QIAGEN and GENCURIX Team Up to Develop Digital PCR Oncology Tests

QIAGEN and GENCURIX Partner to Digitize the Healthcare Sector

Announcement

QIAGEN and GENCURIX partnered to develop oncology assays to perform on the QIAcuityDx platform. A platform popular for its excellent performance in the digital PCR system has been initiated for clinical diagnostics. GENCURIX's partnership intention is to launch a new QIAcuityDx partnering program for in vitro diagnostic (IVD) assay development (third party). GENCURIX signed the partnership agreement as the inaugural partner that will help to develop multiple oncology assays for liquid biopsies and tissue. This partnership has been developed to expand the vast QIAcuityDx four platform that provides clinical diagnostic laboratories with the majority of clinical oncology assays.

About Partnership

GENCURIX is the first ever well-established partner under QIAGEN’s QIAcuityDx partnering program. This advancement and enhancement is a valuable step towards developing a broader concept of in vitro diagnostic (IVD) assays on the QIAcuityDx four platform and elevating availability to digital PCR diagnostics. This partnership merges this digital platform with low-cost oncology diagnostics, along with the expertise of GENCURIX, further contributing to the multiplex assay development. The overall focus is to offer the best innovation of oncology IVD assays for liquid biopsy applications and tissue. The accomplishment will be defined after a successful access to various marketing options and recognition through QIAGEN’s partnering program.

Program

The QIAcuityDx partnering program is contributing to the third-party assay development on QIAcuityDx. The QIAcuityDx is a member of the QIAcuityDx digital PCR systems, consisting of 2,700 cumulative placements by the end of 2024 since its launch. The current concepts for clinical applications will accelerate the installed base and the 130 new assays for QIAcuity for research applications, which was a decided milestone since 2024. To support this program, GENCURIX will initiate its expertise in force for multiplex IVD assay development to create an effective oncology test. In support of the expertise, the QIAcuityDx four platform elevates the scalability and performance in digital PCR solutions for clinical laboratories.

As the acceptance of digital PCR rises, it will be crowned as a complementary method to NGS and qPCR, mostly in rare genetic disorders, oncology, and infectious diseases. The QIAcuityDx partnering program will help QIAGEN introduce a platform for third-party developers by bolstering innovation for laboratories to achieve vast expansion to validate diagnostic tests.

Progressive Strategy

GENCURIX will start to develop several oncology assays and ensure IVD regulatory approvals. GENCURIX, being a legal manufacturer of the assays, will be liable to obtain all required regulatory certificates and approvals. By initiating third-party development, QIAGEN will analyze the rising demand to expand its access to low-cost diagnostic and accurate assays. QIAGEN’s technical support and distribution thrive in this partnership.