Expand the hunt for viral targets with precise Aptima® Virology assays
The Aptima Virology portfolio delivers on the Hologic promise of innovation through life-changing viral testing for viruses that impact patients in the United States and across the globe. Aptima Virology assays for HIV-1, HCV and HBV deliver reliable quantitation to aid in the management of these challenging viruses.
As treatment options continue to evolve in the viral space, Hologic has answered the call for highly sensitive nucleic acid amplification tests (NAATs) with Aptima Virology assays on the fully automated Panther® system. Our Aptima Virology portfolio may be run in conjunction with the Aptima STI (sexually transmitted infections) portfolio and Aptima HPV assays. This consolidated menu streamlines workflow, providing a solution to the challenges faced by today's molecular lab.
Applied innovation in virology testing
The Aptima Virology portfolio has a legacy of innovation and leadership in the viral space in the United States. This legacy began with the FDA approval of qualitative NAATs for HIV-1 and HCV in the early 2000s. Menu includes viral load testing for HIV-1, HCV, and HBV. Significant distinguishing accomplishments in the virology market include:
- 1997: Hologic developed technology to be used for the development of the Procleix HIV-1/HCV assay and began a strategic partnership with Grifols.1 Today, 75% of the United States donated blood supply is screened using this technology.1
- 2004: Hologic received the National Medal of Technology and Innovation for blood-testing technologies and systems for the detection of West Nile Virus and identification of HIV-1 and HCV in human blood plasma and organ donors.2
- 2006: Hologic gained FDA approval for the Aptima HIV-1 RNA qualitative assay and launched the Aptima HCV RNA qualitative assay.3,4
- 2016: FDA approval for the Aptima® HIV-1 Quant assay.5
- 2017: FDA approval for the Aptima® HCV Quant Dx assay.6
- 2018: FDA approval for the Aptima® HBV Quant assay.7
- 2020: FDA approval for the diagnostic claim to the Aptima HIV-1 Quant assay.8
Today, the Aptima Virology portfolio is a critical set of tools that aid in the clinical management of HIV-1, HCV and HBV. Run on the fully automated Panther system, these assays use proprietary real-time transcription mediated amplification (TMA) technology from Hologic.
The Aptima Virology portfolio: Exceptional performance meets full automation
The Aptima viral load assays on the Panther system deliver strong assay performance, industry-leading sensitivity, broad dynamic range and flexibility in sample requirements demonstrated through substantial data and designed with users in mind.6-8
With performance you can count on, the Aptima HIV-1 Quant Dx assay is the FIRST and ONLY dual-claim assay to confirm HIV-1 infection and measure viral load for optimal patient management.8 The Aptima HIV-1 Quant Dx assay offers reliable quantitation of HIV-1 RNA across a broad linear range.8 Now laboratorians can deliver results, so providers can deliver the best-suited treatments for patients
Further expanding the hunt for viral load targets, the Aptima HCV Quant Dx assay features ultrasensitive performance across a wide linear range and all major HCV genotypes. This assay is indicated for use as an aid in the diagnosis of active HCV infection and as an aid in the management of HCV-infected patients undergoing HCV antiviral drug therapy.
The Aptima HBV Quant assay is a molecular HBV treatment management assay with dual-target design. It helps providers guide treatment management for patients with chronic hepatitis B infection who are undergoing antiviral therapy. This unique design allows laboratorians to deliver results in the face of mutations.
Proven assay performance joins Panther system automation
The robust performance of the Aptima viral load assays, demonstrated through substantial data, provides confidence in ensuring excellence in the clinical management of patients. This proven performance, combined with the benefits of Panther system automation, promotes flexibility and operational efficiency for viral load testing success in molecular labs across the world.
To learn more about the Aptima Virology portfolio, visit USAptimaVirology.com.
References: 1. Data on File. Hologic, Inc. 2. National Science & Technology Medals Foundation. Gen-Probe Incorporated: 2004 National Medal of Technology and Innovation: Medicine. https://www.nationalmedals.org/laureates/gen-probe. Accessed November 6, 2020. 3. Aptima HIV-1 RNA Qualitative Assay. US package insert. 501623. Hologic, Inc.; 2015. 4. Aptima HCV RNA Qualitative Assay. US package insert 500237. Hologic, Inc.; 2016. 5. Aptima HIV-1 Quant Assay. US package insert AW-13242-001. Hologic, Inc.; 2016. 6. Aptima HCV Quant Dx Assay. US package insert AW-14498-001. Hologic, Inc.; 2018. 7. Aptima HBV Quant Assay. US-IVD package insert AW-15644-001. Hologic, Inc.; 2018. 8. Aptima HIV-1 Quant Dx Assay. US package insert AW-18107-001. Hologic, Inc.; 2020.
