QIAGEN and Lilly collaborate to support development of a QIAstat-Dx IVD panel that identifies patients at risk for developing Alzheimer’s disease

Rhea-AI Summary

QIAGEN (NYSE: QGEN) has announced a collaboration with Eli Lilly to develop a QIAstat-Dx in-vitro diagnostic (IVD) panel for APOE genotyping, which can aid in the diagnosis of Alzheimer's disease. This marks the first commercially available IVD for APOE genotyping and expands QIAstat-Dx's applications into neurodegenerative diseases.

The QIAstat-Dx system, with over 4,000 instruments worldwide, uses single-use cartridges and multiplex real-time PCR to detect genetic variants in about an hour. The new panel will detect all APOE genotypes (APOE2, APOE3, APOE4), with APOE4 carriers having a higher risk of developing Alzheimer's earlier in life.

This collaboration adds to QIAGEN's portfolio of over 30 master agreements with pharmaceutical and biotech companies for diagnostic test development across various technologies and disease areas.

Positive

• First commercially available IVD for APOE genotyping
• Expansion of QIAstat-Dx applications into neurodegenerative diseases
• Over 4,000 QIAstat-Dx instruments placed worldwide
• Collaboration with major pharmaceutical company Eli Lilly
• Adds to QIAGEN's portfolio of over 30 master agreements for diagnostic test development

Negative

• None.

Medical Research Analyst

This collaboration between QIAGEN and Eli Lilly marks a significant advancement in Alzheimer's disease diagnostics. The development of the first commercially available IVD for APOE genotyping on the QIAstat-Dx platform could revolutionize early detection and risk assessment. The APOE4 genotype is a well-known risk factor for Alzheimer's and this test could provide important information for patient care and treatment strategies.

The QIAstat-Dx system's ability to deliver results in about an hour, coupled with its existing global footprint of over 4,000 instruments, suggests potential for rapid and widespread adoption. This could lead to more personalized treatment approaches and improved patient outcomes in Alzheimer's care. However, it's important to note that while APOE genotyping is valuable, it's not definitive for diagnosis and other factors must be considered in the complex landscape of Alzheimer's disease.

Financial Analyst

QIAGEN's collaboration with Eli Lilly could significantly impact its market position in the growing field of neurodegenerative disease diagnostics. This move diversifies QIAGEN's portfolio beyond infectious diseases, potentially opening up new revenue streams. The global Alzheimer's diagnostics market is projected to reach $12 billion by 2026, growing at a CAGR of 8.2%.

With over 30 master collaboration agreements already in place, QIAGEN demonstrates strong partnerships in the pharmaceutical industry. This new venture could enhance investor confidence in the company's growth strategy and innovation pipeline. However, investors should consider the lengthy development and regulatory approval processes for IVDs, which could impact the timeline for realizing financial benefits from this collaboration.

Market Research Analyst

This collaboration positions QIAGEN at the forefront of a important market need in Alzheimer's diagnostics. With an aging global population and increasing focus on early detection of neurodegenerative diseases, the demand for such diagnostic tools is likely to grow substantially. The QIAstat-Dx platform's expansion into neurodegenerative applications could open doors to a broader market beyond infectious diseases.

However, market adoption may face challenges such as healthcare provider education, reimbursement policies and competition from other diagnostic methods. The success of this venture will depend on factors like clinical validation, cost-effectiveness and integration into existing diagnostic workflows. QIAGEN's established global presence and Lilly's expertise in Alzheimer's research create a strong foundation for market penetration, but the pace of adoption and market share gains should be closely monitored by investors.

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 (NYSE: 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

FAQ

What is the purpose of QIAGEN's collaboration with Eli Lilly for the QIAstat-Dx IVD panel?

The collaboration aims to develop a QIAstat-Dx in-vitro diagnostic panel to detect APOE genotypes, which can play a role in the diagnosis of Alzheimer's disease. This will be the first commercially available IVD for APOE genotyping.

How does the QIAstat-Dx system work for genetic variant detection?

The QIAstat-Dx system uses cost-efficient, single-use cartridges with built-in sample processing and on-board reagents. It employs multiplex real-time PCR to reliably detect genetic variants, providing results in about an hour.

What APOE genotypes will the new QIAstat-Dx IVD panel detect?

The QIAstat-Dx IVD panel will detect all APOE genotypes: APOE2, APOE3, and APOE4. People carrying the APOE4 genotype have a higher risk of developing Alzheimer's disease and are likely to do so earlier in life compared to others.

How many QIAstat-Dx instruments are currently in use worldwide?

QIAGEN has placed over 4,000 QIAstat-Dx instruments worldwide, primarily used for infectious disease testing. The collaboration with Eli Lilly expands its applications into neurodegenerative diseases.