Qiagen and Incyte have entered a global collaboration to develop a companion diagnostic panel for myeloproliferative neoplasms (MPNs) for patients with mutant calreticulin (mutCALR).
Calreticulin (CALR) is a protein that regulates cellular calcium levels and protein production. Somatic mutations in the CALR gene (mutCALR) can lead to abnormal protein function.
The partnership aims to support Incyte’s investigational monoclonal therapies, currently being developed for myelofibrosis (MF) and essential thrombocythemia (ET).
Under the terms of the collaboration agreement, Qiagen will develop a multimodal panel to detect gene alterations in haematological malignancies.
The panel will use next-generation sequencing (NGS) technology and will be validated on the Illumina NextSeq 550Dx platform, part of Qiagen’s collaboration with Illumina.
Qiagen will also manage regulatory submissions and market access activities in the US, European Union (EU), and Asia-Pacific regions.
Qiagen vice president and precision diagnostics head Jonathan Arnold said: “Together with Incyte we are building a multimodal companion diagnostic using a powerful technology like next-generation sequencing to facilitate highly accurate testing for several blood cancer genes at once.
“This new partnership strengthens our role in offering companion diagnostics for the growing number of biomarkers being discovered in onco-haematology and maximising the clinical utility of the diagnostic for payor and patient benefit, thus supporting the work of innovative, science-driven companies like Incyte to improve patient outcomes.”
MPNs, which account for about 40% of haematological malignancies, are characterised by the chronic accumulation of mature blood cell types.
Identifying genomic aberrations in biomarkers like CALR is crucial, particularly in MPNs.
Incyte is developing therapies such as INCA033989 for patients with mutCALR ET or MF, targeting malignant cells while sparing normal ones.
Incyte president and research and development head Pablo Cagnoni said: “We are excited to announce this partnership with Qiagen, which will facilitate CALR testing for patients with MPNs on a global basis.
“The development of companion diagnostics for mutCALR, coupled with the potential for new medicines to selectively target disease-initiating cells, is a critical step toward changing the course of disease in patients with ET and MF.
“As a partner, QIAGEN has the proven expertise in companion diagnostics development and approvals needed to support our ongoing work and commitment to transforming the treatment of patients with CALR-mutant MPNs.”
Recently, Qiagen partnered with ID Solutions to enhance its digital PCR (dPCR) oncology research offerings, using ID Solutions’ expertise in assay development and manufacturing.
