Gram-positive bacteria are a group of bacteria that retain a purple color in a standard lab dye test because they have a relatively thick, rigid outer wall. Investors should care because that structural difference affects how infections are detected, how antibiotics and vaccines work against them, and how biotech or pharmaceutical products are developed, regulated and monitored for safety—much like knowing whether an enemy wears chainmail changes strategy and equipment.
antimicrobial resistancemedical
Antimicrobial resistance is when microbes such as bacteria, viruses or fungi evolve so that medicines meant to kill them no longer work — like a lock changing so the old key no longer fits. For investors, this increases demand and cost for new treatments, prolongs hospital stays, prompts tougher regulation and can shrink sales of once-effective drugs, affecting pharmaceutical revenues, R&D spending and broader healthcare risk.
CE-IVDR-certifiedregulatory
CE-IVDR-certified means a medical diagnostic device has met the European Union’s stricter safety and performance rules for in‑vitro diagnostics and carries the CE mark under the IVDR framework, allowing it to be sold in the EU. For investors, that certification is like a safety inspection sticker on a car: it signals official approval, can increase customer trust, enable access to a major market, and often raises the cost and time required to develop similar competing products.
syndromic testingmedical
A syndromic test is a single diagnostic kit that checks simultaneously for many different germs or conditions that can cause the same set of symptoms, like a multi-tool that looks for all likely culprits at once. For investors, it matters because these tests can shorten time to correct treatment, reduce overall costs, and drive demand for labs and companies that supply faster, consolidated diagnostic solutions — influencing revenue, adoption rates, and reimbursement decisions.
antimicrobial stewardshipmedical
A coordinated program to make sure antibiotics and other infection-fighting drugs are used only when needed, in the right dose and for the right length of time to prevent drug resistance and harm to patients. For investors, stewardship affects demand for certain medicines, hospital costs, regulatory scrutiny, and long-term value of antibiotic pipelines—think of it as traffic rules that reduce crashes and keep the medicine supply effective over time.
Laboratory Developed Tests (LDTs)regulatory
Laboratory developed tests (LDTs) are diagnostic tests created, validated and performed within a single clinical laboratory rather than bought as a finished product from a manufacturer; think of a chef developing a custom recipe in their own kitchen instead of serving a store-bought dish. Investors watch LDTs because they can be a steady source of revenue and competitive advantage for labs, but they also carry regulatory, reimbursement and liability risks that can quickly affect a lab’s earnings and valuation.
molecular testingmedical
Molecular testing analyzes tiny biological markers—like DNA, RNA or specific proteins—to detect diseases, identify pathogens or measure treatment-related changes. Think of it as reading a biological barcode or fingerprint that tells doctors exactly what is happening at the cellular level. For investors, molecular tests matter because they drive demand for diagnostic products, influence clinical trial outcomes and regulatory decisions, and can quickly change revenue and valuation when adopted in clinical care.
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QIAstat-Dx BCID GPF Plus AMR Panel detects gram-positive bacteria, fungi and key antimicrobial resistance markers from positive blood cultures and colonies
CE-IVDR-certified panel identifies 20 pathogens and 10 resistance targets in about one hour to enable faster clinical decision-making
Launch marks QIAGEN’s expansion into bloodstream infection syndromic testing, building on earlier panels for respiratory, gastrointestinal and meningitis / encephalitis testing
HILDEN, Germany & VENLO, Netherlands--(BUSINESS WIRE)--
QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced its expansion into syndromic testing for bloodstream infections with the launch of the CE-IVDR-certified QIAstat-Dx BCID GPF Plus AMR Panel.
The launch of this new QIAstat-Dx panel coincides with the ESCMID Global 2026 Congress in Munich (April 17–21), where QIAGEN will highlight its broad infectious disease portfolio, including QIAstat-Dx, the QuantiFERON-TB Gold Plus test for tuberculosis detection, alongside additional technologies supporting laboratory workflows, clinical decision-making and the development of Laboratory Developed Tests (LDTs).
