Qiagen to develop first QIAstat-Dx IVD panel for neurodegenerative applications

06 September 2024 | News

Collaboration with Eli Lilly set to launch the first commercially available IVD Kit for APOE genotyping

image credit- shutterstock

image credit- shutterstock

Qiagen 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. Utilising 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.

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.

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