Qiagen, Hilden, Germany, has launched a CE-marked calreticulin (CALR) mutation assay to aid in establishing the diagnosis of myeloproliferative neoplasms (MPNs).

The new ipsogen CALR Rotor-Gene (RGQ) polymerase chain reaction (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 major 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 the company’s QiaSymphony and RGQ platforms, employing the CE-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 ipsogen CALR assay is the latest addition to Qiagen’s ipsogen portfolio of assays for both common and rare leukemia types. MPNs 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. MPNs include polycythemia vera, essential thrombocythemia, and various forms of primary myelofibrosis, and affect nearly 250,000 patients in Europe and 300,000 patients in the United States. The combined annual incidence rate for MPN worldwide is roughly 2.5 in every 100,000.

Christoph Menzel, Dr.rer.nat., Qiagen.

Christoph Menzel, Dr.rer.nat., Qiagen.

“We are excited to announce the launch of our new ipsogen CALR assay to help improve and facilitate patient diagnosis of MPN,” says Christoph Menzel, PhD, director of 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.”

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 MPNs.

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.

For more information, visit Qiagen.