Hologic Launches Novodiag® System for On-Demand Molecular Testing in Europe

Rhea-AI Summary

Hologic, Inc. has launched the Novodiag^® system across Europe, enhancing its molecular diagnostic solutions portfolio. This fully automated diagnostic tool tests for infectious diseases and antimicrobial resistance, following the acquisition of Mobidiag in June 2021. The Novodiag system utilizes real-time PCR and microarray technologies, allowing for rapid multiple pathogen identification from a single sample. It features a CE-IVD test menu for gastrointestinal infections and SARS-CoV-2 detection, with a strong pipeline of future assays.

Positive

• Launch of Novodiag system broadens Hologic's market reach in Europe.
• Utilizes advanced technology (real-time PCR and microarray) for efficient diagnostics.
• Expands product offering, complementing the Panther® System and meeting diverse customer needs.
• Potential for significant sales growth from the new diagnostic capabilities.

Negative

• Forward-looking statements indicate risks and uncertainties regarding commercial success.
• No assurance that the new products will achieve expected sales levels.

Launch brings Novodiag’s benefits to broader range of European customers and expands Hologic’s offering of world-leading molecular scalable solutions

MANCHESTER, England--(BUSINESS WIRE)-- Hologic, Inc. (Nasdaq: HOLX) today announced its broad European launch of the Novodiag^® system, a fully automated molecular diagnostic solution for on-demand testing of infectious diseases and antimicrobial resistance. The launch follows Hologic’s acquisition of Mobidiag Oy in June 2021 and will bring the benefits of the Novodiag system to a broader range of customers in Europe.

The Novodiag system combines real-time PCR and microarray capabilities. This enables multiple pathogens to be identified in a single sample, providing a simple and fast way to pinpoint patients most at risk with targeted and syndromic on-demand testing. Its CE-IVD test menu includes highly multiplexed on-demand assays detecting gastrointestinal infections and antibiotic resistance, as well as a targeted assay for the detection of SARS-CoV-2. A strong pipeline is also in development.

“Our acquisition of Mobidiag was aimed at strengthening our international diagnostics business. With the Hologic launch of the Novodiag system, we are delivering against this goal,” said Jan Verstreken, Group President, International at Hologic. “The addition of the Novodiag system to our diagnostic molecular scalable solutions portfolio will offer more customers in Europe a wider choice of solutions that meet their needs, from single patient rapid testing to population-level screening.”

Hologic’s current diagnostic offering is anchored by the Panther^® System, a best-in-class, fully automated, sample-to-result platform designed to be used across laboratories of varying throughputs. The Novodiag system is a high multiplex technology that is precision-engineered for simplicity, accuracy and affordability across a broad and growing menu of high- and low-plex assays. It complements the Panther System, along with Panther Scalable Solutions, and expands Hologic’s offering, allowing the Company to meet customers’ growing diagnostic testing needs from small to the largest laboratories.

Tuomas Tenkanen, CEO, Mobidiag, a Hologic company said, “Mobidiag is already realizing the benefits of being part of the Hologic family, and today’s launch will allow Novodiag to reach a far broader customer market faster, delivering the benefits of an on-demand system that offers ease of use, high multiplex capability and a rapid turnaround time.”

For more information visit https://www.hologic.com/hologic-products/novodiag-system.

About Hologic, Inc.

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, Mobidiag, Novodiag, Panther and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries.

Forward Looking Statements

This news release may contain forward-looking information that involves risks and uncertainties, including statements about launching the Novodiag system and related assays. There can be no assurance that these products will achieve the benefits described herein, that they will be commercially successful or achieve any expected level of sales, or that these efforts will be successful, benefit the Company and its stockholders, or improve over time. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any changes in expectations or events, conditions or circumstances on which any such data or statements are based.

SOURCE: Hologic, Inc.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211005005411/en/

Hologic

Investor Contact:

Michael Watts

+1 858.410.8588

michael.watts@hologic.com

Media Contact:

Jane Mazur

+1 508.263.8764 (direct)

+1 585.355.5978 (mobile)

jane.mazur@hologic.com

Source: Hologic, Inc.

FAQ

What is the Novodiag system launched by Hologic?

The Novodiag system is a fully automated molecular diagnostic solution for on-demand testing of infectious diseases and antimicrobial resistance.

When did Hologic acquire Mobidiag?

Hologic acquired Mobidiag in June 2021.

What are the key features of the Novodiag system?

The Novodiag system combines real-time PCR and microarray capabilities, allowing for the detection of multiple pathogens from a single sample.

What markets will the Novodiag system serve?

The Novodiag system is aimed at a broader range of customers across Europe.

What is the stock symbol for Hologic?

The stock symbol for Hologic is HOLX.