QIAGEN receives FDA clearance for QIAstat-Dx respiratory syndromic testing panel for fast and accurate results

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced a decision to discontinue the NeuMoDx 96 and 288 Molecular Systems in light of the market development trends for these product lines following the COVID-19 pandemic and changing customer needs for integrated PCR-based clinical molecular testing systems.

This decision will allow QIAGEN to refocus resources and efforts on developing and commercializing other innovative solutions within its portfolio, in particular the QIAstat-Dx system for syndromic testing, the QIAcuity portfolio of digital PCR systems and the QIAGEN Digital Insights (QDI) bioinformatics business. These are complemented by QIAGEN building on proven leadership positions in Sample technologies and the QuantiFERON-TB franchise.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of its new digital PCR (dPCR) Custom Assay Design Tool for copy number variation (CNV) analysis for use on its digital PCR platform QIAcuity and several other enhancements in its GeneGlobe Design and Analysis Hub, a comprehensive research platform that integrates pre-designed assays with a database of more than 10,000 biological entities including genes, miRNAs, and pathways. The new advancements aim to support customers with a wide range of assay customization options, from simple to complex and validated multiplex assays, while further improving the user experience.

Genetic research is moving fast, and new target genes are rapidly evolving that are not covered by standard or pre-designed assays. To keep pace and close the need gap, the new digital PCR Custom Assay Design Tool has been developed as an interface on the GeneGlobe platform. It enables customers to design and order assays for use on QIAGEN's digital PCR platform QIAcuity outside of QIAGEN's comprehensive catalog of over 200 wet-lab validated assays for copy number variations profiling in translational cancer research. Copy number variations (CNVs) are a type of genetic variation where specific segments of the DNA are copied more or fewer times than normal in the genome, potentially affecting susceptibility to diseases and response to treatment.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of the QIAstat-Dx Gastrointestinal Panel 2 in the United States. The launch comes after the recent clearance of the syndromic test for clinical use by the U.S. Food and Drug Administration (FDA) and marks a significant step forward in improving the accuracy and efficiency of gastrointestinal (GI) infection diagnosis.

The QIAstat-Dx Gastrointestinal Panel 2 takes about an hour to simultaneously look for up to 16 clinically relevant bacterial, viral and parasitic pathogens that cause most GI infections. Acute infectious gastroenteritis is a common reason for hospitalizations and outpatient physician visits in the U.S., with an estimated 180 million cases per year. [1]

The panel leverages QIAstat-Dx's ability to quickly multiply many genetic targets using real-time PCR technology in the same reaction – an important advance compared to traditional microbiological testing, which often requires samples to be incubated for at least 24 hours and up to 10 days of specimen collection. Software interprets signals from the reaction and provides positive or negative results for each pathogen. QIAstat-Dx additionally provides easy-to-view cycle threshold (Ct) values and amplification curves that can offer additional insights not available with end-point PCR or other techniques.

"The QIAstat-Dx Gastrointestinal Panel 2 allows medical professionals to identify which GI pathogen they are dealing with quickly," said Fernando Beils, Senior Vice President and Head of the Molecular Diagnostics Business Area at QIAGEN. "This is QIAGEN's answer to two major problems in treating GI infections: diagnosis of overlapping symptoms and laborious testing methods."

"It can be very difficult to clinically distinguish between viral, bacterial and parasitic causes of GI illness. We can easily set up and get a full panel of results back faster than culture and microscopy, and access to Ct values for each detected pathogen can provide valuable information when interpreting when interpreting multiple pathogen detections," added Romney Humphries, Ph.D., professor of Pathology, Microbiology, and Immunology and division director for Laboratory Medicine at Vanderbilt University Medical Center in the U.S. about the clinical utility of QIAstat-Dx.

The new panel expands QIAGEN's U.S. menu for syndromic testing, building on the use of the QIAstat-Dx Respiratory Panel Plus that can identify 21 pathogens causing respiratory infections from viral and bacterial pathogens. Both Panels are available as cost-efficient, single-use cartridges that slot easily into the QIAstat-Dx Analyzer 1.0. As they contain all reagents, set up takes less than a minute and requires no precision pipetting.

The U.S. launch supports healthcare providers with diagnosing and treating patients quickly and accurately. They will be able to quickly isolate those at risk of transmitting infections and identify negative cases sooner, reducing the burden of unnecessary testing and treatment costs on the healthcare system and patients. Syndromic tests have also been shown to improve the detection of co-infections, reducing the need for additional testing like endoscopies. By providing fast results, syndromic testing enables healthcare providers to make informed decisions and discontinue empiric antibiotic treatment when viral pathogens are detected, reducing overall antibiotic usage and supporting the goal of responsible antimicrobial stewardship.

Syndromic testing with cloud-based connectivity and epidemiological insights

QIAstat-Dx solutions and syndromic tests to support diagnosing diseases are available in more than 100 countries worldwide, including the U.S. and many across Europe. More than 4,000 cumulative systems were installed worldwide at the end of 2023. Hospitals, laboratories and clinics value the QIAstat-Dx range as an easy-to-use automated solution for the reliable detection of various pathogens.

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 higher-capacity version that provides comprehensive testing for up to 160 tests per day using eight Analytical Modules. QIAstat-Dx Rise is available with CE-IVD marking in Europe and other countries that accept this marking.

With a QIAstat-Dx Connectivity plan, 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.

Learn more about QIAstat-Dx and the Gastrointestinal Panel 2 at https://www.qiagen.com/applications/syndromic-testing/benefits/gastrointestinal-care

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) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of March 31, 2024, QIAGEN employed approximately 5,900 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, including those products used in the response to the COVID-19 pandemic, timing for launch and development, marketing and/or regulatory approvals, financial and operational outlook, growth and expansion, 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; actions of governments, global or regional economic developments, weather or transportation delays, natural disasters, political or public health crises, including the breadth and duration of the COVID-19 pandemic and its impact on the demand for our products and other aspects of our business, or other force majeure events; 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" contained in Item 3 of 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.

Source: Qiagen N.V.
Category: Corporate

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) and Myriad Genetics (NASDAQ: MYGN) today announced they will develop a globally distributable kit-based test for analyzing Homologous Recombination Deficiency (HRD) status. This next-generation sequencing (NGS) test aims to support research into personalized medicine in multiple solid tumor types, including ovarian cancer and is expected to enhance decentralized testing capacities once a regulated product is developed with pharmaceutical partners. The project builds on the recently announced master collaboration agreement between the two companies.

The test will be based on QIAGEN's QIAseq xHYB technology, QIAGEN Digital Insight solutions, which creates a sample to insight HRD solutions, and Myriad's proprietary FDA-approved MyChoice CDx, a single-site PMA-approved centralized testing service for analyzing HRD in certain tumors. MyChoice CDx assesses the HRD status by examining a tumor's DNA repair capabilities, particularly focusing on BRCA1 and BRCA2 gene mutations and calculating a Genome Instability Score (GIS). The GIS aids in pinpointing ovarian cancer patients who are most likely to benefit from targeted treatments, such as LYNPARZA® (olaparib) by AstraZeneca.

"Our partnership with Myriad Genetics underscores a shared commitment to advancing cancer diagnostics. Together, we aim to broaden the accessibility of HRD tests, allowing an increasing number of cancer patients to benefit from tailored treatments," said Fernando Beils, Senior Vice President and head of the Molecular Diagnostics Business Area. "By introducing a distributable HRD test, we anticipate a reduction in the time required for therapy decisions, a decrease in associated costs, and shorter turnaround times compared to outsourced testing, ultimately benefitting the patients."

The MyChoice CDx assay can identify 34% more tumors with HRD using the GIS score compared to other methods only using percent loss of heterozygosity (%LOH) [1] . Given that approximately 48% of ovarian cancer tumors exhibit HRD [2] , often due to specific mutations within the tumor, expanding access to this assay is vital for advancing personalized medicine and ensuring that patients receive the most appropriate treatments.

