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

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

Manchester, UK, October 5, 2021 – 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. 

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Amplidiag® and Novodiag® solutions now available through distribution in Norway

Mobidiag Ltd. today announces that it has signed an agreement with XboXLab for the distribution of its molecular diagnostic products Amplidiag® and Novodiag® in Norway.

We are very pleased to expand our distribution network and be able to provide Norwegian clinical laboratories with our innovative molecular diagnostic solutions.

For more information, please contact :
Henning Jansen
+47 40 33 00 11
henning.jansen@xboxlab.no
www.xboxlab.se

Mobidiag products are also available throughout Europe and the Middle East. Visit our Distributor page to learn more.

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Development of Novodiag® assay for safe and easy molecular testing of novel coronavirus and influenza viruses

Novodiag® assay rapidly detects coronavirus and influenzas;
provides safety for users with a closed system;
easy to use with no need for highly trained personnel in high risk and hard to reach areas

Mobidiag Ltd. today announces that it has initiated development of a Novodiag® molecular diagnostic test for the rapid and simultaneous detection of the novel coronavirus (strain 2019-nCoV) and influenza viruses.

The assay is being developed in partnership with Autobio Diagnostics (Autobio), the market leading Chinese clinical diagnostics company, and Automobi Molecular Diagnostics (Automobi), the joint venture launched by Mobidiag and Autobio in May 2019.

The new Novodiag® test will operate using a rapid ‘sample-in, result-out’ system, allowing the rapid detection of both novel coronavirus and influenzas in around 30 minutes. In addition, the fully automated system protects laboratory staff and healthcare providers from possible contamination. The user-friendly nature of the system will mean that the Novodiag® platform can be delivered to and will be targeted for use in high risk and hard to reach areas without the need for highly trained personnel.

Tuomas Tenkanen, CEO of Mobidiag, said, “It is vital that molecular diagnostics solutions be utilized to fight back against novel coronavirus which has emerged as a significant threat to health across the world. Our new Novodiag® assay will uniquely offer rapid and fully automated molecular profiling to simultaneously detect novel coronavirus and common influenza strains and guide clinicians more quickly towards moving patients to efficient isolation measures and make better-informed treatment decisions, in situations where time is critical.”

“Our partner Autobio’s understanding of the developing situation in China, combined with our in-house expertise and flexibility of the Novodiag® platform, means we are well positioned to develop an effective diagnostic solution for such a global health emergency. Regulators around the world have recognized the need to expedite responses to the diagnosis and treatment of novel coronavirus and we intend to bring our test to market as rapidly as possible.”

Fu Guangyu, Director of Autobio and General Manager of Automobi, said, “To control the spread of 2019-nCov as soon as possible, a rapid, safe, and accurate etiological diagnosis technique is of paramount need. We are delighted that Mobidiag will use its expertise and know-how to develop an assay that can be used on the Novodiag® platform at this critical time. Autobio and Automobi will work closely with Mobidiag by sharing relevant technology, experience, resources and information in order to ensure we make a meaningful impact in the fight against the spread of 2019-nCov.”

The development of this new assay highlights the broad flexibility and applicability of the Novodiag® platform which combines real-time PCR and microarray technologies to allow for single to high-plex (100+) diagnostics, enabling future applications in areas such as infectious diseases, sepsis and oncology. It conducts comprehensive screening of multiple or single pathogens within approximately one hour, helping to deliver early treatments to patients and avoid the spread of infection.

About Autobio

Autobio Diagnostics Co., Ltd was established in 1998 and has become one of the largest and fastest growing clinical diagnostics companies in China. Autobio specialises in research & development, production, marketing and service of clinical diagnostic products, especially immunoassay, microbiology and biochemical products. Autobio provides comprehensive solutions for medical laboratories. Autobio was listed on Shanghai Stock Exchange on September 1st, 2016.

Autobio has more than 3700 staff and is headquartered in Zhengzhou, China. To learn more, visit www.autobio.com.cn

 

About AutoMobi

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Mobidiag signs new international agreements for distribution of its Amplidiag® and Novodiag® diagnostic solutions

Agreements signed in Poland, Ukraine, Romania and Israel, with more in discussions.

ESPOO, Finland, October 29th, 2019 – Mobidiag Ltd., a molecular diagnostics company with complementary platforms that address antimicrobial resistance and other areas of unmet diagnostic need, today announces that it has signed new exclusive agreements with international partners for the distribution of its Amplidiag® and Novodiag® products in Europe and the Middle East.
Mobidiag has signed exclusive agreements for the distribution of Amplidiag® and Novodiag® with ALAB Ltd. for Poland and Ukraine, BIOgenetiX for Romania and Theranostica Ltd. for Israel.

