QIAGEN Adds Promising Genomic Biomarkers for Assessing Prognosis in Treatment of Blood Cancers to Personalized Healthcare Pipeline

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Jul 24, 2014, 04:00 ET

HILDEN, Germany, and MARSEILLE, France, July 24, 2014 /PRNewswire/ --

Exclusive global license from University of Tokyo enables development of QIAGEN assays for SF3B1 mutations, including next-generation sequencing (NGS) gene panels, for blood cancers
Mutations of SF3B1 gene, to be targeted by new test, indicate favorable prognosis for patients with bone marrow disorders known as myelodysplastic syndromes
QIAGEN sees potential for developing companion diagnostics to guide treatment with new anti-cancer compounds under development that target the SF3B1 gene

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced 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^[^TM^] DNAseq Leukemia V2 gene panel for next-generation sequencing," said Vincent Fert, QIAGEN's Personalized Healthcare Program Leader. "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.

About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample & Assay Technologies that are used to transform biological materials into valuable molecular information. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are then used to make these isolated biomolecules visible and ready for interpretation. QIAGEN markets more than 500 products around the world, selling both consumable kits and automation systems to customers through four customer classes: Molecular Diagnostics (human healthcare), Applied Testing (forensics, veterinary testing and food safety), Pharma (pharmaceutical and biotechnology companies) and Academia (life sciences research). As of March 31, 2014, QIAGEN employed approximately 4,000 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.

Certain of the statements contained in this news release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, markets, strategy or operating results, including without limitation its expected operating results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products in applied testing, personalized healthcare, clinical research, proteomics, women's health/HPV testing and nucleic acid-based molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN's products (including fluctuations due to general economic conditions, the level and timing of customers' funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors' products; market acceptance of QIAGEN's new products, the consummation of acquisitions, and the integration of acquired technologies and businesses. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).