16164. Hologic, Inc.; 2019. 4. Panther Fusion Paraflu assay. Package insert AW-16163. Hologic, Inc.; 2018. 5. Panther Fusion Bordetella assay. Package insert AW-18637. Hologic, Inc.; 2018. 6. Panther Fusion SARS-CoV-2 assay. Package insert AW-21388. Hologic, Inc.; 2021. 7. Aptima SARS-CoV-2 assay. US package insert AW-21492-001. Hologic, Inc.; 2021. 8. Panther Fusion SARS-CoV-2/Flu assay. US package insert AW-22364. Hologic, Inc; 2021.
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