Qiagen and Eli Lilly to Develop First QIAstat-Dx IVD Panel for Neurodegenerative Applications

QIAGEN N.V. (Venlo, the Netherlands) has entered into a collaboration with Eli Lilly and Company (Indianapolis, IN, USA) to support the development of a QIAstat-Dx in-vitro diagnostic (IVD) to detect APOE genotypes. The QIAstat-Dx panel would be the first commercially available IVD for APOE genotyping and will detect all APOE genotypes (APOE2, APOE3, APOE4) which can play a role in the diagnosis of Alzheimer’s disease. People carrying the APOE4 genotype have a greater risk of developing Alzheimer's which is the most common cause of dementia and are likely to do so earlier in life in comparison to others. Individuals carrying two copies of this genotype (homozygous) are most likely to develop clinical symptoms of the disease.

The panel will be integrated with QIAGEN's multiplex testing platform QIAstat-Dx, marking the first publicly disclosed collaboration for the system’s clinical application in neurodegenerative diseases. The QIAstat‑Dx system, designed for laboratory use, utilizes cost-efficient, single-use cartridges with built‑in sample processing and on-board reagents. Employing multiplex real-time PCR, it reliably detects genetic variants, with results in approximately one hour. With over 4,000 instruments placed worldwide, QIAstat‑Dx enjoys a strong footprint in infectious disease testing, which has 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,” added 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.”

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Eli Lilly and Company