VENLO, The Netherlands, February 8 QIAGEN(NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced that its whollyowned subsidiary DxS has acquired the global and exclusive licence forbiomarker PI3K from Johns Hopkins University to develop real-time-PCR andendpoint PCR assays. Research has shown that variation in the PI3K gene couldbe a key biomarker for use as a companion diagnostic with certain cancertreatments. The studies suggest that mutations in the PI3K oncogene arepredictive for the success of certain treatments of patients suffering fromlung, breast, colorectal and other cancers. QIAGEN has an active PI3K assaydevelopment and partnering program with pharmaceutical companies to developand market tests for new cancer drug candidates. Financial details were notdisclosed.
QIAGEN already markets a PI3K test for research use. This test is basedon real-time polymerase chain reaction (RT-PCR), a widely availabletechnology to make DNA sequences visible through amplification. The assay,which uses technology that allows a very significant sensitivity, detectsmutations frequently missed by sequencing methods.
The patent for PI3K mutations in human cancers was initially filed byresearchers at Johns Hopkins who assessed the biomarker during theirevaluation of tyrosine kinase inhibitors targeting the EGFR (Epidermal GrowthFactor Receptor) pathway. Various EGFR inhibiting drugs have shown to be noteffective in cancer patients with mutations in genes of the EGFR pathway(EGFR, K-RAS, B-RAF etc.). QIAGEN already markets several tests determiningthe mutation status in oncogenes. This portfolio includes tests for mutationsof K-RAS and B-RAF, which are indicative for metastatic colorectal, lung andother cancers. The K-RAS test is CE-marked for companion diagnostic use withEGFR inhibitors Vectibix(R) and Erbitux(R) and is expected to be submittedfor FDA approval shortly.
"This license agreement is another step forward for QIAGEN and for theuse of novel therapeutics that rely on the widespread availability of therequired PI3K companion diagnostic test", said Peer M. Schatz, CEO of QIAGEN."We are looking forward to developing drug-diagnostic combinations togetherwith pharmaceutical partners for the selection of the right patient for theright medicine. This concept allows cancer patients to receive bettertreatments and can support healthcare systems to provide the most usefultherapies in cost effective ways."
QIAGEN is active in more than 15 partnerships with pharmaceutical andlarge biotech companies in the field of personalized healthcare, includingAstraZeneca, Merck, Amgen, Lilly, Boehringer-Ingelheim and Pfizer. QIAGEN hasdeveloped and markets approximately 20 companion diagnostics assays inpersonalized healthcare and has a strong pipeline targeting to further expandthis leading franchise.
About Companion Diagnostics (CDx)
Companion Dx are integral to the part of personalized healthcare whichallows physicians to determine patients' potential responses to drugtreatment. These diagnostic tests are developed together with drugs forparticular populations. By testing for specific genetic variations related tocertain biomarkers, health professionals can customize their treatments toachieve the best possible therapeutic results and avoid unnecessarytreatments.
QIAGEN N.V., a Netherlands holding company, is the leading globalprovider of sample and assay technologies. Sample technologies are used toisolate and process DNA, RNA and proteins from biological samples such asblood or tissue. Assay technologies are used to make such isolatedbio-molecules visible. QIAGEN has developed and markets more than 500 sampleand assay products as well as automated solutions for such consumables. Thecompany provides its products to molecular diagnostics laboratories, academicresearchers, pharmaceutical and biotechnology companies, and applied testingcustomers for purposes such as forensics, animal or food testing andpharmaceutical process control. QIAGEN's assay technologies include one ofthe broadest panels of molecular diagnostic tests available worldwide. Thispanel includes the digene HPV Test, which is regarded as a "gold standard" intesting for high-risk types of human papillomavirus (HPV), the primary causeof cervical cancer, as well as a broad suite of solutions for infectiousdisease testing and companion diagnostics. QIAGEN employs more than 3,500people in over 30 locations worldwide. Further information about QIAGEN canbe found at http://www.qiagen.com/.
QIAGEN SAFE HARBOR STATEMENT
Statements contained in this release that are not historical facts areforward-looking statements, including statements about our products, markets,strategy and operating results. Such statements are based on currentexpectations that involve risks and uncertainties including, but not limitedto, those associated with: management of growth and international operations(including currency fluctuations and logistics), variability of our operatingresults, commercial development of our markets (including applied testing,clinical and academic research, proteomics, women's health/HPV testing,molecular diagnostics, personalized healthcare and companion diagnostics),our relationships with customers, suppliers and strategic partners,competition, changes in technology, fluctuations in demand, regulatoryrequirements, identifying, developing and producing integrated productsdifferentiated from our competitors' products, market acceptance of ourproducts, and integration of acquired technologies and businesses. Forfurther information, refer to our filings with the SEC, including our latestForm 20-F. Information in this release is as of the date of the release, andwe undertake no duty to update this information unless required by law.Contacts: Dr. Solveigh Mahler Director Investor Relations QIAGEN N.V. +49-2103-29-11710 e-mail: firstname.lastname@example.org Albert F. Fleury Director Corporate Finance and Investor Relations North America QIAGEN N.V. +1-301-944-7028 e-mail: email@example.com Dr. Thomas Theuringer Associate Director Public Relations QIAGEN GmbH +49-2103-29-11826 email: firstname.lastname@example.org Joanne Cross Marketing Manager DxS - a QIAGEN Company Phone: +44(0)7540-121-673 Email: email@example.com