Unique Assay Improves Cancer Diagnosis for Leukemia Patients

A new CE-IVD-marked assay for calreticulin (CALR) mutations, run on a well-established RT-PCR platform, aids in establishing the diagnosis of myeloproliferative neoplasms (MPN) in line with the latest WHO recommendations and clinical guidelines.

The new ipsogen CALR RGQ PCR Kit (ipsogen CALR assay) from QIAGEN N.V. (Hilden, Germany) is intended for detection of CALR mutations in genomic DNA from patients 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 to deliver multiple clinical results within one 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. QIAsymphony is a highly flexible, widely available platform for medium throughput molecular testing. Throughput flexibility is achieved by DNA sample processing from peripheral blood using either the manual QIAamp DSP DNA Blood Mini Kit or the automated sample processing on the QIAsymphony SP instrument.

The new ipsogen CALR RGQ PCR Kit is synergistic with the CE-IVD-marked ipsogen JAK2 RGQ PCR Kit, QIAGEN’s 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). MPN 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, 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.”

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). Earlier in 2016, 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.

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