Category: News

CTK Biotech, part of SSI Diagnostica Group, achieves CE-IVDR approval for key rapid tests, expanding the group’s global footprint and improving patient access to critical diagnostics

SSI Diagnostica Group is proud to announce that CTK Biotech has obtained CE marking under the European In Vitro Diagnostic Regulation for three leading diagnostic tests, the OnSite® Syphilis Ab Combo Rapid Test, OnSite® Dengue Ag Rapid Test, and the OnSite® H. pylori Ag Rapid Test.

This is a significant milestone that allows the group to bring trusted rapid diagnostic tests to even more healthcare professionals – ultimately savings lives and enabling better treatment outcomes for patients worldwide through fast and accurate diagnosis.

As part of SSI Diagnostica Group, CTK Biotech leverages self-developed and proprietary recombinant antigen and antibody production to develop portable, intuitive diagnostic kits that are used globally, including in remote and resource-limited environments. The CTK product portfolio is part of the broader SSI Diagnostica Group portfolio, which also includes rapid diagnostic tests and reagents for a wide range of gastrointestinal and respiratory infectious diseases.

Visit SSI Diagnostica Group at  www.ssidiagnostica.com for more information and to explore the full portfolio of products.

About the tests:

The OnSite® Syphilis Ab Combo Rapid Test is a lateral flow chromatographic immunoassay that qualitatively detects T. pallidum antibodies (IgG, IgM, IgA) in 15 minutes or less, in as early as 2 weeks after infection.

The OnSite® Dengue Ag Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of NS1 antigen from the four known dengue virus serotypes in 15 minutes, aiding in the detection of acute Dengue Fever without the use of laboratory equipment.

The OnSite® H. pylori Ag Rapid Test is a lateral flow chromatographic immunoassay that qualitatively detects H. pylori antigen in 10 minutes or less, without requiring the patient to avoid commonly used GI medications prior to testing.

About SSI Diagnostica Group

SSI Diagnostica Group is a clinical diagnostic company with a mission to help prevent, monitor, and diagnose clinical diseases through quality portfolios of reagents and IVD diagnostic products and solutions. The Group specializes in gastric, respiratory and bloodborne diseases as a leading partner to the IVD and diagnostic industry. The company serves customers globally through its sites in Denmark, the USA, and China.  With a long heritage as a leading developer and manufacturer of rapid diagnostics, CTK Biotech joined SSI Diagnostica Group in 2020.

For all questions and media inquiries, please contact Mie Nete Petersen at:

Email – info@ssidiagnostica.com

Phone – (+45) 48 29 91 00

SSI Diagnostica Group acquires Gulf Coast Scientific – a Florida-based IVD company specialized in Urea Breath Testing for Helicobacter Pylori and further strengthens the Group’s footprint in the US clinical diagnostic market.

SSI Diagnostica Group, a global leading developer and manufacturer of specialized infectious disease diagnostic solutions, is acquiring Gulf Coast Scientific (GCS) located in Florida, USA to further strengthen its gastrointestinal disease testing portfolio.

SSI Diagnostica Group focuses on infectious disease in-vitro diagnostic solutions and antisera and other reagent development for gastric, respiratory and bloodborne diseases. Headquartered in Denmark, the company sells its products in 100 countries worldwide, with direct sales in the Nordics and the USA. It has US locations in California and Virginia with strong R&D capabilities, product development, and state-of-the-art manufacturing from which it serves leading US reference laboratories and hospital labs. GCS specializes in the development of Urea Breath Testing for Helicobacter Pylori (H. Pylori) – a gastric bacteria infecting more than 60 million people annually in the USA alone. The bacteria causes chronic gastritis, gastric cancer, and other cardiovascular and metabolic conditions – diseases critical to detect and treat early at onset to help people live healthier lives.

Acquiring Gulf Coast Scientific complements the company’s gastric portfolio – allowing SSI Diagnostica Group to support its reference and hospital lab customers in the USA and beyond with a broader range of highly specialized products. Jointly, the group will have a total revenue of 850 mDKK (~125 mUSD), growing faster than the market. The company will consist of nearly 600 talented employees across sites in Denmark, the US and China.

