HILDEN, Germany—QIAGEN has entered into four separateagreements that add multiple biomarkers and manufacturing capability to thecompany's pipeline of diagnostics for personalized healthcare applications.QIAGEN intends to develop new diagnostics to guide treatment decisions(including companion diagnostics paired with medicines) based on thesebiomarkers for use in therapeutic areas such as rheumatoid arthritis, lungcancer and colorectal cancer.
Most of these assays will be designed to run on theQIAsymphony Rotor-Gene Q (RGQ) modular laboratory workflow automation system,as well as QIAGEN's next-generation sequencing workflows currently indevelopment. RGQ is a real-time PCR cycler with a proprietaryrotary design that the company claims offers the highest reliability andquality of results dueto the more homogenoustemperature distribution in the reaction chamber.
"These new agreements add further depth to our extensivedevelopment portfolio of biomarkers with potential to provide valuablediagnostic information as well as personalized guidance for treatmentdecisions. The opportunity to create a new, improved paradigm in the importantand vast field of rheumatoid arthritis is very exciting, and the otheragreements further deepen our pipeline in oncology," says Peer M. Schatz, CEOof QIAGEN. "QIAGEN's global leadership in co-developing personalized healthcaresolutions in partnership with pharmaceutical and biotechnology companies hasbecome a key growth driver for our business. Our diagnostics are deliveringmolecular information to transform medical care for a wide range of diseases."
The four developments include a strategic equity investmentin Drug Response Dx GmbH with the option to obtain worldwide rights tobiomarkers for evaluation of rheumatoid arthritis (RA) patients to guidetreatment with TNF-alpha inhibitors, which are widely prescribed for treatmentof RA. Therapy with TNF-alpha inhibitors is successful in approximately 60 to70 percent of RA patients, but treatment failure does not become apparent forabout six months. A companion diagnostic to predict which RA patients arelikely to respond to TNF-alpha inhibitors would improve quality of life forpatients through tailored and earlier use of the most effective drugs, whilealso decreasing costs due to failed treatments.
Drug Response Dx, based in Hennigsdorf, Germany, is beingfinanced at this stage by QIAGEN and High-Tech Gründerfonds GmbH, a Germaninvestor in early-stage companies and a co-founder of Drug Response Dx, whichhas developed proprietary RA biomarkers based on technology licensed fromMax-Planck-Innovation.
In a second move, QIAGEN has agreed to license exclusiveworldwide rights from Insight Genetics Inc., a molecular diagnostics company inNashville, for the RET, ROS1 and DEPDC1 biomarkers for use in non-small celllung cancer (NSCLC), the most common form of lung cancer. Collectively, RET,ROS1 and DEPDC1 mutations are estimated to be present in up to about one in 10of all NSCLC cases, but so far there are no regulatory-approved commercialtests to reliably and efficiently identify these biomarkers. Previously, QIAGENand Insight entered a licensing and co-development partnership for companiondiagnostics focusing on the ALK gene, which several pharmaceutical companiesare targeting for new anticancer treatments. The development of the EM4-ALKassay for use on the QIAsymphony automation system is progressing well, saysDr. Thomas Theuringer, QIAGEN's director of communications. Mutations of ALKare implicated in NSCLC and other malignancies, and several compounds known asALK inhibitors are in clinical trials with one ALK inhibitor already on themarket.
Also, QIAGEN Marseille (QIAGEN's subsidiary previously knownas Ipsogen) has licensed exclusive worldwide rights to a biomarker formutations of the HSP110 gene, which allows for identification of specific typesof colorectal cancer, from Inserm Transfert, the technology transfer arm of theFrench National Institute of Health and Medical Research (INSERM) in Paris.QIAGEN intends to develop the biomarkers into a diagnostic test for routine usein the diagnostic workup of colorectal cancer patients.
Diagnosing HSP110 mutations holds promise for enablingdoctors to identify so-called microsatellite instability (MSI), which occurs inabout 15 percent of all colorectal cancers. Patients with MSI have a morefavorable outcome. On the other hand, about one-third of these patients withMSI have Lynch syndrome, an inherited form of colorectal cancer that is linkedto a higher risk of developing a second cancer. The detection of this mutationis expected to help in assessing the MSI phenotype of colorectal cancer.
Finally, QIAGEN has entered into a multiyear development andlicense agreement with IntelligentMDx under which the latter will design,develop and manufacture several undisclosed CE-marked and FDA cleareddiagnostic tests for use on QIAGEN's flagship QIAsymphony RGQ automatedplatform. The undisclosed assays being developed by IntelligentMDx are plannedto be incorporated into QIAGEN's growing menu of molecular diagnostic assaysand will be distributed by QIAGEN worldwide. QIAGEN has also retained therights to assume manufacturing of the assays pursuant to volume considerations.
Of patented versusproprietary protection
Commenting on the return of the Myriad Genetics case to the U.S. Supreme Court for review,Courtenay Brinckerhoff, a partner with Foley & Lardner LLP and vice chairof the firm's Chemical, Biotechnology & Pharmaceutical practice, notesthat, in the end, Europe may provide broader patentability. That said, shebelieves that "if the court leaves room for claims, people will continue toseek patents." But if that proves too difficult, she thinks there may be amovement to greater reliance on trade secrets.
Already QIAGEN, appears to have embarked on such a path, at least in part.
"Patents are important to incentivizethe development of innovative gene-based diagnostics," says Dr. ThomasTheuringer, the company's PR director. "However, they are a not decisive forQIAGEN's business model," he quickly adds. "We run a product business, not aservice business, and we make all of our products available to researchers andpatients worldwide within their given license restrictions. The competitiveenvironment in fields QIAGEN is focusing on, such as personalized healthcare,is shaped by factors such as partnerships, regulatory and reimbursement regimesand access to samples, not only by intellectual properties.
"Comparedwith Myriad's patents on BRCA1 and 2, the IP landscape for biomarkers can bemore complex," Theuringer adds."Take KRAS, for example, involving claims from Genentech, Johns Hopkins,Genzyme, Amgen and others, and applying to different mutations, indications anddrug targets. We vigorously defend our patents."