Tuomas Tenkanen, CEO of Mobidiag, said “We are extremely pleased to have further expanded our commercial footprint into additional international territories. Our highly versatile and complementary Amplidiag® and Novodiag® diagnostic solutions continue to gain traction internationally. We are in ongoing discussions with several distribution partners in a range of international markets as customers look for fast, accurate and affordable diagnostic solutions to a wide range of infectious diseases.”

Gilda Cristea, Imports Manager of BIOgenetiX, comments “It is a great opportunity for BIOgenetiX to collaborate with Mobidiag in Romania. The control of infections and the identification of antibiotic resistant pathogens are critical in all clinical environments. Mobidiag offers a diverse range of products that are easy to use, have great diagnostic precision and are affordable. These products are very important for the general management of patients and hospitals and we see them offering a great opportunity for the future.”

Amnon Hezkaya CEO of Theranostica, continues “We are really excited to start this partnership between Theranostica and Mobidiag. Mobidiag with its Novodiag® solution has the potential to be transformational for Israeli clinical laboratory customers as an affordable, fast sample to result system, which can test multiple targets at once.”

Contacts
Johanna Sarapää, Marketing Communications
+358 10 2054 771
marketing@mobidiag.com

Consilium Strategic Communications
Chris Gardner, Matthew Neal, Chris Welsh
T: +44 (0)203 709 5700
mobidiag@consilium-comms.com

Notes to editors

About Mobidiag Ltd.
Mobidiag is a revenue generating, fast growing molecular diagnostics company with complementary platform technologies that can meet the differing diagnostic needs for customers in multiple healthcare settings. Initially designed for ease of use and adapatability for large scale manufacturing, Mobidiag’s Amplidiag® and Novodiag® platforms provide a combination of high quality and affordability, allowing for widespread applicability for both mass screening and highly specific syndromic testing in multiple indications. The Company’s highly versatile product offering enables the broad application of molecular diagnostics to address the global challenge of antimicrobial resistance and other unmet diagnostic needs. Mobidiag’s intial focus has been on gastrointestinal diseases and superbugs, through direct sales and distributors, and is rapidly building a leading position in European markets.

Mobidiag has more than 100 staff and is headquartered in Espoo, Finland, with subsidiaries in France, UK and Sweden. To learn more, visit www.mobidiag.com

About ALAB Ltd.

ALAB Ltd. based in Warsaw, Poland is a specialized company operating in the laboratory market in Poland and Ukraine. ALAB Ltd. is a member of ALAB GROUP including ALAB LABORATORIA – a key market player in routine and specialized diagnostics and ALAB PLUS – histopathology laboratory service. For 25 years ALAB Ltd. has been conducting commercial and service activities for public and private institutions. Its specialty is the comprehensive equipping of laboratory rooms in biotechnology, molecular biology, physico-chemical, microbiology and diagnostics.

About BIOgenetiX

BIOgenetiX is a distribution company for medical products in Romania. The company provides products and technical support for laboratories performing molecular biology diagnostic tests. BIOgenetiX addresses both state owned and private clinics, laboratories and hospitals. The company was established in 2009 and at the moment it is one of the most important Romanian companies in the field of medical products distribution. BIOgenetiX has a special program in the area of infections control and prevention. The company is focused on providing customers with more advanced technologies for molecular diagnostics and resistance genes identification.

Theranostica Ltd.

Theranostica Ltd., established in 2010 is a leading Israeli distributor for innovative clinical diagnostics solutions from the United States, Europe and Asia. In the past nine years Theranostica has been succesful in bringing to the Israeli health system dozens of new technologies which helped to provide better medicine.

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NEW! Novodiag® Stool Parasites, comprehensive and cost-effective molecular diagnostic test for detection of intestinal parasites

CE-IVD marking of Novodiag® Stool Parasites, the 4th molecular test on the automated system Novodiag®, for detection of the most common protozoan, helminths and microsporidia in one single test.

ESPOO, Finland, October 09, 2019 – Mobidiag Ltd., a revenue generating, molecular diagnostics company with complementary platforms that address antimicrobial resistance and other areas of unmet diagnostic need, today announces the CE-IVD marking of the Novodiag® Stool Parasites test, a comprehensive and cost-effective molecular diagnostic test for the detection of intestinal parasites directly from stool samples.

Tuomas Tenkanen, CEO of Mobidiag, said, “Parasitic diseases contribute significantly to the burden of infectious diseases worldwide and current diagnostic methods such as microscopy are labor-intensive and require a high level of skill. Our Novodiag® Stool Parasites test is the only fully automated, rapid, cost-effective and easy to use diagnostic solution that can identify a comprehensive range of parasitic targets, for use in laboratories and hospitals.”

