The diagnostic test, already available in Europe, is an addition to Qiagen’s assay kits and genetic panels for the automated diagnosis of cancer. 

The FDA has cleared Qiagen’s ipsogen JAK2 assay, an in vitro diagnostic test for the JAK2 V617F mutation, which is found in nearly all patients with Polycythemia Vera (PV). This disease is a type of blood cancer that is diagnosed in 9,000 people every year. Although PV can be life-threatening without treatment, its diagnosis is difficult because the disease develops slowly and patients might not notice it for years.

The kit, based on PCR technology, complements existing Qiagen’s tests for blood cancer and solid tumors, sold under the brands ipsogen and therascreen, respectively. Together, they cover around 30 oncology biomarkers.

Qiagen FDA approval test leukemia

Of note, the technology behind the new kit comes from Ipsogen, a biotech in Marseille that was acquired by Qiagen back in 2012. The deal is definitely paying off for the German company since it has already launched several tests and equipment to for blood cancer testing based on Ipsogen’s technology.

This approval also marks one step further for Qiagen in the development of a single automated PCR platform for cancer diagnosis. In addition, the company is working on the integration all genes into leukemia panels for tests based on next-generation sequencing (NGS) technology.

Integrated diagnostic systems are one of the key steps to make personalized medicine a reality. The technology is generating huge expectations, but there are still many more challenges that need to be tackled, such as data accessibility or achieving reimbursement.


Images from CA-SSiS /Shutterstock; Qiagen

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