Qiagen Adds to Leading Molecular Cancer Menu with FDA-Cleared JAK2 Test Kit

Prognostic and Other Evaluative Tests Kits Join Companion Diagnostics in U.S. Cancer Diagnostics.  Kalorama Information covers molecular in vitro diagnostics (IVD) markets for cancer and blood disorders inThe World Molecular Diagnostics Market, 7th Ed.

The U.S. Food and Drug Administration (FDA) recently cleared Qiagen’s ipsogen JAK2 RGQ PCR Kit for detection of the V617F mutation on the JAK2 gene associated with the myeloproliferative disorder polycythemia vera. The cancer test kit assists patient evaluation for the particular form of leukemia and is routinely tested in myeloproliferative neoplasms (MPNs) negative for mutation in the BCR-ABL gene. Kit availability for JAK2 testing will make the test more widely available to health systems for the implementation of personalized medicine for leukemia patients. Qiagen’s incremental market opportunity with the test kit is less than $10 million, but the molecular cancer diagnostics heavyweight has built its global 20% market share on just such individually small product markets.

Companion diagnostics are Qiagen’s core products in molecular cancer diagnostics, including co-labeled kits for EGFR, KRAS and BRAF mutations. While companion assays will continue to grow the molecular cancer diagnostics market, industry development activities are also focused on liquid biopsy tests that can broadly address cancer testing – from early cancer detection and multiplex profiling of cancer cells through non-invasive tumor monitoring. Panel tests performed using PCR or next-generation sequencing (NGS) are expected to become an increasingly significant element in the U.S. molecular cancer diagnostics market. The recent clearance of Qiagen’s JAK2 test kit can be interpreted as a step by the company in preparation for the submission of other non-pharmacodiagnostic tests or a leukemia panel.