Hologic Transplant Assays

    Reliable assays on a fully automated, efficient system

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      Overview

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      Our Portfolio

      Give patients a better chance at life with our Transplant Portfolio of quantitative tests for the quantification of post-transplant infections.

      Aptima® CMV Quant Assay

      Assays such as the Aptima CMV Quant assay can be run on the Panther® System in parallel with the FDA-approved Aptima® virology assays, enabling a consolidated, streamlined workflow. Our reproducible and precise assays reduce inter-assay variability, bringing the lab a step closer to commutability and standardization.

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      A Powerful Solution for Optimal Productivity and Growth

      Scalable automation is key to maximizing your laboratory’s productivity. Panther® Scalable Solutions consolidate all transplant assays on one highly efficient platform. The entire transplant portfolio can be run in conjunction  with other viral assays, ensuring streamlined laboratory workflows.

      The Aptima CMV Quant assay is an in vitro nucleic acid amplification test that uses real-time transcription mediated amplification (TMA) technology on the Panther system to quantify CMV DNA, genotypes 1,2,3 and 4. It involves 3 main steps, which take place in a single tube on the Panther system: target capture, target amplification by TMA, and detection of the amplification products (amplicon) by the fluorescently labeled probes (torches).

      Soon we will offer highly sensitive EBV and BKV assays for the quantification of post-transplant infections. These will be run on Panther Fusion® and leverage polymerase chain reaction (RT-PCR) technology.
       

      Learn how Panther Scalable Solutions empower your lab to grow.

      Consolidate Your Assay Menu

      Our assays help guide patient care and enable early detection. With a menu and pipeline of world-class assays, you can consolidate your molecular testing today and meet your lab’s growing needs tomorrow.

      Infectious Disease

      HIV-1 Quant DX

      HCV Quant DX

      HBV Quant

      CMV Quant

      Flu A/B/RSV

      Paraflu

      AdV/hMPR/RV 

      SARS-CoV-2*

      SARs-CoV-2/Flu/A/B*

      EBV

      BKV

      SARS-CoV-2Flu/A/B/RSV

      GI Bacterial

      GI Extended Bacterial

      GI Viral

      GI Parasite

      Disclaimer:

      * The Aptima SARS-CoV-2, Aptima Zika Virus, Aptima SARS-CoV-2/Flu and Panther Fusion SARS-CoV-2 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 Zika Virus assay has been authorized only for the detection of nucleic acid from Zika virus, 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, influenza A virus, influenza 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 Aptima Zika assay 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 of Zika virus and/or diagnosis of Zika virus infection under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. 

      † CE Marked only. Not for sale in the United States.

      Hologic Transplant Assays

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        Overview

        Package Inserts

        Manage Transplant Patients with Confidence

        The Hologic transplant portfolio continues the promise of innovation through life-changing viral testing, now expanded to include critical testing of post-transplant infection monitoring. The Aptima® CMV Quant assay, the Panther Fusion® EBV Quant and Panther Fusion BKV Quant assays support immunocompromised patient management following transplant surgery.  These assays can be run in conjunction with other Aptima and Panther Fusion assays on the same platform. This consolidated menu streamlines workflow, providing a solution to the challenges faced by today's molecular laboratory.

        Aptima® CMV Quant Assay

        Accurate results for a successful patient monitoring and treatment strategy.

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        Panther Fusion® EBV Quant assay

        Simplify the future of transplant testing.

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        Panther Fusion® BKV Quant assay

        A flexible approach to transplant monitoring.

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        Notified Body number and EC REP information wherever applicable.