Success Story
QIAGEN
Empowering a High-Growth PCR Platform with Ultra-Sensitive, Sample-to-Result Performance Through Collaborative Innovation
Product
QIAstat-Dx
Customer:
QIAGEN
Market/Application:
Molecular Diagnostics/Infectious Disease
QIAGEN has partnered with LRE to develop the QIAstat-Dx platform, a highly integrated, sample-to-result PCR instrument delivering ultra-sensitive fluorescence detection, rapid thermal cycling, and robust clinical deployment. The platform spans from a compact near-patient testing device to a higher-throughput automated system, designed for broad regulatory approval and seamless hospital network integration.
The program involved parallel development of instrument hardware, cartridges, and assays by multiple parties, creating substantial technical and programmatic complexity. LRE’s modular, phased instrument development approach enabled early assay validation by QIAGEN while progressively de-risking the final industrialized devices.
This approach was intentionally structured to:
- Align with assay development and clinical trials in parallel
- Deliver a fully verified, production-ready instrument
- Enable scalable series production
These efforts significantly shortened time-to-market while ensuring regulatory and manufacturing readiness. The resulting platform delivers outstanding performance across optical, mechanical, thermal, and software domains, supports FDA 510(k) clearance, and integrates seamlessly into hospital IT systems—while maintaining a clear path to scalable series production.
Major Challenges
- Complex disposable cartridge requiring precision mechanical actuation
-
Very tight system integration within a small physical footprint
- High-precision optical fluorescence measurement under stringent noise and stability constraints
- Alignment with assay and cartridge development
Our Solution
- Modular optical, thermal, mechanical, and pneumatic subsystems enabling rapid end-to-end assay validation
- Fully integrated functional instruments with final industrial design and optimized HMI supporting clinical and usability studies
- Product-mature pilot systems enabling verification, customer evaluation, and series production readiness
- Miniaturized, high-density system architectures with fully customized modules optimizing performance, cost, and IP protection
- FDA and ISO 13485–compliant development from concept through industrialization
- Seamless transfer to scalable production with long-term lifecycle and supply-chain support
Proven Expertise
- Development and industrialization of a high-performance, sample-to-result PCR diagnostic platform
- Deep expertise in optical, mechanical, thermal, and mechatronic system integration for molecular diagnostics
- Fully customized, modular architecture optimized for performance, cost, and IP protection
- FDA and ISO 13485–compliant development from early concept through series production
- Seamless transition to scalable manufacturing with long-term lifecycle and supply-chain support