“Novodiag® Stool Parasites is the fourth test on our Novodiag® platform and, together with our Novodiag® C. difficile, Novodiag® Bacterial GE+ and Novodiag® CarbaR+ tests, further strengthens our offering in the detection of gastrointestinal infections. With our complementary Amplidiag® and Novodiag® solutions, we continue to offer a range of highly versatile combined solutions enabling the broad application of molecular diagnostics around the world.”

Novodiag® Stool Parasites combines real-time PCR and microarray technologies to allow cost-effective, rapid and comprehensive detection of >95% of intestinal parasites. This syndromic test is designed to run on-demand using the automated Novodiag® system and is able to detect the presence of nucleic acid markers corresponding to the identification of the most common protozoan, helminths, and microsporidia from stool samples. The test provides complete results in 90 minutes with less than five minutes hands-on time by an operator.
While most infections and death from parasitic diseases affect people in developing countries, increasing incidence in developed nations combined with a shortage of microscopy trained hospital staff are driving demand for this test.

The Novodiag® Stool Parasites test is now available directly through Mobidiag and local distributors. For more information, visit product page.

About Novodiag® Stool Parasites
Novodiag® Stool Parasites is an automated qualitative nucleic acid-based diagnostic test for detecting the presence of nucleic acid markers corresponding to the identification of the most common protozoan, helminths, and microsporidia from stool samples. It is part of the Novodiag® platform, Mobidiag’s fully automated molecular testing platform for diagnostics of infectious diseases and antibiotic resistances. Combining real-time PCR and microarray technologies, Novodiag® platform allows direct analysis of a patient sample placed in a disposable cartridge for comprehensive screening of multiple or single pathogens. In addition of Novodiag® C. difficile, Novodiag® Bacterial GE+ and Novodiag® CarbaR+, we launch a new test, the Novodiag® Stool Parasites which complements our offer for gastrointestinal infections. Our panel covers >95% of stool parasites.

About Mobidiag Ltd.
Mobidiag is a revenue generating, fast growing molecular diagnostics company with complementary platform technologies that can meet the differing diagnostic needs for customers in multiple healthcare settings. Initially designed for ease of use and adaptability for large scale manufacturing, Mobidiag’s Amplidiag® and Novodiag® platforms provide a combination of high quality and affordability, allowing for widespread applicability for both mass screening and highly specific syndromic testing in multiple indications. The Company’s highly versatile product offering enables the broad application of molecular diagnostics to address the global challenge of antimicrobial resistance and other unmet diagnostic needs. Mobidiag’s intial focus has been on gastrointestinal diseases and superbugs, through direct sales and distributors, and is rapidly building a leading position in European markets.

Mobidiag has more than 100 staff and is headquartered in Espoo, Finland, with subsidiaries in France, UK and Sweden. To learn more, visit www.mobidiag.com

Contacts

Johanna Sarapää, Marketing Communications
+358 10 2054 771
marketing@mobidiag.com

Consilium Strategic Communications
Chris Gardner, Matthew Neal, Chris Welsh
T: +44 (0)203 709 5700
mobidiag@consilium-comms.com

Read full press releases in English, Finnish and French:

191009 Novodiag Stool Parasite Launch_in English
191009 Novodiag Stool Parasite Launch_in Finnish
191009 Novodiag Stool Parasites Launch_in French

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Novodiag® CarbaR+ featured in Biomedical Scientist magazine – Complete evaluation by Nottingham University Hospital QMC

The article features the successful evaluation of Novodiag® CarbaR+ conducted by Nottingham University Hospitals, NHS Trust, Clinical Microbiology, Queen’s Medical Centre.

Shova Sharma, Associate Practitioner & Experimental Lead of the evaluation and Su Sewaa, Deputy Service Manager of NUH QMC have recently evaluated the test and their results are featured in this month´s Biomedical Scientist issue. NUH Clinical Microbiology will be publishing poster of the evaluation in October 2019 at EMMD in the Netherlands.

Novodiag® CarbaR+ is the most extensive test panel for the rapid screening of the most clinically relevant carbapenemases and colistin resistance. Learn more about Novodiag® and Novodiag® CarbaR+.

Read full article here

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Mobidiag´s Novodiag® CarbaR+ test is one of the finalists at the International Medtech Insight Award 2019

Delighted to announce that Mobidiag´s Novodiag® CarbaR+ test has been shortlisted for Best Technological Innovation: Diagnostics at the 2019 Medtech Insight Awards.

“This Award will recognize the efforts of an individual, team, or company that developed an innovative medical device or diagnostic that makes significant contributions to advancing patient treatment. The judges will be looking for the product that represents the most innovative new approach to care by addressing an unmet clinical need; by changing the practice of health care to be more effective, efficient or less error-prone; or by expanding technology to new patient populations.”

