QIAGEN Adds Promising New Biomarker to Pipeline of Personalized Healthcare Assays

Reliable diagnostic tools under development for mutations of calreticulin (CALR) are expected to benefit patients with blood disorders known as myeloproliferative neoplasms

QIAGEN N.V. has announced that it has acquired an exclusive worldwide license to the biomarker calreticulin (CALR), whose recently discovered mutations are found in an estimated 15% of cases of myeloproliferative neoplasms (MPNs), a group of blood disorders. QIAGEN licensed the technology from CeMM Vienna, the Research Center for Molecular Medicine of the Austrian Academy of Sciences, whose scientists led a team that discovered the presence of mutations of the CALR protein in MPNs.

QIAGEN plans to develop a molecular diagnostic test for the CALR mutations to offer each patient a clearer prognostic profile and to guide disease management. Development of a CALR diagnostic test is expected to be highly complementary to QIAGEN’s kits for a key mutation of the Janus kinase 2 (JAK2) gene.

Myeloproliferative neoplasms, a group of blood disorders involving overproduction of blood cells, are chronic diseases that can lead to several complications including thrombosis (blood clots) and in some cases difficult-to-treat acute leukemia. QIAGEN already has an exclusive license for the JAK2 V617F mutation, which is present in about 75% of patients with MPNs. According to an article published in the New England Journal of Medicine in December 2013 by the CeMM team led by Robert Kralovics, patients with CALR mutations suffer from a milder form of the disease than those with the JAK2V617F mutation, including a lower risk of thrombosis and a higher survival rate.

"This novel biomarker offers an exciting opportunity to broaden QIAGEN’s market-leading position in developing molecular diagnostics for the whole range of blood disorders. Together, the JAK2 and CALR biomarkers give us the ability to deliver personalized insights regarding diagnosis, prognosis and disease management for patients with myeloprofilerative disorders," said Peer M. Schatz, Chief Executive Officer of QIAGEN. “We are now looking forward to developing clinically proven tests for detection of CALR mutations on Rotor-Gene Q MDx, which is part of our industry-leading QIAsymphony family of automated platforms. CALR and JAK2 could also be promising targets for companion diagnostics as future drug candidates for these blood disorders may be linked to these biomarkers.”

Giulio Superti-Furga, Scientific Director of CeMM, said: “We estimate that up to 3 million people worldwide suffer from myeloproliferative neoplasms, and discovery of the CALR mutation by our CeMM and Medical University of Vienna research teams is a very important finding for the benefit of these patients. We are pleased to license the CALR biomarker to QIAGEN. The development of a standardized test will enable physicians to provide improved patient care. At the same time, our researchers will continue to advance the understanding of these diseases and to focus on developing novel treatment options. CeMM is constantly investing in basic research aimed at obtaining new insights in potential diagnostics and therapeutics.”

With the technologies licensed from CeMM, QIAGEN plans to develop commercial kits for the detection of CALR mutations and seek regulatory approvals for those products. These diagnostics will join the growing portfolio of kits designed to run on the QIAsymphony automation platform. In addition, the license from CeMM includes potential use of the biomarker in next-generation sequencing applications.