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Aptima® Virology
Information provided on this tab is intended for audiences outside the United States. Consult "USA" tab for products and claims available in the United States.
Expand the hunt for viral targets with precise Aptima® Virology assays
The Aptima Virology portfolio delivers on the Hologic promise of innovation through life-changing viral testing for viruses that impact patients in the United States and across the globe. Aptima Virology assays for HIV-1, HCV and HBV deliver reliable quantitation to aid in the management of these challenging viruses.
As treatment options continue to evolve in the viral space, Hologic has answered the call for highly sensitive nucleic acid amplification tests (NAATs) with Aptima Virology assays on the fully automated Panther® system. Our Aptima Virology portfolio may be run in conjunction with the Aptima STI (sexually transmitted infections) portfolio and Aptima HPV assays. This consolidated menu streamlines workflow, providing a solution to the challenges faced by today's molecular lab.
Applied innovation in virology testing
The Aptima Virology portfolio has a legacy of innovation and leadership in the viral space in the United States. This legacy began with the FDA approval of qualitative NAATs for HIV-1 and HCV in the early 2000s. Menu includes viral load testing for HIV-1, HCV, and HBV. Significant distinguishing accomplishments in the virology market include:
- 1997: Hologic developed technology to be used for the development of the Procleix HIV-1/HCV assay and began a strategic partnership with Grifols.1 Today, 75% of the United States donated blood supply is screened using this technology.1
- 2004: Hologic received the National Medal of Technology and Innovation for blood-testing technologies and systems for the detection of West Nile Virus and identification of HIV-1 and HCV in human blood plasma and organ donors.2
- 2006: Hologic gained FDA approval for the Aptima HIV-1 RNA qualitative assay and launched the Aptima HCV RNA qualitative assay.3,4
- 2016: FDA approval for the Aptima® HIV-1 Quant assay.5
- 2017: FDA approval for the Aptima® HCV Quant Dx assay.6
- 2018: FDA approval for the Aptima® HBV Quant assay.7
- 2020: FDA approval for the diagnostic claim to the Aptima HIV-1 Quant assay.8
Today, the Aptima Virology portfolio is a critical set of tools that aid in the clinical management of HIV-1, HCV and HBV. Run on the fully automated Panther system, these assays use proprietary real-time transcription mediated amplification (TMA) technology from Hologic.
The Aptima Virology portfolio: Exceptional performance meets full automation
The Aptima viral load assays on the Panther system deliver strong assay performance, industry-leading sensitivity, broad dynamic range and flexibility in sample requirements demonstrated through substantial data and designed with users in mind.6-8
With performance you can count on, the Aptima HIV-1 Quant Dx assay is the FIRST and ONLY dual-claim assay to confirm HIV-1 infection and measure viral load for optimal patient management.8 The Aptima HIV-1 Quant Dx assay offers reliable quantitation of HIV-1 RNA across a broad linear range.8 Now laboratorians can deliver results, so providers can deliver the best-suited treatments for patients
Further expanding the hunt for viral load targets, the Aptima HCV Quant Dx assay features ultrasensitive performance across a wide linear range and all major HCV genotypes. This assay is indicated for use as an aid in the diagnosis of active HCV infection and as an aid in the management of HCV-infected patients undergoing HCV antiviral drug therapy.
The Aptima HBV Quant assay is a molecular HBV treatment management assay with dual-target design. It helps providers guide treatment management for patients with chronic hepatitis B infection who are undergoing antiviral therapy. This unique design allows laboratorians to deliver results in the face of mutations.
Proven assay performance joins Panther system automation
The robust performance of the Aptima viral load assays, demonstrated through substantial data, provides confidence in ensuring excellence in the clinical management of patients. This proven performance, combined with the benefits of Panther system automation, promotes flexibility and operational efficiency for viral load testing success in molecular labs across the world.
To learn more about the Aptima Virology portfolio, visit USAptimaVirology.com.
References: 1. Data on File. Hologic, Inc. 2. National Science & Technology Medals Foundation. Gen-Probe Incorporated: 2004 National Medal of Technology and Innovation: Medicine. https://www.nationalmedals.org/laureates/gen-probe. Accessed November 6, 2020. 3. Aptima HIV-1 RNA Qualitative Assay. US package insert. 501623. Hologic, Inc.; 2015. 4. Aptima HCV RNA Qualitative Assay. US package insert 500237. Hologic, Inc.; 2016. 5. Aptima HIV-1 Quant Assay. US package insert AW-13242-001. Hologic, Inc.; 2016. 6. Aptima HCV Quant Dx Assay. US package insert AW-14498-001. Hologic, Inc.; 2018. 7. Aptima HBV Quant Assay. US-IVD package insert AW-15644-001. Hologic, Inc.; 2018. 8. Aptima HIV-1 Quant Dx Assay. US package insert AW-18107-001. Hologic, Inc.; 2020.
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