List of Diagnostics Companies in Sweden - 21

The commercially available Stockholm3- test, is a blood-test for early detection of prostate cancer. A3P Biomedical’s Stockholm3 test, combines protein markers, genetic markers and clinical data with an advanced algorithm in order to detect aggressive prostate cancer at early stage.

Acarix is a Swedish medical device company that innovates solutions for rapid Coronary Artery Disease (CAD) rule-out. The CE-mark approved and FDA De Novo cleared Acarix CADScor®System is for patients experiencing chest pain with suspected CAD and is designed to help reduce millions of unnecessary, invasive, costly diagnostic procedures. CADScor®System rapidly calculates a patient-specific CAD-score non-invasively with 96% confidence. Acarix is listed on the Nasdaq First North Premier Growth Market (ticker: ACARIX).

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Ascelia Pharma is a biotech company focused on orphan oncology treatments. We develop and commercialize novel drugs that address unmet medical needs and have a clear development and market pathway. The company has two drug candidates – Orviglance® (former working name Mangoral) and Oncoral – in clinical development. Ascelia Pharma has global headquarters in Malmö, Sweden, and is listed on Nasdaq Stockholm (ticker: ACE). About Orviglance (Mangoral) Orviglance* (manganese chloride tetrahydrate) is a novel oral contrast agent for MR-imaging developed to improve the detection and visualization of focal liver lesions (including liver metastases and primary tumors) in patients with reduced kidney function. These patients are at risk of serious side effects from the currently available class of gadolinium-based contrast agents. Orviglance, which has been granted an Orphan Drug Designation by the US Food and Drug Administration (FDA), is currently in Phase 3 development, including the global multi-center SPARKLE study. About Oncoral Oncoral is a novel oral irinotecan tablet in development. Irinotecan is a chemotherapy with established potent anti-tumor effect – even in difficult to treat cancers. Oncoral is a daily tablet with the potential to offer better patient outcomes with improved safety following a daily tablet treatment compared to intravenous high-dose infusions at the hospital. Oncoral is initially developed for the treatment of gastric cancer, a cancer form with unmet needs and the opportunity for Orphan Drug status in the US and Europe. Following successful Phase 1 results, Phase 2 clinical development for Oncoral is in preparation. *Trademark is registered in Europe and several other markets and submitted for registration in the US.

Biovica develops and commercializes blood-based biomarker assays that improve the monitoring of modern cancer therapies and predict patient outcomes. The company’s DiviTum™ TKa assay, a test for accurately measuring cell proliferation, has successfully demonstrated its capabilities to early evaluate therapy effectiveness in several clinical trials. Biovica aims to make best-possible-treatment from day one a reality. Biovica collaborates with world-leading cancer institutes as well as pharmaceutical companies launching next-generation therapies. The company is ISO 13485 certified for Quality Management Systems. DiviTum™ is CE-labeled and MPA-registered.

Carbiotix is an award-winning biotechnology company pioneering the onsite upcycling of plant-based side-streams. Carbiotix mission is to improve the health of people by increasing the consumption of prebiotics and other active ingredients from upcycled side-streams. Carbiotix offers one core service today called NutraCycle, an on-site upcycling and fortification service allowing food & beverage, ingredient, and feed producers to turn plant-based products into healthier, more profitable, and sustainable products.

Diaprost is a private pharmaceutical research and development company based in Lund, Sweden. The company's principal asset is hu5A10, a novel Theranostic Antibody licensed for development in the treatment and diagnosis of prostate cancer. Diaprost has also announced promising new studies for patients with metastatic prostate cancer, and has entered into license agreements with other companies for the development of its products.

Elypta is a Swedish molecular diagnostics company focused on reducing cancer mortality through early detection. Elypta is pioneering a metabolism-based liquid biopsy and measures the GAGome – system biomarkers of tumor metabolism. Machine learning algorithms are then used to detect signatures of cancer noninvasively. Elypta is advancing a broad clinical program across different cancers with the first indication expected to be early detection of recurrence in renal cell carcinoma. Several years of research in Nielsen lab at Chalmers University of Technology in Gothenburg, Sweden led to the founding of Elypta in May 2017 by Francesco Gatto and Jens Nielsen.

