FDA Nod for QIAGEN's JAK2 Test Boosts Molecular Diagnostic

BMY MYGN QGEN

QIAGEN's (QGEN - Free Report) ipsogen JAK2 RGQ PCR Kit (ipsogen JAK2 assay) received FDA approval for additional use in the diagnosis of all myeloproliferative neoplasms (MPNs). In this cancer group, blood cells in the bone marrow do not mature to become healthy cells.

The FDA clearance now covers two additional types of MPN: essential thrombocythemia and primary myelofibrosis.

Notably, the ipsogen JAK2 assay is available in Europe and other markets. Per management, the assay makes it simple for hematologists and oncologists to follow recommended diagnostic testing algorithms and international guidelines for patients suspected to have MPNs.

The company is consistently trying to enhance the Molecular Diagnostic segment, which was the highest revenue grosser in the last reported quarter. Notably, the segment contributed 49% to total revenues. In this regard, QIAGEN recently announced the signing of a collaboration agreement with DiaSorin. Post collaboration, QIAGEN’s QuantiFERON-TB diagnostic test will be available in DiaSorin’s LIAISON portfolio of fully automated analyzers.

In cancer diagnosis market too the company has made several development in recent times. Last August, QIAGEN partnered with Clinical Genomics to implement the PAXgene Blood ccfDNA Tube sample collection in Clinical Genomics' Colvera colorectal cancer recurrence assay. In June, the company had received a worldwide license for biomarkers to be used in identifying patients who may have benefitted from immune-oncology therapies in cancer treatment. Also, the company collaborated with global biopharmaceutical company, Bristol-Myers Squibb Company (BMY - Free Report) for the utilization of next-generation sequencing technology to develop gene expression profiles in the same month.

According to a report by Markets and Markets, the Cancer/Tumor Profiling Market is estimated to reach a value of $8.74 billion by 2022, at a CAGR of 10.7%.

For investors keen on investing in molecular diagnostic space, some of the major players to look forward to are Myriad Genetics (MYGN - Free Report) and Genomic Health .

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