QIAGEN Launches Unique CALR Mutation Assay for MPN Diagnosis

QIAGEN have announced the European launch of a unique CE-IVD marked calreticulin (CALR) mutation assay to aid in establishing the diagnosis of myeloproliferative neoplasms (MPN).

The new ipsogen CALR RGQ PCR Kit (ipsogen CALR assay) is intended for the detection of CALR mutations in genomic DNA from subjects suspected of MPN. It enables identification of the two majors CALR mutations, Type 1 and Type 2, and detects additional mutations in the CALR exon 9 region. The ipsogen CALR assay simplifies CALR testing by covering various relevant mutations in a real-time PCR-based assay to deliver multiple clinical results in less than a working day. The test runs on QIAGEN’s QIAsymphony® and Rotor-Gene® (RGQ) platforms, employing the CE-IVD marked Rotor-Gene Q MDx 5Plex HRM Platform real-time cycler with automated analysis and interpretation using the Rotor Gene AssayManager® software. Maximum throughput flexibility is achieved by DNA sample processing from peripheral blood, using either the manual QIAamp® DSP DNA Blood Mini Kit or the fully automated sample processing on the QIAsymphony SP instrument. The new ipsogen CALR RGQ PCR Kit is highly synergistic with the CE-IVD marked ipsogen JAK2 RGQ PCR Kit, QIAGEN’s market leading solution to detect the V617F mutation in the janus kinase 2 (JAK2) gene, as CALR mutations can be detected from the same patient sample.

The ipsogen CALR assay is the latest addition to QIAGEN’s ipsogen portfolio of assays for both common and rare leukemia types. MPN are a group of blood cancers characterized by significant symptoms and complications such as thrombosis (blood clots) and a high risk of transformation into acute leukemia. MPN include polycythemia vera (PV), essential thrombocythemia (ET) and various forms of (primary) myelofibrosis (PMF), and affect nearly 250.000 patients in Europe and 300.000 patients in the US. The combined annual incidence rate for MPN worldwide is roughly 2.5 in every 100.000.

“We are excited to announce the launch of our new ipsogen CALR assay to help improve and facilitate patient diagnosis of MPN. The CALR assay is a very important addition to QIAGEN’s market leading ipsogen portfolio of molecular assays that are advancing treatment standards for patients with blood cancers”, said Dr. Christoph Menzel, Director Global Product Management Personalized Healthcare and Oncology at QIAGEN. “We strongly believe our IVD Sample to Insight® workflows for biomarkers such as CALR and JAK2 will make it easier for hemato-oncologists to follow recommended diagnostic testing algorithms and international guidelines, and further demonstrates QIAGEN’s leadership and commitment to innovation in molecular diagnostics."

The importance of CALR mutations in MPN was first described in December 2013 in two important papers published in the New England Journal of Medicine (Klampfl T. et al. and Nangalia J. et al). In April 2014 QIAGEN obtained the exclusive worldwide license rights to intellectual property covering specific mutant alleles of the CALR gene from the Research Center for Molecular Medicine of the Austrian Academy of Sciences, whose scientists led the team that discovered the presence of CALR mutations in MPN (read press release here). Earlier this year, mutations in CALR were included in addition to JAK2 mutations as a major diagnostic criterion for MPN in the updated WHO guidelines for the classification of myeloid neoplasms and acute leukemia. Both CALR and JAK2 V617F mutations were recently described in clinical guidelines to have prognostic significance. This emphasizes the outstanding importance of CALR mutations, together with JAK2 mutations, in the diagnosis and prognosis of MPN.

QIAGEN also has an exclusive license to intellectual property rights for the detection of the V617F specific mutation in the JAK2 gene for diagnostic purposes. The Company’s ipsogen product line includes more than 20 assays and is considered the market leading portfolio in hemato-oncology testing.

QIAGEN’s QIAsymphony platform is one of the most widely available platforms for medium throughput molecular testing and provides unrivalled flexibility for processing and analysis of samples in laboratory developed tests or validated and regulated assays. The Company expects more than 1750 units to be placed by the end of 2016. The QIAsymphony-RGQ family benefits from the widest range of CE marked assays in this category, spanning therascreen assays for solid tumors, ipsogen assays for blood cancers, artus assays for infectious diseases, as well as certal assays for food testing and cador assays for veterinary testing.