SSI Diagnostica

Copenhagen, 3 February 2026 SSI Diagnostica Group, a global company specializing in testing solutions for infectious diseases, has announced the acquisition of InDevR, a Colorado-based provider of advanced multiplexed solutions for vaccine testing and quality control. The addition strengthens SSID Group’s leadership in pneumococcal vaccine QC testing with next-generation multiplexing assays and enhanced customization capabilities. InDevR will advance the Group’s offering by adding recognized expertise in influenza and mRNA vaccine QC testing. Overall, the acquisition is a natural continuation of SSI Diagnostica Group’s M&A strategy to expand its global footprint and portfolio offerings. SSI Diagnostica Group has two complementary portfolios with both Life Science and In Vitro Diagnostics . The company serves three main application areas: vaccine development, disease surveillance, and diagnostic testing. Targeted acquisitions driving portfolio expansion Earlier in 2025, SSID Group expanded its In Vitro Diagnostics offering through the acquisition of Gulf Coast Scientific, adding urea breath testing to an already established testing portfolio for H. pylori. This allowed SSID Group to increase its ability to meet changing and diverse clinical needs. With the acquisition of InDevR, SSID Group now accelerates growth of the Life Science Solution segment. “ Today, vaccine developers face an increasingly complex landscape, as new disease variants emerge and multiplexing becomes more important. By combining our existing leadership in vaccine testing with InDevR’s closed multiplexing system and its analytical software capabilities, we are well-positioned to address emerging needs, helping our customers scale and future-proof their vaccine pipelines ”, says Christina Lindved, CEO of SSI Diagnostica Group. Accelerating the global impact Kathy Rowlen, CEO of InDevR adds: “ From our earliest discussions, it was clear that SSID Group was an excellent fit to advance what we have built and to provide comprehensive support for our global biopharma customers. Becoming part of the company enables us to accelerate our impact so that we, together, can bring a powerful, integrated portfolio to the global vaccine and surveillance markets ”. InDevR’s expertise in multiplexing aligns closely with SSID Group’s strategy to offer end-to-end solutions in both Life Science and In Vitro Diagnostics. “ We remain committed to scaling SSID Group to meet evolving demands of our customers ”, says Nachum (Homi) Shamir, Chairman of the board in SSID Group, who continues: “ Both organic growth and targeted acquisitions will continue to be important levers as we strengthen our global position as a leading infectious disease partner ”. Adding InDevR’s multiplexing technology, expertise in influenza vaccines, and engineering innovation serves SSID Group’s company mission: Empowering healthcare professionals to prevent, monitor, and diagnose infectious diseases, and enabling better treatment outcomes for patients. About SSI Diagnostica Group: SSID Group is a global company with ~600 employees, specializing in infectious disease solutions for gastrointestinal, respiratory, and bloodborne diseases. With its two complementary portfolios in Life Science and In Vitro Diagnostics, the company serves three main application areas: vaccine development, disease surveillance, and diagnostic testing. SSID Group has scientific roots dating back to the early 1900s. The Group employ staff and operate offices in Denmark, the United States, and China, ensuring proximity to their customers and patients across all continents. About InDevR: InDevR is a global leader in progressive new analytical technologies that enable accelerated development and manufacturing of vaccines and other biotherapeutics. Key products include the VaxArray® Portfolio of game-changing multiplexed potency assays for vaccines and the CypherOne System for digital imaging and automated interpretation of hemagglutination assays. For further information or interview requests please contact: Mathias Skovsted, Strategy Manager, SSI Diagnostica Group +45 41714853, mathias.skovsted@ssid.com

NEW YORK--(BUSINESS WIRE)--Carl Marks Securities, an affiliate of middle market investment bank Carl Marks Advisors, announced that it has successfully advised Gulf Coast Scientific (“Gulf Coast” or the “Company”), an industry-leading developer, manufacturer, and distributor of cost effective, non-invasive diagnostic medical tests, on its sale to SSI Diagnostica Group (“SSID”), a global leading developer and manufacturer of specialized infectious disease diagnostic solutions. Founded over 25 years ago and headquartered in Oldsmar, Florida, Gulf Coast’s primary product is an FDA-approved urea breath test with an accuracy rate of over 99% and a rapid result. This test is recognized as the most accurate, cost-effective, and easy-to-use solution in the international H. pylori diagnostics market, with Gulf Coast currently doing business in 27 countries. Customers include laboratories, hospitals, doctors’ offices, surgery centers, and distributors. Gulf Coast is also in late-stage clinical development of pulmonary-based breath tests for diagnosing and monitoring pneumonia, cystic fibrosis, and other conditions. Since H. pylori was only recently discovered in the early 1980s, there remains a lack of awareness about the infection among both the general public and the medical community, and its link to certain illnesses and gastrointestinal cancer. Over 60 million people in the U.S. suffer from ongoing H. pylori infections and approximately double that number have symptoms associated with it yet remain undiagnosed. This acquisition increases the Company’s visibility and expands its domestic and international presence. 