QIAGEN and Incyte have announced a global strategic collaboration to co-develop a next-generation sequencing (NGS)-based companion diagnostic panel for myeloproliferative neoplasms (MPNs), a group of rare blood cancers. The collaboration supports Incyte’s investigational therapies, including its monoclonal antibody INCA033989, which specifically targets mutant calreticulin (mutCALR) in patients with essential thrombocythemia (ET) and myelofibrosis (MF).
Under a Master Collaboration Agreement, QIAGEN will develop a multimodal diagnostic panel using advanced NGS technology to detect clinically relevant gene alterations associated with hematologic malignancies. The diagnostic panel will be validated on the Illumina NextSeq 550Dx platform, aligning with QIAGEN’s ongoing partnership with Illumina (NASDAQ: ILMN). This approach ensures compatibility with globally distributed NGS diagnostic platforms, facilitating widespread laboratory adoption and standardized testing.
QIAGEN will also lead the regulatory submission and market access processes in the United States, European Union, and Asia-Pacific markets. The joint effort reflects both companies' commitment to accelerating the availability of precision diagnostics for complex blood cancers and supporting global patient access to innovative testing solutions.
Myeloproliferative neoplasms represent approximately 40% of hematological malignancies and are characterized by the chronic accumulation of mature blood cells. The identification of genetic alterations, especially in biomarkers such as CALR, plays a pivotal role in guiding diagnosis and therapy selection in MPNs. Incyte’s INCA033989 is designed to selectively target mutCALR-expressing cells while sparing healthy cells—offering the potential for a disease-modifying treatment approach.
Dr. Pablo J. Cagnoni, President and Head of R&D at Incyte, emphasized the importance of the partnership: “Following the promising data we presented at EHA from our first-in-class mutCALR-targeted antibody, this collaboration with QIAGEN is essential for enabling broad access to CALR testing. Companion diagnostics are critical for guiding personalized therapies and improving outcomes in patients with ET and MF.”
Jonathan Arnold, Vice President and Head of Partnering for Precision Diagnostics at QIAGEN, added, “Together with Incyte, we are building a cutting-edge NGS companion diagnostic to support multi-gene blood cancer testing. This partnership expands our precision diagnostics portfolio in onco-hematology, while helping deliver clinical and economic value for patients and healthcare systems worldwide.”