The QIAstat-Dx BCID GPF Plus AMR Panel enables laboratories to identify 20 gram-positive bacterial and fungal pathogen targets (GPF) and 10 antimicrobial resistance (AMR) markers from positive blood cultures and pure colonies. This launch expands the QIAstat-Dx portfolio beyond respiratory, gastrointestinal and meningitis / encephalitis testing into bloodstream infection applications.
In bloodstream infections, timely identification of pathogens and resistance markers is critical, as treatment decisions often need to be made quickly. By delivering results in about one hour, the QIAstat-Dx BCID GPF Plus AMR Panel is designed to support laboratory workflows while providing clinically relevant information for patient management, antimicrobial stewardship and infection control efforts.
“Rapid identification of pathogens and resistance markers is important in bloodstream infections, where treatment decisions often need to be made quickly,” said Nadia Aelbrecht, Vice President, Head of Infectious Diseases at QIAGEN. “With this launch, we are extending the QIAstat-Dx portfolio into bloodstream infection testing and giving laboratories a new option to generate clinically relevant results from positive blood cultures and colonies. We plan to further expand this offering with additional panels in development, including those targeting gram-negative pathogens.”
QIAstat-Dx integrates sample preparation, molecular testing and data analysis into a single workflow. The systems are available in more than 100 countries, with more than 5,200 instruments placed worldwide as of the end of 2025.
QIAGEN N.V., a Netherlands-based holding company, is a global leader in Sample to Insight solutions that enable customers to extract and analyze molecular information from biological samples containing the building blocks of life. Our Sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies prepare these biomolecules for analysis, while bioinformatics support the interpretation of complex data to deliver actionable insights. Automation solutions integrate these steps into streamlined, cost-effective workflows. QIAGEN serves more than 500,000 customers worldwide in the Life Sciences (academia, pharmaceutical R&D and industrial applications such as forensics) and Molecular Diagnostics (clinical healthcare). As of December 31, 2025, QIAGEN employed approximately 5,700 people across more than 35 locations. For more information, visit www.qiagen.com.
Forward-Looking Statement
Certain statements contained in this release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN’s products, timing for launch and development, marketing and/or regulatory approvals, financial and operational outlook, growth and expansion, acquisitions, collaborations, markets, strategy or operating results, including without limitation its expected net sales, net sales of particular products, net sales in particular geographies, adjusted net sales, expansion of adjusted operating income margin, returns to shareholders, progressive dividend payments, product portfolio management, product launches, leveraging AI technology, improvements in operating and financial leverage, currency movements against the U.S. dollar, plans for investment in our portfolio and share repurchase commitments, our expectations relating to our adjusted tax rate, debt maturity and repayment, our ability to grow adjusted earnings per share at a greater rate than sales, our ability to improve operating efficiencies and maintain disciplined capital allocation, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with our dependence on the development and success of new products; management of growth and expansion of operations (including the effects of currency fluctuations, tariffs, tax laws, regulatory processes and logistics and supply chain dependencies); variability of operating results; integration of acquired businesses; changes in relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN’s products (including fluctuations due to general economic conditions, the level and timing of customers’ funding, budgets and other factors, including delays or limits in the amount of reimbursement approvals or public health funding); our ability to obtain and maintain product regulatory approvals; difficulties in successfully adapting QIAGEN’s products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors’ products; market acceptance of new products and the integration of acquired technologies and businesses; actions of governments, global or regional economic developments, including inflation and changing interest rates, weather or transportation delays, natural disasters, cyber security breaches, political or public health crises, and the resulting impact on the demand for our products and other aspects of our business, or other force majeure events; litigation risk, including patent litigation and product liability; debt service obligations; volatility in the public trading price of our common shares; as well as the possibility that expected benefits related to recent or pending acquisitions may not materialize as expected; and the other factors discussed under the heading “Risk Factors” in our most recent Annual Report on Form 20-F. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission.
