Sysmex Corporation (HQ: Kobe, Japan; Chairman & CEO: Hisashi Ietsugu) announces its launch of the ipsogen JAK2 DX reagent. The company received marketing approval on the reagent on December 19, 2018. This product is a gene testing kit that measures the JAK2V617F mutation1 quantitatively, used in the diagnosis of certain hematopoietic tumors generally referred to as blood cancers, specifically polycythemia vera (PV), essential thrombocythemia (ET), and primary myelofibrosis (PMF).
This product obtained health insurance coverage effective January 1, 2020, becoming Japan’s first diagnostic aid for PV, ET, and PMF to be covered. Going forward, tests using the reagent will be covered under health insurance. This is expected to increase the opportunities for more patients to receive testing.
Product Overview | |||
Generic name: | JAK2 gene mutation kit | ||
Name: | ipsogen JAK2 DX reagent (in vitro diagnostic medical device registration number: 23000EZX00061000) |
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Target market: | Japan | ||
Manufacture and sale: | Sysmex Corporation |
Details of Insurance Coverage | |||
Item of measurement: | JAK2 gene test | ||
Measurement method: | Allele-specific quantitative PCR (AS-qPCR) method | ||
Objective of use: | To measure the percentage of JAK2V617F mutations in genome DNA extracted from blood components (diagnostic aid for polycythemia vera, essential thrombocythemia and primary myelofibrosis) | ||
NHI points: | 2,504 |
Terminology | |||
1 | JAK2V617F mutation: JAK2 refers to the tyrosine kinase JAK2 protein, which transduces the signals for regulating the growth and differentiation of blood cells. JAK2V617F indicates a mutation in which an amino acid (valine) at position 617 of JAK2 protein is replaced by phenylalanine. |
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2 | Oncogenesis of hematopoietic stem cells: Blood cells (red blood cells, white blood cells, and platelets) are differentiated from hematopoietic stem cells in the bone marrow. Gene mutations in these hematopoietic stem cells leads to oncogenesis, causing a rapid increase of the blood cells. |
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3 | Allele burden: A quantitative expression of the degree of the JAK2V617F mutation. |