QIAGEN and Incyte Forge Global Collaboration to Develop Companion Diagnostic Panel for Patients With Mutant CALR-Positive Myeloproliferative Neoplasms
QIAGEN N.V. and Incyte today announced a significant new collaboration aimed at improving the standard of care for patients battling myeloproliferative neoplasms (MPNs) — a group of rare but serious blood disorders — by developing a novel, multimodal diagnostic panel designed to aid clinician decision-making and enable the delivery of more personalized treatments.
This strategic collaboration brings together QIAGEN’s expertise in diagnostic technologies and Incyte’s extensive portfolio of investigational therapies in hematologic disorders, reflecting both companies’ shared mission to enable a new era of precision medicine for patients with difficult-to-treat MPNs, especially those whose disease is driven by mutations in the calreticulin (CALR) gene.
MPNs: An Unmet Medical Need
Myeloproliferative neoplasms represent a group of related disorders stemming from abnormalities in hematopoietic (or blood-forming) cells in the bone marrow. This group includes essential thrombocythemia (ET), myelofibrosis (MF), and polycythemia vera (PV) — collectively accounting for roughly 40% of hematologic malignancies. MPNs typically manifest through the overproduction of a particular kind of blood cell, which can contribute to a range of complications, from an increased risk of thrombosis (forming abnormal blood clots) to progression toward acute leukemia.
One of the key contributors to disease pathophysiology in many MPNs is mutations in genes such as JAK2, MPL, and, notably, CALR. The mutations within the calreticulin (CALR) gene — predominantly in exon 9 — enable the production of mutant forms of calreticulin (mutCALR) that promote the abnormal growth of hematopoietic cells, fueling the progression of the disease. Importantly, these mutations are largely unique to the disease cells and are not present in normal hematopoietic cells — making them an ideal target for both diagnostic assays and targeted therapeutic interventions.
Incyte’s Commitment to Innovation in MPNs
Incyte, a renowned biopharmaceutical innovator, stands at the forefront of developing novel therapeutic strategies for patients with myeloproliferative neoplasms. This includes its lead candidate, INCA033989 — a first-in-class monoclonal antibody designed to directly target mutant calreticulin — in patients with essential thrombocythemia (ET) and myelofibrosis (MF).
This therapeutic approach holds immense promise, as it offers a way to selectively attack disease-initiating cells while preserving normal hematopoietic cells — a key consideration for improving patient outcomes while reducing side effects. Incyte’s ability to pursue a precision medicine approach is made possible by the growing understanding of the genomic abnormalities that drive disease progression in MPNs — knowledge that a sophisticated diagnostic can help identify.
QIAGEN’s Companion Diagnostic Expertise
This collaboration will enable QIAGEN to leverage its extensive experience in developing and validating companion diagnostics alongside its proprietary technologies for genomic testing. QIAGEN plans to develop a multimodal diagnostic panel employing powerful next-generation sequencing (NGS) to enable the sensitive and accurate detection of clinically relevant mutations in hematologic malignancies — especially mutations in CALR — alongside other key aberrations.
This diagnostic panel will aid clinicians in guiding their treatment decisions by identifying the patients most likely to respond to Incyte’s innovative therapy. Furthermore, QIAGEN will validate the diagnostic panel’s performance and robustness, ensuring its utility across a range of laboratory settings.
Collaborative Validation and Global Market Access
The new diagnostic will be powered by Illumina’s NextSeq 550Dx platform, reflecting QIAGEN’s longstanding collaboration with Illumina (NASDAQ: ILMN) to enable broad, high-throughput, and accurate NGS diagnostics for patient care. QIAGEN is poised to leverage its extensive expertise in navigating the complex regulatory landscape for diagnostics in multiple jurisdictions — including the United States, European Union, and Asia-Pacific — to maximize the diagnostic’s reach and patient impact.
This process includes securing appropriate regulatory approvals and developing a clear market access strategy alongside stakeholders, payors, health care providers, and regulators. QIAGEN’s extensive knowledge of this landscape, combined with its strong commercial presence and diagnostic portfolio, will aid in delivering this companion diagnostic to patients in a timely and efficient manner.
Collaborative Comments from QIAGEN and Incyte
“Together with Incyte, we are developing a multimodal companion diagnostic that utilizes powerful technologies, such as next-generation sequencing, to enable the accurate and comprehensive testing of numerous genes that contribute to the progression of MPNs,” said Jonathan Arnold, Vice President and Head of Partnering for Precision Diagnostics at QIAGEN. “This new collaboration further strengthens QIAGEN’s role in delivering advanced diagnostics for a growing number of clinically relevant biomarkers in onco-hematology, thereby maximizing their clinical utility and helping payors, providers, and patients make more-informed treatment decisions.”
Pablo J. Cagnoni, M.D., President and Head of Research and Development at Incyte, added: “After the strong data we presented at the European Hematology Association meeting demonstrating the potential of our first-in-class mutCALR-targeted antibody, we’re excited to collaborate with QIAGEN in developing a diagnostic that can identify which patients may benefit most from this new therapeutic approach. QIAGEN brings extensive expertise in developing diagnostics alongside novel treatments, reflecting a shared passion for improving outcomes in patients with MPNs. This collaboration underscores our collective commitment to changing the standard of care for individuals battling these challenging disorders.”
This collaboration signals a new era for the care of patients with myeloproliferative neoplasms, reflecting the growing understanding of disease mechanisms, the power of genomic diagnostics, and the ability to match patients with tailored therapies. QIAGEN and Incyte are poised to make a significant, measurable, and meaningful improvement in patient outcomes — delivering greater hope for those living with these challenging disorders.