Nachum (Homi) Shamir, Chairman of the board, states: “This acquisition demonstrates the potential and capabilities of the SSI Diagnostica Group. It shows our commitment to continue to invest and build our company. Our goal for the next few years is to rapidly grow SSID Group organically and through acquisitions. The USA is a key market, and we are excited to strengthen our position further with additional synergistic quality products in a new technological area.”

The acquisition strengthens the group’s range and technologies for detecting gastric bacterial diseases. Combining the portfolio of Urea Breath Testing and Rapid Solutions for H. Pylori whilst also offering a strong range of testing for other gastric diseases, e.g. C. Difficile, Lactoferrin and other Foodborne Diseases, makes SSI Diagnostica Group able to offer critical diagnostic solutions for patients with similar symptoms – but with unique urgent treatment needs.

“We know our customers – especially in the USA – prefer the option of combining Rapid Antigen Screening solutions and Urea Breath Testing for H. Pylori to cover a broader range of patients with specific sampling needs. Adding GCS to our portfolio truly offers the opportunity to meet our customers’ needs and help serving even more patients with gastric infections” says CEO, SSI Diagnostica Group, Christina Lindved.

Philip Ross, General Manager, GCS adds: “We are very pleased to join SSI Diagnostica Group. The combination of our product ranges allows us to provide many more product offerings to our customers, whilst we, as one group, can reach many more patients with the quality diagnostic solutions needed to mitigate the risk of H. Pylori and other infectious diseases spreading.”.

About SSI Diagnostica Group

SSI Diagnostica Group is a leading global developer and manufacturer of In Vitro Diagnostic solutions for infectious diseases focused on gastric, respiratory and bloodborne conditions. Founded as a division of the renowned Statens Serum Institut, our roots go back to 1902. SSI Diagnostica was privatized in 2016 and supported by Adelis Equity Partners acquired San Diego-based CTK Biotech in 2020, followed by TechLab in 2022. Techlab is a quality In Vitro Diagnostics company specialized in gastric diseases with unique products for e.g. C. Difficile and H. Pylori based out of USA, Virginia. Together, all companies now form SSI Diagnostica Group.

About Gulf Coast Scientific

Gulf Coast Scientific develops, manufactures, and distributes non-invasive diagnostic solutions for the detection of Helicobacter Pylori. Founded in 1996 in Florida, the company has a well-proven record of FDA approved product ranges composed of various samplers, port analyzers, and test tubes. The company has a strong position in the American as well as international markets.

For further information or interview requests please contact:
Mie Nete Petersen, Vice President Global Strategy & Corporate Development, SSI Diagnostica Group
+45 41280905, mnp@ssidiagnostica.com

SSI Diagnostica Group, a global leader in clinical diagnostics for infectious gastric, respiratory and bloodborne diseases, is pleased to announce it has signed a refinancing agreement led by Bridgepoint Credit, one of Europe’s most experienced credit managers with over €14 billion of assets under management.

Nordea and Nykredit, two long-standing and trusted relationship banks, will also participate in the refinancing. The new facilities will refinance the existing debt in full and provide a foundation for M&A and other investments to grow the business and scale the organization.

Christina Lindved, CEO of SSI Diagnostica Group, comments:

“We are delighted to be partnering with Bridgepoint, Nordea, and Nykredit for the next stage of our growth plans. The partnership will allow us to further execute on our 5-year strategic plans and reach even more people in need of quality diagnostic solutions.”

Lars Henrik Vejrup Hansen, Chief Financial Officer of SSI Diagnostica Group, adds:

“The substantial investments in SSI Diagnostica Group are a strong validation of our business model, strategy and growth trajectory. The flexible structure of the financing allows us to operate strategically and invest in longer-term activities.”

The refinancing marks a significant milestone in the company’s growth journey towards reaching more people with quality diagnostic solutions with the aim of improving treatment outcomes globally.

SSI Diagnostica Group has been owned by Adelis Equity Partners since 2016, followed by a reinvestment in 2022 through a continuation vehicle alongside its LPs. The Group was advised on the refinancing by Lazard (financial advisor) and Kromann Reumert (legal advisor).