Epigenica is a life sciences technology company at the forefront of innovations in epigenetic research. The company's EpiFinder platform enables researchers to perform comprehensive epigenetic studies at unprecedented speed, scalability, and affordability. Epigenica is building a portfolio of products based on the EpiFinder platform to offer comprehensive high-throughput profiling at different depths of detail with an array of possible starting materials. The platform is powered by the company's patented and proprietary high-throughput, multiplex, quantitative ChIP-seq technology (hmqChIP), the first commercial kit of its kind. With the advantages of the EpiFinder platform, Epigenica is helping researchers advance biomedical research, drug discovery and development, precision medicine, diagnostics, and therapeutics for aging and longevity.

Gradientech is a Swedish in vitro diagnostics company that supports the modern microbiology lab with cutting-edge solutions to facilitate the workflow with time-critical samples. Our product, QuickMIC®, is an ultra-rapid system for antibiotic susceptibility testing (AST) of positive blood culture samples from sepsis patients. QuickMIC® is a scalable system with each instrument analysing one sample against a tailored gram-negative antibiotic panel. MIC values are reported in as short as 2 hours, making it more rapid than any other diagnostic system for phenotypic AST. Gradientech's technology combines microfluidics with live imaging to analyse bacterial responses on a linear antibiotic concentration gradient. The revolutionary technology delivers MIC values with unprecedented precision in record time.

Hansa Biopharma, is a pioneering commercial-stage biopharmaceutical company on a mission to develop and commercialize innovative and life altering treatments for patients with rare immunological conditions. Hansa scientists are working on developing immunomodulatory treatments for organ transplants, rare IgG-mediated autoimmune conditions, and gene therapy, as well as exploring the potential application of the technology platform in oncology.

Immunovia AB is a diagnostic company that is developing and commercializing highly accurate blood tests for the early detection of cancer and autoimmune diseases based on Immunovia’s proprietary test platform called IMMray™. Tests are based on antibody biomarker microarray analysis using advanced machine-learning and bioinformatics to single-out a set of relevant biomarkers that indicate a certain disease. Thus, forming a unique “disease biomarker signature”. The company was founded in 2007, based on cancer studies and ground-breaking research in the Department of Immuntechnology at Lund University and CREATE Health Cancer Center, Sweden. The first product, IMMray™ PanCan-d, is undergoing clinical evaluation in some of the world’s largest clinical studies for high risk groups in pancreatic cancer, PanFAM-1, PanSYM-1 and PanDIA-1. In 2017, Immunovia, Inc. was established in Marlborough, Massachusetts, USA. The IMMray™ PanCan-d test, the first blood-based test dedicated to the early detection of pancreatic cancer on the market, is offered as a laboratory developed test (LDT) exclusively through Immunovia, Inc. For more information see: www.immunoviainc.com. Immunovia’s shares (IMMNOV) are listed on Nasdaq Stockholm. For more information, please visit www.immunovia.com.

We specialise in medical technology for digital pathology and aim to improve tissue diagnostics with our patented technology. With technology based on up-converted nanoparticles (UCNP), high-quality images are generated with increased contrast and decreased irrelevant background noise. These images shorten turnaround time and provide higher-quality data for analysis. Lumito is a spin-off from a research team at Lund University's Division of Atomic Physics and Laser Centre and is planning to launch its product SCIZYS for research laboratories initially.

