QIAGEN and GENCURIX announce QIAcuity digital PCR IVD assay development partnership
QIAGEN and GENCURIX, Inc. announced a new partnership to develop oncology assays for use on the QIAcuityDx platform.
GENCURIX is the first development partner under QIAGEN’s QIAcuityDx Partnering Program. This 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.
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.
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.