FDA Clears QIAGEN JAK2 Assay

The FDA cleared QIAGEN’s JAK2 assay) as a qualitative in vitro diagnostic test for detecting the JAK2 V617F mutation in EDTA whole blood.

The JAK2 assay is the first and only FDA-cleared kit for the JAK2 V617F mutation, which found in nearly all patients with Polycythemia Vera and belongs to a group of blood cancers known as myeloproliferative neoplasms that affect about 300,000 patients in the United States. The JAK2 V617F mutation is important for the diagnosis of Polycythemia Vera. About 9,000 new PV cases a year are diagnosed.

The clinical performance of the JAK2 assay was evaluated during a multicenter, international, prospective, interventional study. The study demonstrated high sensitivity (94.6%) and specificity (98.1%) for the diagnosis of PV, together with a 100% positive percentage agreement and a 99.4% negative percentage agreement to bi-directional sequencing.

This is the fifth FDA clearance or approval of a QIAGEN oncology-related test for personalized healthcare.