SSI Diagnostica Group will as of 2nd of January 2025 welcome Lars Henrik Vejrup Hansen as new Group CFO. Lars comes from prior senior financial leadership positions in organizations like Ernst & Young and A. P. Møller Maersk – and most recently from a position as Group CFO at Toms Gruppen A/S.

“I am very pleased to welcome Lars to our organization! Lars has extensive experience in similar financial roles and strong leadership skills – and he will be an excellent fit with our organization, and with the strategy we recently embarked on”, says CEO Christina Lindved.

In 2023, SSI Diagnostica Group introduced a new five-year strategy, focusing on the core business and integration of recent acquisitions. In 2024, this focus on core business growth, combined with increasing realizations of synergies from the acquisitions, has established a solid foundation for SSI Diagnostica Group to accelerate growth in the coming years.

Chairman of the Board, Homi Shamir adds:

“Lars is a valuable addition to the management team as we work towards expanding SSI Diagnostica Group’s global presence and advancing diagnostic solutions to improve treatment outcomes for patients”.

SSI Diagnostica Group is a partner, developer, and manufacturer to the diagnostic industry – experts in clinical diagnostics within infectious diseases. The Group is owned by Adelis Equity Partners.

Blacksburg, VA – June 21, 2024 – TECHLAB, Inc., a part of the SSI Diagnostica Group, is pleased to announce that its C. DIFF QUIK CHEK COMPLETE^® test has received certification under the European In Vitro Diagnostic Medical Device Regulation (IVDR), a first* for a combined GDH plus toxin A/B test.

The C. DIFF QUIK CHEK COMPLETE^® test is a rapid membrane enzyme immunoassay designed for the simultaneous detection of Clostridioides difficile glutamate dehydrogenase (GDH) antigen and toxins A and B in a single reaction well. This innovative test provides both GDH and toxin results within approximately 30 minutes, enabling healthcare professionals to differentiate between active C. difficile infection and colonization in a cost-effective and clinically relevant manner.

“We are proud to achieve IVDR certification for our C. DIFF QUIK CHEK COMPLETE^® test,” said Christina Lindved, CEO of SSI Diagnostica Group, “This achievement underscores SSI Diagnostica’s commitment to delivering high-quality diagnostic tools that meet the stringent regulatory requirements and fulfill the needs of healthcare providers and patients worldwide.”

This certification recognizes the test’s adherence to rigorous quality and safety standards, ensuring its reliability and effectiveness in clinical settings across Europe, and marks a significant advancement in SSI Diagnostica’s efforts to enhance diagnostic capabilities for C. difficile infections.

For more information about the C. DIFF QUIK CHEK COMPLETE^® test and the TECHLAB portfolio of diagnostic solutions, please visit www.techlab.com.  To see the rest of the SSI Diagnostica Group portfolio, please visit www.ssidiagnostica.com.

* This assertion is based on a review of the EUDAMED database, 06/03/2024 at 10:00 am ET USA, which lists IVDR-compliant devices under code W0105011803.

About SSI Diagnostica Group

The SSI Diagnostica Group is a clinical diagnostic company with a mission to help prevent, monitor, and diagnose clinical diseases through quality portfolios of reagents and IVD diagnostic products and solutions. The Group specializes in gastric, respiratory and bloodborne diseases as a leading partner to the IVD and diagnostic industry. The company serves customers globally through its sites in Denmark, the USA, and China.  With a long heritage as a leading developer and manufacturer of intestinal diagnostics, TECHLAB, Inc. joined the SSI Diagnostica Group in 2022.

For media inquiries or further information, please contact:

Jodie Lee, M.S., M.B.A.

Director of Marketing

TECHLAB, Inc., a SSI Diagnostica Group company

Email: marketing@techlab.com

Phone: +1 (540) 953-1664

SSI Diagnostica Group is promoting Mie Nete Petersen to Vice President of Global Strategy & Corporate Development. She has undertaken a crucial role in developing our strategy and long-term growth ambition. Mie has extensive experience from large companies like Novo Nordisk and Coloplast working with strategy, commercial development and marketing before joining SSI Diagnostica in February 2022.

