Hologic’s Multiplex COVID-19/Flu Test Now Commercially Available in North America and Europe

Rhea-AI Summary

Hologic, Inc. has launched the Aptima® SARS-CoV-2/Flu Assay for simultaneous detection of SARS-CoV-2, influenza A, and influenza B. The assay, CE-Marked for Europe and FDA authorized, provides results in approximately three hours and can process over 1,000 tests daily. This multiplex test addresses the overlap of symptoms between these viruses, enhancing testing options as the flu season approaches. Hologic has distributed over 100 million SARS-CoV-2 assays globally.

Positive

• Launch of Aptima® SARS-CoV-2/Flu Assay enhances testing capabilities.
• FDA Emergency Use Authorization and CE marking received.
• Speedy results in approximately three hours.
• Ability to process over 1,000 tests per day on Panther® system.
• More than 100 million SARS-CoV-2 assays have been provided to labs.

Negative

• Potential risks regarding full market authorization.
• No assurance of meeting demand for the new assay.

- Aptima® SARS-CoV-2/Flu Assay Tests Simultaneously for SARS-CoV-2, Influenza A and B on Fully Automated Panther® Molecular Diagnostics System -

MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Hologic, Inc. (Nasdaq: HOLX) announced today that its Aptima® SARS-CoV-2/Flu Assay is now available for the simultaneous detection and differentiation of three respiratory viruses that can present with overlapping clinical symptoms.

The three viruses – SARS-CoV-2, influenza A and influenza B – typically cause similar symptoms including fever, cough, headache and fatigue¹. With the potential for seasonal flu in addition to the ongoing COVID-19 pandemic, physicians may want to test patients presenting with these shared symptoms for all three viruses.

Hologic’s new multiplex test is CE-Marked for diagnostic use in Europe, authorized under Interim Order by Health Canada, and has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The assay runs on Hologic’s fully automated Panther® system, which provides initial results in approximately three hours and can process more than 1,000 tests in 24 hours.

“Our new assay will provide greater flexibility and testing options for labs and healthcare providers as we head into what is typically flu season in the United States,” said Kevin Thornal, president of the Diagnostic Solutions Division at Hologic. “Because our Panther instruments are so widely placed in clinical labs across the country, the launch of this test will help deliver results where and when they are needed.”

To date, Hologic has provided more than 100 million SARS-CoV-2 assays to its laboratory customers, making a significant contribution to the global testing supply. More than 2,700 Panther systems are installed in clinical diagnostic laboratories around the world.

“Our new SARS-CoV-2/Flu assay is a valuable option for healthcare systems by providing the ability to detect multiple infectious agents simultaneously,” said Jan Verstreken, group president, International at Hologic. “Hologic has been consistently at the forefront of public health needs during the current pandemic by providing fully automated testing capabilities to address the global situation.”

The Aptima ARS-CoV-2/Flu Assay can be used with both anterior nasal swab and nasopharyngeal sample types. Multiple collection devices can be used, including Hologic’s Direct Load Collection Kits, recently launched in the U.S., which are designed to reduce risk of viral transmission and improve laboratory efficiency. A buffer within the collection tube inactivates SARS-CoV-2 and other common respiratory viruses. Then the tubes are loaded directly onto the Panther instrument without any manual steps, reducing human error and repetitive motion injuries.

Development of the Aptima® SARS-CoV-2/Flu Assay was funded in part with federal funds from the U.S. Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract no. 75A50120P00100.

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.

Forward-Looking Statements

This press release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic’s Aptima® SARS-CoV-2/Flu assay and Panther system. There can be no assurance the Aptima® SARS-CoV-2/Flu assay and Panther system will receive full market authorization or achieve the benefits described herein, as applicable. In addition, there can be no assurance that the products will be manufactured in adequate quantities to meet demand, 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, Aptima, Panther and The Science of Sure are registered trademarks of Hologic, Inc. in the United States and/or other countries.

References:

1. https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html. Accessed October 26, 2021.

SOURCE: Hologic, Inc.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211027005952/en/

Investor Contacts

Michael Watts

Vice President, Investor Relations and Corporate Communications

(858) 410-8588

michael.watts@hologic.com

Ryan M. Simon

Vice President, Investor Relations

(858) 410-8514

ryan.simon@hologic.com

Media Contact

Jane Mazur

Vice President, Divisional Communications

(585) 355-5978

jane.mazur@hologic.com

Source: Hologic, Inc.

FAQ

What is the Aptima® SARS-CoV-2/Flu Assay by Hologic?

It is a multiplex test for simultaneous detection of SARS-CoV-2, influenza A, and influenza B, available on the Panther® system.

Where has the Aptima® SARS-CoV-2/Flu Assay received regulatory approval?

The assay is CE-Marked for Europe, authorized by Health Canada, and has received FDA Emergency Use Authorization.

How quickly can the Aptima® SARS-CoV-2/Flu Assay provide results?

The assay can provide initial results in approximately three hours.

How many tests can the Panther® system process with the Aptima® SARS-CoV-2/Flu Assay?

The system can process over 1,000 tests in a 24-hour period.

What are the primary respiratory viruses detected by the Aptima® SARS-CoV-2/Flu Assay?

The assay detects SARS-CoV-2, influenza A, and influenza B.