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. “In the year that we have been working with them, our team has seen Gulf Coast continue to increase its market penetration and is delighted to have successfully guided them through their acquisition by SSI Diagnostica Group,” said Warren H. Feder, Partner at Carl Marks Advisors. “With both companies specializing in H. pylori diagnostics and producing complementary products, the combination makes sense for everyone involved. Together, these companies will be able to generate greater awareness of H. pylori and offer a range of testing options to health care professionals internationally.” “The Carl Marks team, including Warren Feder, Michael Gordon, and Alan Gutman, brought a truly personalized approach, and what started as a business relationship became one of true friendship. We placed our full trust in their advice and guidance, which ultimately led us to a very successful closing with a perfect partner,” said Philip Ross, Chief Executive Officer of Gulf Coast Scientific. “We are thrilled to join forces with SSID to bring innovative testing solutions that improve patient outcomes to more customers. We look forward to benefiting from the synergies of our products and distribution networks as we expand upon our global capabilities.” “We are excited for the Gulf Coast team to become part of the SSID family. The Company’s innovative tests are industry-leading and complement our offerings nicely,” said Christina Lindved, Chief Executive Officer of SSI Diagnostica Group. “Philip and his team, whose leadership and strong relationships with quality labs and hospital systems around the world have been a huge part in the Company’s success, will join our management team and continue to lead Gulf Coast. We look forward to embarking on this journey together as we help serve even more patients with gastric infections.” About Carl Marks Securities Carl Marks Securities LLC, the broker-dealer affiliate of Carl Marks Advisory Group LLC (Carl Marks Advisors), provides financial advisory services to middle market companies, including advice related to mergers, acquisitions, company sales, private placement of debt and equity capital and financial restructurings. Carl Marks Securities LLC is a member of FINRA and SIPC. Additional information about Carl Marks Securities LLC can be found at www.carlmarkssecurities.com. 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. 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.

None   Welcome to this week's Chutes & Ladders, our roundup of hirings, firings and retirings throughout the industry. Please send the good word—or the bad—from your shop to Max Bayer or Gabrielle Masson, and we will feature it here at the end of each week.  New North American diagnostics head is latest in Roche’s string of CEO appointments Roche Diagnostics  Roche Diagnostics tapped Brad Moore to lead the testmaker’s North American division as CEO. Moore, who’s currently senior VP of the core lab and point of care unit within the division, has been at Roche since 2016 when he originally came aboard as head of its diabetes division in North America. Before that, he put in almost two decades at Johnson & Johnson, including stints within the DePuy Spine device division and the Canadian business of diabetes monitoring subsidiary LifeScan, as well as two years spent as vice president of health system innovation at J&J proper. Moore’s appointment is the culmination of a domino effect of new hires that began over the summer, when Roche plucked its next CEO, Thomas Schinecker, Ph.D., from the top of its diagnostics pyramid. Replacing Schinecker as CEO of the worldwide Roche Diagnostics business, meanwhile, is Matt Sause, who in turn will vacate the spot that’s now set to be filled by Moore. Both Sause and Moore are slated to step into their new roles Jan. 1, while Schinecker will take the helm of the Big Pharma on March 15. Fierce Biotech Amgen vet heads over to helm newly emerged biotech Dantari Ex-Amgen veteran Richard Markus, M.D., Ph.D., left the world of Big Pharma to guide newly emerged biotech Dantari. Before stepping up as the biotech’s president and CEO, Markus served as Amgen’s VP of global development for 13 years, exiting in 2019 to head up Dantari. The leader has also held past roles at Corus Pharma (acquired by Gilead) and Allecure (acquired by Mannkind).  