Qiagen and Gencurix Partner on Development of QIAcuity Digital PCR IVD Assay

QIAGEN (Venlo, Netherlands) and GENCURIX (Seoul, South Korea) have entered into a new partnership to develop oncology assays for use on the

labmedica.com/expo/product/19057/digital-pcr-system-model-qiacuitydx" target="_blank">QIAcuityDx platform, a high-performance digital PCR system designed for clinical diagnostics.

GENCURIX is the first development partner under QIAGEN’s QIAcuityDx Partnering Program. This important advancement marks a significant step towards establishing a broad menu of in vitro diagnostic (IVD) assays on the QIAcuityDx Four platform, increasing access to digital PCR diagnostics. The new partnership combines QIAGEN’s QIAcuityDx digital PCR platform to advance sensitive, cost-effective oncology diagnostics with GENCURIX’s expertise in multiplex assay development. The aim is to enable the creation of oncology IVD assays for both tissue and liquid biopsy applications, with flexible commercialization options and global reach through QIAGEN’s Partnering Program.

The QIAcuityDx Partnering Program aims to support third-party assay development on QIAcuityDx, which is a member of the QIAcuity family of digital PCR systems, that has achieved more than 2,700 cumulative placements since launch. These menu initiatives for clinical applications will leverage this installed base as well as build on the 2024 milestone of launching more than 130 new assays for QIAcuity for research applications, and complemented by the extensive menu of custom assays available on QIAGEN’s GeneGlobe platform. GENCURIX will apply its proven expertise in complex, multiplex IVD assay development to create oncology tests.

The QIAcuityDx Four platform delivers a scalable and high-performance digital PCR solution for clinical laboratories. As global adoption of digital PCR grows, it is increasingly recognized as a complementary method to qPCR and NGS—particularly in oncology, infectious diseases, and rare genetic disorders. Through the QIAcuityDx Partnering Program, QIAGEN is opening its platform to third-party developers, encouraging innovation in order to offer laboratories a continuously expanding range of validated diagnostic tests.

GENCURIX will begin developing multiple oncology assays and pursue IVD regulatory approvals. GENCURIX, as the legal manufacturer of the assays, will be fully responsible for obtaining and maintaining all necessary regulatory approvals and certifications. Upon approval, the assays will be marketed through QIAGEN’s global commercial infrastructure as part of the QIAcuityDx Partnering Program, ensuring streamlined access for laboratories worldwide.

By enabling third-party development, QIAGEN is addressing the growing demand for broader access to high-precision and cost-efficient diagnostic assays. The collaboration with GENCURIX represents the first step in building a robust and innovative assay ecosystem for the QIAcuityDx platform, backed by QIAGEN’s distribution capabilities and technical support.

“The QIAcuityDx Partnering Program is designed to enable the generation of a broad menu of IVD assays on the platform,” said Jonathan Arnold, Vice President and Head, Partnering for Precision Diagnostics at QIAGEN. “The first partnership in this program with GENCURIX is an exciting moment, giving our oncology testing customers access to high-quality IVD assays that complement other established methods such as qPCR and NGS. We look forward to working with GENCURIX within this promising partner program.”

“This strategic partnership with QIAGEN represents a major inflection point for expanding our oncology molecular diagnostic technologies into the global market,” said Sang Rae Cho, CEO at GENCURIX. “We are confident that the synergy between our diagnostic content and QIAGEN’s platform will lead to global-standard precision cancer diagnostic solutions.”

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