QIAGEN and GENCURIX Announce QIAcuity Digital PCR IVD Assay Development Partnership

• GENCURIX partnership marks launch of new QIAcuityDx Partnering Program for third-party in vitro diagnostic (IVD) assay development

• GENCURIX signs as inaugural partner to develop multiplex oncology assays for tissue and liquid biopsies

• Partnership aims to broaden adoption of QIAcuityDx Four platform offering clinical diagnostic laboratories a range of clinical oncology assays

VENLO, Netherlands--(BUSINESS WIRE)--QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) and GENCURIX, Inc. (KOSDAQ: 229000) today announced a new partnership to develop oncology assays for use on the 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 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.”

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 reached at the end of 2024 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 at geneglobe.qiagen.com.

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.

For more information about the QIAcuityDx Partnering Program please visit: www.qiagen.com/us/applications/digital-pcr-mdx/partnering.

About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions, enabling customers to extract and gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies prepare these biomolecules for analysis while bioinformatics software and knowledge bases can be used to interpret data to find actionable insights. Automation solutions bring these processes together into seamless and cost-effective workflows. QIAGEN serves over 500,000 customers globally in Life Sciences (academia, pharma R&D and industrial applications, primarily forensics) and Molecular Diagnostics for clinical healthcare. As of March 31, 2025, QIAGEN employed approximately 5,700 people in over 35 locations worldwide. For more information, visit www.qiagen.com.

About GENCURIX

GENCURIX Inc. is a molecular diagnostics company based in Seoul, South Korea, focused on developing dPCR-based diagnostics and liquid biopsy platforms. Its products include GenesWell™ BCT, a breast cancer prognostic test, and Droplex™, a diagnostic assay series for companion and stratification testing in multiple cancer types. For more information, visit www.gencurix.com.

Forward-Looking Statement

Certain statements in this press release may constitute forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. These statements, including those regarding QIAGEN's products, development timelines, marketing and / or regulatory approvals, financial and operational outlook, growth strategies, collaborations and operating results - such as expected adjusted net sales and adjusted diluted earnings - are based on current expectations and assumptions. However, they involve uncertainties and risks. These risks include, but are not limited to, challenges in managing growth and international operations (including the effects of currency fluctuations, regulatory processes and logistical dependencies), variability in operating results, commercial development for our products to customers in the Life Sciences and clinical healthcare, changes in relationships with customers, suppliers or strategic partners; competition and rapid technological advancements; fluctuating demand for QIAGEN's products due to factors such as economic conditions, customer budgets and funding cycles; obtaining and maintaining regulatory approvals for our products; difficulties in successfully adapting QIAGEN's products into integrated solutions and producing these products; and protecting product differentiation from competitors. Additional uncertainties may arise from market acceptance of new products, integration of acquisitions, governmental actions, global or regional economic developments, natural disasters, political or public health crises, and other "force majeure" events. There is also no guarantee that anticipated benefits from restructuring programs and acquisitions will materialize as expected. For a comprehensive overview of risks, please refer to the “Risk Factors” contained in our most recent Annual Report on Form 20-F and other reports filed with or furnished to the U.S. Securities and Exchange Commission.

Source: QIAGEN N.V.

Category: PCR & Genomics