Markus now helms the Los Angeles biotech, which debuted this week with $47 million in hand and platform technology spun out from the California Institute of Technology. Release Kriwet leaves Fresenius Medical Care after just 2 months as CEO Fresenius Medical Care Just nine weeks into her tenure as chief executive of Fresenius Medical Care, Carla Kriwet, Ph.D., has already stepped down. The German dialysis giant cited “strategic differences” for the split in a Dec. 5 announcement, noting that Kriwet was leaving “at her own request and by mutual agreement.” She was replaced the following day by Helen Giza, who was originally hired in 2019 as Fresenius’ CFO. In the years since, she’s added the roles of chief transformation officer and deputy CEO to her job duties. As CEO, she’ll continue on as acting CFO until the company can find a suitable replacement for that position. Fierce Biotech > After six years with the company, Agios Pharmaceuticals Chief Commercial Officer Richa Poddar plans to step down, with Tsveta Milanova set to fill the role Jan. 3. Milanova joins from AstraZeneca’s rare disease arm Alexion, where she most recently served as SVP and head of the U.S. commercial unit. Before that, Milanova logged more than 10 years of experience at Celgene. Release > Syndax Pharmaceuticals, a Massachusetts biotech touting a clinical-stage oncology pipeline, has tapped Steve Sabus to serve as chief commercial officer. Most recently, Sabus served as CCO for Turning Point Therapeutics before it was acquired by Bristol Myers Squibb this summer. He has also held senior roles at Astellas Pharma, where he worked for more than 15 years. Release > Two new execs are joining LifeMine Therapeutics, a Massachusetts biotech refashioning drug discovery by mining genetically encoded small molecules. Elliot Ehrich, M.D., will serve as chief medical officer and EVP of translational science, while Lata Jayaraman, Ph.D., is coming on as EVP and head of biology. Ehrich most recently served as president for Skyhawk Therapeutics, while Jayaraman comes from Bristol Myers Squibb, where she most recently served as head of oncology drug discovery at the Mechanisms of Cancer Resistance Thematic Research Center. Release > Entact Bio has launched with $81 million and Victoria Richon at the helm. Richon has more than two decades of relevant experience most recently serving as founding president and CEO of Ribon Therapeutics. Release > Diego Cadavid, M.D., is joining Verge Genomics as the clinical-stage biotech’s first chief medical officer. Cadavid previously held the same role at X4 Pharmaceuticals, was the SVP of clinical development at Fulcrum Therapeutics and worked for nine years at Biogen. Release > Worldwide Clinical Trials has named Pete Duprat to head its growing early-phase business unit. Duprat joins from NuvoAir, where he was VP of business development. Before NuvoAir, he held senior business development positions at Optum, PPD, ePharma Solutions and Quorum Review. Fierce Biotech > Karuna Therapeutics is shaking up its leadership team, with current President, CEO and Chair Steve Paul, M.D., set to transition to president of R&D and chief scientific officer on Jan. 3. Bill Meury will succeed Paul as president and CEO, while Karuna’s lead independent director Christopher Coughlin will step in as chair of the board. New CEO Meury most recently served as a partner at Hildred Capital Management and has also held several leadership roles at Allergen, such as EVP and chief commercial officer. Release > T-cell regulator Abata Therapeutics has tapped Ellen Cahir-McFarland, Ph.D., to serve as its chief scientific officer, taking the reins from interim CSO Andrea Van Elsas. Cahir-McFarland most recently served as Annexon Biosciences’s SVP of research, and previously held several roles of increasing responsibility at Biogen Discovery Research. Release > Relief Therapeutics has found a new CEO in Jack Weinstein, who’s served as the Swiss drugmaker’s U.S.-based chief financial officer and treasurer since the fall of 2020. He’ll be replaced as CFO by Jeremy Meinen, who arrived at Relief in April 2020 as its ad interim financial chief. Release > LimFlow, which has developed a minimally invasive system for the treatment of chronic limb-threatening ischemia, named Mike Mathias as its new VP of commercial operations. Mathias spent the first decade of his career in sales at Pfizer, then dedicated the next two decades to Medtronic, a stint that culminated in his position as VP of U.S. commercial operations for the medtech’s structural heart business. Release > Hoping to build out its stateside presence, Irish cell therapy company ONK Therapeutics has appointed a new chief scientific officer based in the U.S. Bruce McCreedy, Ph.D.—an immunologist and cell and gene therapy expert who hails from Myeloid Therapeutics—will replace Michael O’Dwyer, M.D., who was also the scientific founder of ONK. O’Dwyer is transitioning to a full-time role as a professor of hematology at the University of Galway but will remain a board member and scientific adviser to the biotech. Release > Nis Kruse has joined Danish diagnostics maker BioPorto as executive VP of strategic partnerships and general manager of the company’s Asia-Pacific and Europe, Middle East and Africa divisions. He brings nearly two decades of experience in biopharma and medtech, including at SSI Diagnostica, Merck, Agilent Technologies and AstraZeneca. Release > Ligand Pharmaceuticals CEO John Higgins is retiring after 16 years at the helm of the drug developer. As of Dec. 5, he’s been replaced by Todd Davis, a member of Ligand’s board of directors and managing partner and founder of RoyaltyRx Capital. Higgins will also resign as a director of Ligand’s board Dec. 31, though he’ll continue on as chairman of spinout company OmniAb. Release > On its mission to build out a portfolio of CRISPR-based therapeutics, diagnostics and more, Mammoth Biosciences has found a new chief business officer: Phil Tinmouth. Before joining the San Francisco-based company, he spent almost 20 years at Vertex Pharmaceuticals and, most recently, worked as chief business and strategy officer of Pardes Biosciences. Release