“To accelerate and deliver on our ambitious growth agenda, I’m happy to announce the promotion of Mie Petersen to Vice President. She has been a member of the Global Leadership Team since January 2023 and since then she has been leading the Global Strategy and Corporate Development function. She is a valuable resource to the Leadership, Board and organization. We are lucky to have such talents at SSI Diagnostica Group, and Mie will continue to be an immensely important resource to our growth and success,” says Christina Lindved, Group CEO.

SSI Diagnostica Group’s main goal is to serve the clinical diagnostic market in the effort of preventing, monitoring, and diagnosing people, ultimately supporting better treatment outcomes for patients globally.

In the effort to continuously strengthen the position with customers and be able to serve the IVD Diagnostics industry with quality diagnostics solutions, SSI Diagnostica Group is unifying its commercial sales and marketing regions for the diagnostics portfolio – kits and consumables. Cara Felish will join SSI Diagnostica Group as new head of this commercial division and step into the Global Leadership Team. Cara has extensive experience from the diagnostic, biotech, and pharmaceutical industry in various leadership positions from commercial operation and excellence, sales, and marketing.

“Our main goal is to serve the clinical diagnostic market in the effort of preventing, monitoring, and diagnosing people – supporting better treatment outcomes for patients globally. To accelerate and deliver on our exciting and ambitious growth agenda, we are happy Cara is joining SSI Diagnostica Group to strengthen the global commercial voice of our sales and marketing regions both internally and externally. Our business priorities should be founded on customer needs – and for this we need an aligned global commercial agenda and clear priorities for the global business to accelerate our effort in serving the market with our diagnostic solutions. With Cara’s proven leadership and focus on commercial excellence from both IVD and pharma industry, I am sure this will be a tremendous step in delivering on our priorities.” says Christina Lindved, Group CEO.

SSI Diagnostica Group is owned by Adelis Equity and embarked on a new 5-year strategy and growth plan in 2023 with the introduction of a new Executive and Leadership team. 

As part of our strategic focus on the Vaccine & IVD Industry, we’re delighted to announce new colleagues as part of our commercial team. We proudly welcome two dynamic individuals, each bringing a wealth of experience and passion from the clinical diagnostic industry to our organization:

Stuart McRoberts will be heading the Global Vaccine & IVD Industry Sales Division. Stuart comes with a proven track record as General Manager and Sales Leader in the IVD industry, and he joins us with extensive experience and a strong track record from Thermo Fisher Scientific, Sekisui, Phillips, Abbott, and more. We believe, Stuart’s leadership and industry experience makes him the ideal match to drive and execute our vaccine industry strategy.

Anna Engelund is appointed Head of Strategic Marketing, Reagents. Anna is a professional with a PhD in Neurobiology and an MSc in Biochemistry plus a rich background at Dako, Agilent, and Radiometer. Her expertise will be instrumental in aligning our commercial and portfolio strategy for continued success.

The extensive experience of Stuart and Anna will help us strengthen and accelerate how we commercially execute on serving the Vaccine & IVD Industry segment with our reagent portfolio to deliver on our strong ambition in this area.

SSI Diagnostica Group continues to strengthen the leadership team with the appointment of Finn Albrechtsen as the new Head of Global R&D. Finn has most recently held the CEO position at Vidya Ltd. (VC) as well as VP for R&D and Business Development at Thermo Fisher Scientific Microbiology Division. Prior to that Finn was Snr. Director at Agilent and the Diagnostics & Genomics Portfolio and Project Management Office (PMO). His combined experience within strategy execution, change management across product pipeline is a strong match to the SSID Group.

The fundamental DNA of our company is built on our specialization within Clinical Diagnostics & Surveillance of Infectious Disease for more than 100 years. As a trusted partner to the science community, Finn’s extensive experience within Microbiology and Clinical Diagnostics will help us prioritize and accelerate our R&D pipeline across the Group entities, says the Group CEO Christina Lindved.

The SSID Group has been owned By Adelis Equity Partners since 2016 and in May 2023 a new Chairman and Board of Directors was announced to strengthen the continuous growth journey.

Christina Lindved

CEO, SSI Diagnostica Group