Hologic Receives European CE Mark for Molecular Assay to Quantify Human Cytomegalovirus

–Aptima^® CMV Quant Assay is Hologic’s first test for transplant pathogen monitoring–

MARLBOROUGH, Mass.–(BUSINESS WIRE)– Hologic, Inc. (Nasdaq: HOLX) has received CE mark for its new Aptima^® CMV Quant assay in Europe, the Company announced today. This assay, which quantifies the viral load of human cytomegalovirus (CMV), is intended for use to aid in the diagnosis and management of solid-organ transplant patients and hematopoietic stem cell transplant patients. This in vitro nucleic acid amplification test (NAAT) uses real-time transcription-mediated amplification (TMA) technology on the fully automated Panther^® system and can be used with human plasma and whole blood samples.

“Immunocompromised patients are vulnerable to a range of infections, with CMV a frequent complication, and healthcare providers need to quantify and monitor CMV accurately,” said Jan Verstreken, group president, International. “Our Aptima CMV Quant assay is the first in a new line of Hologic assays for transplant patients and demonstrates our commitment to our laboratory partners to expand our molecular diagnostics business into new segments.”

Human CMV is a common DNA virus that belongs to the herpes family. Its prevalence in the population ranges from 45 to 100% worldwide.^1,2 CMV infections are typically mild or asymptomatic in people with normal immune systems. However, in immunocompromised people such as transplant recipients, CMV is a common cause of morbidity and mortality. CMV, like other herpes viruses, may cause a lifelong latent infection that can sporadically reactivate. In transplant recipients, transfer of latent CMV in the graft or reactivation of latent CMV infection in the host may result in widespread viral replication and dissemination to multiple organs, which is often life-threatening.²

As higher viral loads generally correlate to an increased risk of CMV disease,^3,4 it is crucial that CMV levels are quantitated in transplant patients, in conjunction with monitoring clinical presentation and other laboratory markers. Recent guidelines recommend at least weekly monitoring of CMV viral load post-transplant to guide decisions about starting anti-CMV therapy as well as to monitor response to therapy.^5,6,7 Quantitative nucleic acid amplification testing is the preferred method as it is both rapid and sensitive.

For more information on the Aptima assays, visit www.hologic.com.

About Hologic

Hologic, Inc. is an innovative medical technology company primarily focused on improving women’s health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com.

Hologic Forward-Looking Statements

This press release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic’s diagnostic products. There can be no assurance these products will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient. The actual effect of the use of the products can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. In addition, there can be no assurance that these products will be commercially successful or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such statements are based.

Hologic, The Science of Sure, Aptima, and Panther are registered trademarks of Hologic, Inc. in the United States and/or other countries.

References

¹ Bate SL, Dollard SC, Cannon MJ. Cytomegalovirus Seroprevalence in the United States: The National Health and Nutrition Examination Surveys, 1988-2004. Clinical Infectious Diseases 2010;50:531-540

² Cannon MJ, Schmid DS, Hyde TB. Review of Cytomegalovirus Seroprevalence and Demographic Characteristics Associated with Infection. Reviews in Medical Virology 2010;20:202-13

³ Wills MR, Poole E, Lau B, Krishna B, Sinclair JH. The immunology of human cytomegalovirus latency: could latent infection be cleared by novel immunotherapeutic strategies Cell and Mol Immunol. 2015;12:128-38

⁴ Kotton CN, Kumar D, Caliendo AM, et al. The Third International Consensus Guidelines on the Management of Cytomegalovirus in Solid Organ Transplantation. Transplantation. 2018;102(6):900-931.

⁵ de la Cámara R. CMV in Hematopoietic Stem Cell Transplantation. Mediterranean Journal of Hematology and Infectious Diseases.2016; 20;8(1):e2016031.

⁶ Emery VC, Sabin CA, Cope AV, et al. Application of Viral-Load Kinetics to Identify Patients who Develop Cytomegalovirus Disease After Transplantation. Lancet. 2000; 10;355(9220):2032-6.

⁷ Humar A, Gregson D, Caliendo AM, et al. Clinical Utility of Quantitative Cytomegalovirus Viral Load Determination for Predicting Cytomegalovirus Disease in Liver Transplant Recipients. Transplantation. 1999; 15;68(9):1305-11.

⁸ Razonable RR, Hayden RT. Clinical Utility of Viral Load in Management of Cytomegalovirus Infection After Solid Organ Transplantation. Clinical Microbiology Reviews. 2013; 26(4):703-727.

SOURCE: Hologic, Inc.

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