QIAGEN launches QIAstat-Dx in Japan with respiratory panel for syndromic testing
QIAGEN announced that its QIAstat-Dx syndromic testing solution will soon be available in Japan for detecting over 20 respiratory diseases from a single patient sample. This launch follows IVD approval and is expected in mid-2023, pending reimbursement decisions. With over 3,500 QIAstat-Dx instruments installed globally by the end of 2022, the system is designed for easy operation and provides actionable results in about one hour using PCR technology. The QIAstat-Dx platform allows for multiplex real-time PCR testing and unique access to Ct values and amplification curves, aiding clinical decision-making. >QIAstat-Dx connects to the QIAsphere cloud-based platform for remote monitoring, enhancing diagnostic capabilities across hospitals and labs.
- Launch of QIAstat-Dx in Japan enhances revenue potential in a new market.
- More than 3,500 QIAstat-Dx systems installed globally, indicating strong market acceptance.
- The system's unique features (Ct values, amplification curves) may improve clinical decision-making.
- Availability in Japan is contingent on reimbursement level decisions, which may delay market entry.
Japan to become the latest of more than 100 countries where QIAstat-Dx is available for molecular testing in diagnosing over 20 respiratory diseases from one patient sample // Generates actionable results in about one hour based on PCR technology, unique ability to provide Ct values and easy access to amplification curves to support clinical decisions // More than 3,500 QIAstat-Dx instruments installed worldwide at the end of 2022
Venlo, the Netherlands, April 24, 2023 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced today that its QIAstat-Dx syndromic testing solution is expected to be available soon for use in Japan with a SARS-CoV-2 Respiratory Panel that can detect more than 20 pathogens from a single patient sample.
The availability in Japan is expected in mid-2023 after decisions on reimbursement levels and comes as the next step after the recent granting of IVD approval for the test. The entry into Japan will add to more than 100 countries worldwide – including the United States, as well as countries across Europe and other areas of the world – where QIAstat-Dx solutions and various syndromic tests to diagnose diseases are available.
“We are pleased to announce upcoming availability of our QIAstat-Dx SARS-CoV-2 Respiratory Panel in Japan, which enhances our commitment to improving healthcare around the world,” said Jean-Pascal Viola, Senior Vice President and Head of the Molecular Diagnostics Business Area at QIAGEN. “QIAstat-Dx enables easy operation with less labor compared to standard individual PCR assays for each pathogen and provides powerful support for medical workers in respiratory medicine, pediatrics and emergency medicine.”
The system is designed to operate in laboratories and employs cost-efficient, single-use cartridges with all reagents on board and built-in sample processing.
Using multiplex real-time PCR, QIAstat-Dx detects and differentiates between multiple pathogens. QIAstat-Dx is the only syndromic testing system to provide Ct values and easy access to amplification curves. Access to this supplementary data provides additional insight, allowing for better-informed decisions for patients.
With more than 3,500 systems installed worldwide at the end of 2022, QIAstat-Dx is used in hospitals, laboratories and clinics as an easy-to-use solution for reliable diagnosis of various diseases. The first group of panels available are for the detection of respiratory or gastrointestinal pathogens or for distinguishing between meningitis and encephalitis infections.[1]
QIAstat-Dx is available in two formats: The QIAstat-Dx version that brings together up to four Analytical Modules into one integrated system, and the QIAstat-Dx Rise high-capacity version that provides comprehensive testing for up to 160 tests per day using eight Analytical Modules.1
QIAstat-Dx connects to the QIAsphere cloud-based platform that provides remote monitoring of the instruments and test status, allowing customers to receive push notifications on their personal devices. It can monitor an unlimited number of instruments across different hospitals or satellite labs, reducing system downtime and enabling fast and accurate syndromic testing. Connectivity is achieved through the Qbase hub, which can be connected to QIAstat-Dx in minimal time through hospitals’ LAN or Wi-Fi network, ensuring sensitive patient data remains within the hospital network.
QIAsphere also allows users to view and export reports on real-time local, regional and global epidemiology data through QIAsphere Insights to support epidemiological surveillance. Further, with the recent release of a medical reference app for QIAstat-Dx users, the Pathogen Guide, QIAstat-Dx is poised as a leader in digital diagnostic technology for customers around the world.
More information on QIAstat-Dx can be found here: https://www.qiagen.com/us/applications/syndromic-testing
About QIAGEN
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from 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 make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare), Applied Testing (primarily forensics), Pharma (pharma and biotech companies) and Academia (life sciences research). As of December 31, 2022, QIAGEN employed approximately 6,200 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
Forward-Looking Statement
Certain statements contained in this press 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, collaborations markets, strategy or operating results, including without limitation its expected adjusted net sales and adjusted diluted earnings results, 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 management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products to customers in academia, pharma, applied testing and molecular diagnostics; changing 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); our ability to obtain regulatory approval of our products; 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 QIAGEN's new products and the integration of acquired technologies and businesses. 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 (SEC).
Source: QIAGEN N.V.
Category: Corporate
[1] Product availability may differ from country to country based on regulations and approvals.
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