QIAGEN Licenses Blood Cancer Biomarkers

QIAGEN N.V. has announced that it has acquired an exclusive global license to the biomarker SF3B1 from the University of Tokyo. SF3B1 is believed to play a critical role in the prognosis of patients with myelodysplastic syndromes (MDS), a group of hematological cancers in which bone marrow does not produce enough healthy blood cells.

Mutations of this gene, which is an important component of the spliceosome machinery, indicate a more favorable disease progression for patients than the “wild-type” gene, so testing for these gene variants could potentially provide important guidance for treatment based on a personalized healthcare approach to MDS.

"This novel biomarker adds important content to QIAGEN’s market-leading position in molecular tests for blood cancers. Our assays and panels cover the full range of these malignancies, including the bone marrow failure disorders known as myelodisplastic disorders. The SF3B1 biomarker is included in our GeneRead™ DNAseq Leukemia V2 gene panel for next-generation sequencing," said Vincent Fert, QIAGEN’s Personalized Healthcare Program Leader.

Fert continued, “Building on a broad portfolio of molecular diagnostics for blood cancers, QIAGEN continues to partner with clinical researchers at pharmaceutical companies and academic centers, to extend the benefits of personalized healthcare. Because several Pharma companies are developing potential anti-cancer drugs targeting the SF3B1 gene, this biomarker also holds potential for co-development as a companion diagnostic.”

QIAGEN licensed the SF3B1 biomarker in an ongoing expansion of the oncohematology offering for clinical research and diagnostics. Three additional spliceosome biomarkers implicated in various blood cancers and targeting variants in the U2AF35 (U2AF1), ZRSR2 and SFRS2 genes are also part of the license agreement. They are included in QIAGEN’s GeneRead DNAseq Leukemia V2 gene panel for next-generation sequencing (NGS), which has been launched earlier this month together with 13 other new cancer gene panels that are compatible with any NGS sequencer and customizable to include other genes or gene regions of clinical or biological interest.

The GeneRead technology provides the most cost-effective and time-efficient approach for target enrichment of assay panels for NGS. The panels use as little as 10 nanograms of starting DNA material per pool, require only three hours to enrich for targets and substantially reduce the time to go from isolated DNA sample to sequencing-ready libraries. They are compatible for use with FFPE samples, do not require specialized instruments, and achieve industry leading coverage (>96% of coding regions), specificity (>90% of reads on target) and uniformity (>90% of bases covered by at least 20% of the mean coverage depth).”

With more than 60 tests already offered worldwide for the diagnosis, prognosis and follow- up of patients with blood cancer, QIAGEN is a clear leader in research and clinical diagnosis of blood cancers.

Earlier this year, QIAGEN licensed the calreticulin (CALR) biomarker, implicated in an estimated 15% of cases of myeloproliferative neoplasms (MPNs), which involve overproduction of blood cells.

The CALR diagnostic that is under development is expected to be highly complementary to QIAGEN’s currently marketed kits for a key mutation of the Janus kinase 2 (JAK2) gene.