Business Wire

MA-HOLOGIC

Share
Hologic Obtains European CE Mark for Use of Saliva Samples with COVID-19 Test

Hologic, Inc. (Nasdaq: HOLX) has obtained a CE Mark for the use of saliva samples with the Aptima® SARS-CoV-2 assay in Europe. The Aptima SARS-CoV-2 test is a molecular diagnostic assay that detects the genetic material of the pathogen causing COVID-19. The test runs on the fully automated Panther® system.

“This new CE Mark demonstrates our commitment to providing European consumers and healthcare providers as many options as possible to manage the ongoing pandemic,” said Jan Verstreken, Hologic’s group president, International. “While vaccination is helping stem the tide of COVID-19, we envision that testing will continue to play an important role, particularly in screening programs needed to reopen society.”

Collection of saliva is easy, noninvasive and painless. The availability of this alternative specimen type should help facilitate screening in schools, workplaces and other settings. Certain European health authorities have determined that the established assay performance with saliva and the ease of obtaining the sample make saliva suitable for programs that use repeated screenings. The Aptima SARS-CoV-2 assay is also CE-marked for use with nasopharyngeal and nasal swabs as well as additional specimen types.

Hologic has expanded manufacturing capability to produce Aptima tests in large quantities and has shipped more than 100 million Aptima COVID-19 tests globally since the spring of 2020. Approximately 2,600 Panther systems have been installed in clinical diagnostic laboratories around the world.

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.

SOURCE: Hologic, Inc.

Link:

ClickThru

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Cyviz Awarded Two Classified NATO Defense Contracts19.12.2025 08:00:00 CET | Press release

Norwegian technology and platform company Cyviz AS has been awarded two classified defense contracts by major European NATO-partner nations to deliver a fully mobile, containerised Command & Control (C2) capability, strengthening Europe’s operational readiness in high-threat and expeditionary environments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251218625485/en/ Image from a previous military exercise where Cyviz demonstrated a mobile command center solution. The contracts cover the design, integration, and delivery of secure, deployable operations centres engineered to NATO security standards, enabling military and security forces to establish full theatre-class command capability wherever operations require. Due to the sensitive nature of the missions, contract value and customer identities remain undisclosed. From Demonstrated Readiness to Operational Deployment The awards follow growing interest among European def

S3NS Announces SecNumCloud Qualification for PREMI3NS, its Trusted Cloud Offering19.12.2025 07:00:00 CET | Press release

PREMI3NS, S3NS’ (pronounced “sense”) trusted cloud offering, has now received ANSSI’s SecNumCloud qualification, meeting the most stringent protection requirements against extraterritorial laws in France and Europe The fruition of the partnership between Thales and Google Cloud enables organizations from the private and public sectors to innovate and transform with one of the broadest ranges of managed services in a trusted cloud environment Early adopters of S3NS include companies from the insurance, manufacturing, healthcare and finance industries S3NS, a subsidiary of Thales in partnership with Google Cloud, today announced that PREMI3NS, its "Trusted Cloud" (Cloud de confiance) offering, has received the SecNumCloud 3.2 qualification delivered by the French National Agency for the Security of Information Systems (ANSSI). Meeting SecNumCloud 3.2’s protection and resilience requirements, which are known as the most demanding ones in France and Europe, it offers immunity from non-Euro

Meiji Seika Pharma Partners With MBC BioLabs to Strengthen Global Innovation in Drug Discovery19.12.2025 02:00:00 CET | Press release

Meiji Seika Pharma Co., Ltd. (Headquarters: Chuo-ku, Tokyo; President & CEO: Toshiaki Nagasato) today announced that it has entered into a partnership agreement with MBC BioLabs which is a private organization supporting the development of biotech startup companies in California’s San Francisco Bay Area. MBC BioLabs provides fully equipped research facilities and a supportive community that help biotech entrepreneurs accelerate from concept to company. By removing the burden of building and maintaining laboratory infrastructure, resident companies can focus early on research and development while efficiently advancing commercialization. Through this partnership, Meiji Seika Pharma will further advance its open-innovation initiatives and strengthen research and development in its priority therapeutic areas: infectious diseases, hematologic diseases, and immune-inflammatory diseases. By engaging with the entrepreneurs and startup community at MBC BioLabs, the company aims to discover inn

Enry's Island SpA Strengthens Its Leadership in Venture Capital with Explosive Growth and Redesigns the Future of VC Through Gaming19.12.2025 00:34:00 CET | Press release

Announcement of Enry’s Island AdVentures: the world’s first video game to learn how to launch and scale startups, focused on democratizing innovation for “Long Tail Users” Enry’s Island SpA (WBAG:EIOS), the world’s first publicly listed venture builder, announces a new era of growth, innovation, and the democratization of Venture Capital (VC). The company has delivered exceptional results, consolidating its position as an industry leader through a strategic positioning in the rapidly expanding gaming market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251218742236/en/ Record Growth and Performance Enry’s Island SpA has demonstrated an extraordinary growth trajectory and a strong financial and operational track record: Revenues: +250% year-over-year (YoY). Exit: $3.6M in exits realized via IPO. Portfolio: 1 IPO of a portfolio company completed in December 2024, with an additional 2 IPOs expected in 2026. The performance of

500 Global Expands Africa Presence; Selected to Advance Digital Morocco 2030 Strategy18.12.2025 21:37:00 CET | Press release

Part of the Digital Morocco 2030 strategy, 500 Global has been selected to support the Startup Venture Building (Startup VB) initiative. 500 Global, one of the world’s most active venture capital firms1, announced it has been selected to support the Ministry-led Startup VB initiative, a flagship program under the Digital Morocco 2030 strategy2. This announcement marks a significant milestone in 500 Global’s continued expansion across the African continent and its work collaborating with governments to strengthen national innovation ecosystems. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251218363323/en/ Announcement of 500 Global's continued expansion across Africa and support of Digital Morocco 2030 Launched by the Ministry of Digital Transition and Administrative Reform (Ministry) and deployed by TAMWILCOM, the Startup VB initiative is a flagship program under the Digital Morocco 2030 strategy. Startup VB aims to streng

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye