QIAGEN to develop the first QIAstat-Dx IVD panel for neurodegenerative applications // New QIAstat-Dx panel to identify APOE genotypes, one of many factors considered in the diagnosis of patients with Alzheimer’s Disease // Collaboration set to launch the first commercially available IVD Kit for APOE genotyping
Venlo, the Netherlands, Sept. 04, 2024 (GLOBE NEWSWIRE) -- QIAGEN (: QGEN; Frankfurt Prime Standard: QIA) today announced it has entered into a collaboration with Eli Lilly and Company to support the development of a QIAstat-Dx in-vitro diagnostic (IVD) to detect APOE genotypes which can play a role in the diagnosis of Alzheimer’s disease. This collaboration represents a significant milestone as the QIAstat-Dx panel would be the first commercially available IVD for APOE genotyping.
The panel will be integrated with QIAGEN's multiplex testing platform QIAstat-Dx, marking the first publicly disclosed collaboration for a clinical application of the system in neurodegenerative diseases and adding to two more collaborations for diagnostics development programs with other companies. The QIAstat‑Dx system, designed for laboratory use, employs cost-efficient, single-use cartridges with built‑in sample processing and on-board reagents. Utilizing multiplex real-time PCR, it reliably detects genetic variants, with results in about an hour. With more than 4,000 instruments placed worldwide, QIAstat‑Dx has a strong footprint in infectious disease testing, which is now expanded into other disease and application areas.
“Our collaboration with Lilly to develop the QIAstat-Dx IVD panel underlines our commitment to advancing healthcare with a unique breadth of testing technologies and platforms, now also including multiplexing capabilities on QIAstat‑Dx,” said Jonathan Arnold, Vice President and Head of Translational Science and Precision Diagnostics at QIAGEN. “By providing precise APOE genotyping, we aim to better inform treatment considerations for Alzheimer’s patients, providing valuable insight in their diagnostic journey.”
“When offering a diagnostic test for clinical use, it is imperative that it be high-quality, accurate and accessible to patients,” said Anthony Sireci, M.D., MSc., Head of Diagnostics Development & Commercialization for Eli Lilly and Company. “We are working with QIAGEN to generate data for this APOE test because of their expertise in developing diagnostic assays and their global reach.”
The QIAstat-Dx IVD panel will detect all APOE genotypes (APOE2, APOE3, APOE4). They can play a role in the diagnosis of patients with Alzheimer's disease, which is the most common cause of dementia. People carrying the APOE4 genotype have a higher risk of developing Alzheimer's and are likely to do so earlier in life compared to others. Those who carry two copies of this genotype (homozygous) are most likely to develop clinical symptoms of the disease.
QIAGEN has more than 30 master collaboration agreements with global pharmaceutical and biotechnology companies to develop and commercialize diagnostic tests. QIAGEN’s offering to these companies encompasses technologies from next-generation sequencing (NGS) to polymerase chain reaction (PCR) and digital PCR (dPCR), sample types from liquid biopsy to tissue, and disease areas from cancer to Parkinson’s – including 14 FDA-approved PCR based companion diagnostics and a collaboration with Neuron23 announced in September 2022 to develop an NGS-based companion diagnostic for a novel Parkinson’s disease drug.
For more information about QIAGEN’s efforts in precision medicine please visit https://www.qiagen.com/us/clp/partnering-for-precision-diagnostics.
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 June 30, 2024, QIAGEN employed approximately 5,900 people in over 35 locations worldwide. Further information can be found at https://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, 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 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.
Source: QIAGEN N.V.
Category: Corporate
John Gilardi QIAGEN N.V. +49 2103 29 11711 [email protected] Domenica Martorana QIAGEN N.V. +49 2103 29 11244 [email protected] Thomas Theuringer QIAGEN N.V. +49 2103 29 11826 [email protected] Lisa Specht QIAGEN N.V. +49 2103 29 14181 [email protected]