Pelago Bioscience AB is founded to accelerate the use and value of the CETSA® technology in Drug Discovery and diagnostics. We know that the need for Target Engagement studies is large and increasing and there is no single technology with the same opportunities to fill this need as CETSA®. We will: - Make more relevant data available to our customers at an earlier stage of the Drug Discovery process - Enable filtering of compounds based on physiologically relevant data to facilitate better decisions in Drug Discovery programs - Provide our customers with CETSA® based Target Engagement data in vitro and in vivo - Improve translation from laboratory to patient by using a single technology - CETSA® - Facilitate development of novel medicine in clinical trials using CETSA® - Develop diagnostic kits, companion diagnostics and tools for monitoring Target Engagement during patient treatment using CETSA® Pelago Bioscience AB will by these accomplishments add value to Drug Discovery programs allowing for faster and better development of new and improved drugs. By developing the CETSA® technology for general clinical use as a diagnostic and treatment monitoring tool we aspire to improve the lives and health of patients.

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Perimed AB is a Swedish company, founded in 1981 and headquartered just outside Stockholm. Perimed develops, manufactures and markets state-of-the-art diagnostic equipment to assess microcirculation and peripheral perfusion as well as Peripheral Arterial Disease. We offer solutions for clinical use as well as for research. We have more than 40 years of experience and unique competence in fiber optics, laser and camera optics, as well as tissue optics making Perimed a leader in measuring and assessing microcirculation and peripheral macro circulation. Perimed is a global company with subsidiaries in USA, China, France, Italy and Germany. Our customers in the other countries are supported either directly from our Swedish headquarters or by our certified local distributors listed on our contacts pages.

Rarity Bioscience provides ultra-sensitive multiplex assays for mutation detection in blood and other liquid biopsies for research, pharma and labs. The superRCA technology is based on padlock probes and rolling circle amplification, enabling extreme sensitivity and specificity, and utilize well established high throughput flow cytometry for the read-out. The company was founded in 2021 based on a discovery by Dr Lei Chen, PhD in molecular biology, and a member of Professor Ulf Landegrens team at the Department of Immunology, Genomics and Pathology at Uppsala University.

SAGA Diagnostics is a personalised cancer medicine and disease monitoring company focused on molecular genetic analyses of circulating tumor DNA and tissue biopsies.

SciBase is a global medical technology company, specializing in early detection and prevention in dermatology. SciBase develops and commercializes Nevisense, a unique point-of-care platform that combines AI (artificial intelligence) and advanced EIS technology to elevate diagnostic accuracy, ensuring proactive skin health management. Our commitment is to minimize patient suffering, allowing clinicians to improve and save lives through timely detection and intervention and reduce healthcare costs. Built on more than 20 years of research at Karolinska Institute in Stockholm, Sweden, SciBase is a leader in dermatological advancements. The company has been on the Nasdaq First North Growth Market exchange since June 2, 2015. Learn more at www.scibase.com

For customers working in the life sciences and pharma industry, Svar offers a unique combination of scientific expertise, high-quality assay products, strong services, and proprietary technology platforms that provide a flexible, effective, and seamless experience for customers through different development needs in a way that no other single business can. At Svar, we are dedicated to our customers' development journey. We harness a deep understanding and long-standing experience in immunological areas such as complement system activation and immunogenicity. We utilize this in our expert cell engineering, assay development, and contract research services capabilities. Our specialist knowledge allows us to help you tackle complex problems, safely and efficiently moving your candidates through the drug development phases and to the patient—also when standard solutions fall short.

Xintela develops medical products in stem cell therapy and targeted cancer therapy based on the Company's cell surface marker integrin α10β1 which is found on mesenchymal stem cells and on certain aggressive cancer cells. The stem cell marker is used to select and quality-assure the patent-protected stem cell product XSTEM®, which is in clinical development for treatment of knee osteoarthritis and difficult-to-heal leg ulcers. The company produces XSTEM for the clinical studies in its GMP-approved manufacturing facility. In cancer therapy, which is run by the wholly owned subsidiary Targinta AB, therapeutic antibodies, targeting integrin α10β1 (First-in-Class) are being developed for the treatment of triple-negative breast cancer and the brain tumor glioblastoma.