Read more information.

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Mobidiag signs exclusive agreement with Pro Med Diagnostics for the distribution of Amplidiag® and Novodiag® diagnostic solutions in Africa

Agreement signed for South Africa, Namibia, Botswana, Zimbabwe, Swaziland, Lesotho, Malawi, Kenya, Uganda

ESPOO, Finland, July 1st, 2019 Mobidiag Ltd. today announces that it has signed an exclusive agreement with Pro Med Diagnostics for the distribution of its Amplidiag® and Novodiag® products in African countries including South Africa, Namibia, Botswana, Zimbabwe, Swaziland, Lesotho, Malawi, Kenya and Uganda.

Tuomas Tenkanen, CEO of Mobidiag, said “We are excited to further expand our commercial footprint into Africa, which represents a fast growing market for diagnostic products with enormous growth potential. We are focused on continuing to develop our distributor network as part of our strategy to make our IVD tests and instruments accessible to customers in centralized and decentralized settings around the world. With a strong background in molecular diagnostics and an extensive customer network, Pro Med Diagnostics is the ideal partner to distribute our products throughout Africa.”

Pro Med Diagnostics founders Neil and Anne Barker, said “We are looking forward to expanding our current product offering by including the novel Mobidiag platform and tests – the ease of use and proven reliability of this platform offers our customers the option of expanding test offerings with minimal fuss and disruption to their current testing algorithms. Fast time to result is crucial in ensuring better patient outcomes. We are proud to be partnering with this strongly positioned product brand, which will further cement our position within the current medical diagnostic market.”

Contacts

Mobidiag

Dorothee Allard

T: +33 (0)1 55 25 17 13

marketing@mobidiag.com

Consilium Strategic Communications

Chris Gardner, Matthew Neal, Chris Welsh

T: +44 (0)203 709 5700

mobidiag@consilium-comms.com

Pro Med Diagnostics

Anne Barker

anne.barker@pro-med.co.za

Notes to editors

About Mobidiag Ltd

Mobidiag is a commercial stage, fast growing molecular diagnostics company whose affordable, widely applicable and robust technology makes the power of molecular diagnostics available to address the spread of antimicrobial resistance (AMR) by rapid detection of pathogens and their potential resistance to antibiotics. Through its Amplidiag® and Novodiag® solutions, Mobidiag offers a comprehensive range of fast, reliable and cost-effective molecular diagnostic solutions for the detection of infectious diseases to laboratories of all sizes.

Mobidiag is headquartered in Espoo, Finland, with subsidiaries in France, UK and Sweden. To learn more, visit www.mobidiag.com.

About Pro Med Diagnostics (Pty) Ltd.

Pro Med Diagnostics is a Medical Diagnostic company specialising in the supply of laboratory based diagnostic products in the field of Fungal and Infectious diseases.

The founders of Pro Med Diagnostics, Neil and Anne Barker, have worked within the Medical Diagnostic field for all of their professional careers bringing a wealth of knowledge and experience to the organisation. Pro Med Diagnostics focuses on delivering an optimal level of customer support from the supply of quality products and service delivery.

Access full pdf version in English.

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Mobidiag signs multiple international agreements for distribution of its Amplidiag® and Novodiag® diagnostic solutions

Agreements signed in Greece, Latvia, Lithuania and Kuwait, with more in discussions

Mobidiag Ltd.announced today that it has signed multiple exclusive agreements with international partners for the distribution of its Amplidiag® and Novodiag® products in Europe and the Middle East.
Mobidiag has signed exclusive agreements for the distribution of Amplidiag® and Novodiag® with Helix2 for Greece and Interlab INTERAUTOMATIKA UAB for Latvia and Lithuania. Mobidiag has also signed its first agreement in the Middle East with Ibn Rushd Medical & Scientific Equipment Co. for the distribution of Novodiag® in Kuwait. The agreements are effective immediately and initially in place for a period of two years.

Tuomas Tenkanen, CEO of Mobidiag, said “We are delighted to have extended our commercial footprint into new international territories including our first agreement in the Middle East. Mobidiag continues to see demand grow for the Amplidiag® and Novodiag® solutions and we are in discussions with several distribution partners in a range of international markets, as customers look for comprehensive diagnostic solutions to a wide range of infectious diseases in both centralised and decentralised laboratories.”

 

Contacts

Mobidiag
Dorothee Allard, Marketing Communications Manager
+33 1 55 25 17 13
marketing@mobidiag.com

Consilium Strategic Communications
Chris Gardner, Matthew Neal, Chris Welsh
T: +44 (0)203 709 5700
mobidiag@consilium-comms.com

 

Read full press release: in English, in French

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