Hologic Announces FDA Approval of Aptima® CMV Quant Assay for Human Cytomegalovirus

— Hologic’s first quantitative test for transplant pathogen monitoring standardizes clinical information to help enhance patient outcomes —

MARLBOROUGH, Mass.–(BUSINESS WIRE)–#Aptima–Hologic, Inc. (Nasdaq: HOLX) announced today that the U.S. Food and Drug Administration (FDA) approved its Aptima CMV Quant assay to quantify the viral load of cytomegalovirus (CMV) in patients who have had solid organ or stem cell transplants. The test is the first to be introduced in the U.S. by Hologic for post-transplant pathogen detection and monitoring on Hologic’s fully automated Panther^® system, and joins the existing portfolio of diagnostic and viral load testing for HIV-1, Hepatitis C and Hepatitis B.

“We have a legacy of innovation in viral load testing, and our Aptima CMV Quant assay is the first in a series of planned quantitative assays to support patient care following transplant surgery,” said Michelle Garsha, President, Diagnostic Solutions at Hologic. “We’re committed to providing our laboratory partners with superior solutions that improve workflow efficiency, support provider and patient needs and address the challenges faced by today’s molecular lab.”

CMV is a common virus that typically causes mild or asymptomatic infections in people with healthy immune systems. However, transplant recipients typically are artificially immunosuppressed to prevent transplant rejection, which makes them more vulnerable to infections. If left untreated, CMV infection can lead to severe disease, transplant rejection and even death. Guidelines from the American Society of Transplantation and the World Health Organization recommend CMV monitoring as standard of care to help guide treatment decisions for transplant patients, depending on their risk and transplant organ type.^1-2

“It is imperative to have highly accurate, reproducible results to monitor viral load trends of CMV infections over time in plasma of transplant patients,” says Karen Harrington, PhD, Head of Scientific Affairs for Diagnostic Solutions at Hologic. “Our assay aligns with the international quantitative standards, offering laboratories and healthcare providers confidence in the results each and every time, ultimately helping to enhance patient management and outcomes.”

The Aptima CMV Quant assay also is CE-marked for diagnostic and viral load monitoring use in Europe. Hologic intends to pursue regulatory approvals for other transplant assays that are currently in development, including BK Virus and Epstein-Barr Virus. Learn more about Aptima virology assays.

About the Panther System

The Panther system for molecular diagnostics is a best-in-class fully automated, sample-to-result platform with adaptable workflow options and consolidated testing menu. The Panther Fusion^® system provides an expanded in-vitro diagnostics (IVD) menu, as well as Open Access™ functionality to run laboratory-developed tests (LDTs). Hologic’s Panther and Panther Fusion systems now offer 19 FDA-cleared, approved, and authorized assays and up to 21 assays outside the U.S. depending on the region. This high-throughput molecular diagnostic platform combines comprehensive sexual health, cervical health, viral load, respiratory testing and open channel functionality on a fully automated system.

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, Panther and Panther Fusion are registered trademarks of Hologic, Inc. in the United States and/or other countries.

SOURCE: Hologic, Inc.

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References:

1. Kotton, Camille N; Kumar, Deepali; Caliendo, Angela M; Huprikar, Shirish; Chou, Sunwen; Danziger-Isakov, Lara; Humar, Atul (2018). The Third International Consensus Guidelines on the Management of Cytomegalovirus in Solid-organ Transplantation. Transplantation, 102(6):900-931.

2. Razonable AA, Humar A. Cytomegalovirus in solid organ transplant recipients-Guidelines of the American Society of Transplantation Infectious Diseases Community of Practice. Clin Transplant. (2019) 33(9)

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