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The Aptima HIV-1 Quant Dx Assay Receives Additional FDA Approval for Use as an Aid in Diagnosing HIV Infection | Business AP




Marlborough, Massachusetts-(BUSINESSWIRE)-November 20, 2020-

Hologic, Inc. (Nasdaq: HOLX) today announced that the US Food and Drug Administration (FDA) has approved a request for diagnosis of the HIV-1 (human immunodeficiency virus type 1) virus load monitoring assay. The Aptima® HIV-1 QuantDx Assay is currently the first dual-claim assay in the United States for both diagnostic and viral load monitoring.

Aptima® HIV-1 QuantDx Assay (Photo: Business Wire)

Approved for viral load monitoring in late 2016, the Aptima HIV-1 Quant Dx Assay is a fully automated sample-to-result molecular diagnostic test performed by Panther. ® system. This assay utilizes a dual-target approach to highly conserved regions of the HIV genome and is designed to provide reliable, consistent, qualitative and quantitative results across HIV-1 groups and subtypes. It has been. The Aptima HIV-1 Quant Dx assay also bears the CEIVD mark for both diagnostic and viral load monitoring claims.

“This is an exciting new claim to sensitive and reliable HIV testing because it has the potential to improve patient care,” said Kevin Thornal, president of Hologic’s diagnostic solutions. “By measuring viral load at the same time as diagnosis, healthcare providers can guide treatment choices so that patients can start treatment immediately. The double claim is to test as one as possible. It also benefits clinical laboratory customers who are continually striving to integrate into an automated platform. “

Initiating treatment at the time of diagnosis is expected to reduce the risk of HIV transmission to others and maximize long-term health prospects.

About 1.2 million people are infected with HIV in the United States, and 38,000 are newly infected in 2018. 1

About Panther and Panther Fusion System

The Panther Molecular Diagnostic System is a best-in-class, fully automated sample-to-result platform for use in low-throughput, medium-throughput, or high-throughput laboratories. With a small footprint and integrated test menu with adaptive workflow options, you can combine women’s health, sexually transmitted infections, and viral load tests, all at the same time. Panther Fusion system has been extended In vitro Diagnostic menus and Open AccessTM capabilities for running tests developed in the lab. Hologic’s Panther and Panther Fusion systems currently offer 18 FDA-approved assays and 20 CE-marked assays to detect more than 20 pathogens. Over 2,250 Panther systems are installed in clinical diagnostic laboratories around the world.

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

Description of future prospects

This press release may contain information about future prospects with risks and uncertainties, such as statements regarding the use of Hologic’s diagnostic products. We cannot guarantee that these products will achieve the benefits described in this document or that such benefits will be reproduced in a particular way for individual patients. The actual effect of using the product can only be determined on a case-by-case basis, depending on the particular situation and the patient in question. In addition, there is no guarantee that these products will be commercially successful or achieve the expected level of sales. Hologic expresses its obligation or commitment to publish any updates or amendments to such statements presented in this document to reflect changes in expectations or events, conditions, or circumstances underlying such statements. I deny it.

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

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Vice President of Investor Relations and Corporate Communications

Keywords: United States North America Massachusetts

Industry Keywords: Infectious Diseases FDA AIDS Health

Copyright Business Wire 2020.

PUB: 11/20/2020 08:08 AM / DISC: 11/20/2020 08:08 AM

Copyright Business Wire 2020.


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