We're excited to share this milestone in our partnership with QIAGEN as we work collectively to advance cancer care worldwide," said Patrick Burke, Executive Vice President of Strategy and Innovation, Myriad Genetics. "By extending the global reach and ease of access to Myriad's gold-standard HRD-testing technology we aim to help drive wide-spread and broader clinical adoption of HRD testing. This milestone demonstrates what the QIAGEN and Myriad partnership is uniquely able to deliver to pharmaceutical partners – propriety content, cutting edge assay platforms, clinical trial execution, and world-wide CDx product distribution."

QIAGEN will manage the development and distribution of the kit-based HRD test outside of the United States. The IP license grants QIAGEN the capability to collaborate with pharmaceutical partners to create an IVD-validated test, intended for use as a companion diagnostic outside of the United States. The combined regulatory expertise of QIAGEN and Myriad enables seamless compliance and integration in clinical and companion diagnostic applications.

QIAGEN's QIAseq panels enable efficient and accurate NGS library preparation. Over 4 million samples have been processed with QIAseq panels for cancer testing applications. [3]

QIAGEN has master collaboration agreements to develop and commercialize companion diagnostics with more than 30 global pharma and biotech companies – a deep pipeline that helps advance precision medicine in diverse disease indications, tailoring a patient's treatment to the genetic profile identified by companion diagnostics testing. Myriad has provided testing support for hundreds of clinical trials, has obtained 10 companion diagnostic approvals from the FDA and PMDA, and anticipates that the QIAGEN partnership will drive the expansion of the Myriad's oncology products portfolio.

About Myriad Genetic   s

Myriad Genetics is a leading genetic testing and precision medicine company dedicated to advancing health and well-being for all. Myriad develops and offers genetic tests that help assess the risk of developing disease or disease progression and guide treatment decisions across medical specialties where genetic insights can significantly improve patient care and lower healthcare costs. For more information, visit www.myriad.com .

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) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of March 31, 2024, QIAGEN employed approximately 5,900 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, including statements relating to the development of a globally distributable kit-based test for analyzing HRD status and the anticipated benefits of the Myriad and QIAGEN partnership, including that the partnership may drive the expansion of Myriad's oncology products portfolio and enable potential clinical indication expansion for MyChoice CDx. 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, 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; actions of governments, global or regional economic developments, weather or transportation delays, natural disasters, political or public health crises, and its impact on the demand for our products and other aspects of our business, or other force majeure events; 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" contained in Item 3 of 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.

Any "forward-looking statements" relating to Myriad or the development of a globally distributable kit-based test for analyzing HRD status are Myriad's management's expectations of future events as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions, and events to differ materially and adversely from those anticipated. Such factors include those risks described in Myriad's filings with the U.S. Securities and Exchange Commission, including Myriad's Annual Report on Form 10-K filed on February 28, 2024, as well as any updates to those risk factors filed from time to time Myriad's Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. Myriad is not under any obligation, and it expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise except as required by law.

Source: Qiagen N.V.
Category: Corporate

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of its QIAseq Multimodal DNARNA Lib Kit. The new kit enables seamless preparation of DNA and RNA libraries for next-generation sequencing (NGS), such as whole genome sequencing (WGS) and whole transcriptome sequencing (WTS), as well as downstream target enrichment based on hybrid-capture from a single sample.

The QIAseq Multimodal DNA/RNA Lib Kit facilitates multiomics, the studies of several omic fields like genomics, transcriptomics and proteomics, aiming to gain a deeper understanding of biological processes and systems – something crucial for studying diseases like cancer. The kit offers a streamlined and rapid workflow to generate WGS and WTS libraries from a single sample by combining chemistry optimized for DNA and RNA simultaneously. Using traditional methods, separate workflows for DNA and RNA sequencing require a large amount of sample material, labor-intensive library preparation procedures, and long turn-around times.