Myeloproliferative neoplasms (MPNs) are clonal hematopoietic disorders that result in overproduction of one or more terminally differentiated blood cell types arising from the myeloid lineage. Patients suspected to be PV, ET and MF (referred to as typical MPNs) usually carry mutations on three driver genes: JAK2, MPL and CALR. In PV, JAK2 mutations exist in approximately 95% of patients. However, in ET and PMF patients, JAK2, CALR, and MPL mutations are present at frequencies of approximately 60%, 20%, and 5%, respectively. The diagnosis and prognosis of myeloproliferative neoplasm largely rely on the presence and frequency of driver mutations in JAK2, CALR, and MPL mutations. The study indicates that combined genetic tests of JAK2 V617F, JAK2 exon 12, MPL exon 10, and CALR exon 9 help improve the diagnostic rate for BCR-ABL1–negative MPN. Therefore JAK2, CALR or MPL mutation testing are necessary for the diagnosis of myeloproliferative neoplasms.

MEDx Translational Medicine has established production workshops that meet the quality management requirements of ISO 13485, with a standard production process and strict quality control. MEDx Pan MPN qPCR Panel (CE IVD) is an in vitro nucleic acid amplification test for the qualitative detection of JAK2, CALR and MPL gene mutations in genomic DNA from whole blood. Results only include the mutation status of CALR TYPE1/TYPE2, MPL W515/S505N, JAK2 V617F/K539L/exon 12 del, which can only be used for the clinical diagnosis of Myeloproliferative Neoplasms (MPN).

Product Specification：10 tests /kit

Specimen Requirements：EDTA Human whole blood

Applications: Auxiliary diagnosis and differential diagnosis of MPN patients

Test Procedures:

DNA Extraction  Reaction System Preparation  Setting up the PCR Program  Array Scanning    Data Analysis

Competitive Advantages:

• High Sensitivity：Detection limitation as low as 3ng

• Multi-platform Compatibility：Suitable for both ABI7500 and SLAN-96P,etc.

• Easier Interpretation: In the case of an amplification curve, only Ct values need to be analyzed

• Faster Workflow: Only 3 to 4 hours globally from DNA extraction to test results