Two ways about it

HILDEN, Germany—At the end of May, QIAGEN NV let the worldknow it got a boost to its pipeline of promising new biomarkers when itannounced two new agreements, one with Columbia University and the other withthe British Columbia Cancer Agency. Together they bring promising newbiomarkers involving glioblastoma, lymphoma and other cancers to QIAGEN'sexpanding portfolio of potential companion diagnostic (CDx) products.

For the glioblastoma part of things, QIAGEN entered into anexclusive worldwide licensing option on FGFR-TACC fusion genes with ColumbiaUniversity in New York. QIAGEN notes that it intends to develop this biomarkerinto a diagnostic test for routine use in diagnostic workups, which may enabledoctors to identify glioblastoma patients who could benefit from targetedtreatments now under development. Fusions between members of the FGFR and TACCgene families also have been identified recently as present in several othermalignancies, including bladder cancers.

On the more lymphoma-oriented side of the equation is anexclusive license option with the British Columbia Cancer Agency, based inVancouver, for the EZH2 Y641 mutation biomarker that could serve as a CDx testfor routine selection of patients who could benefit from EZH2 targetedtherapies that are currently under development by major pharmaceuticalcompanies.

"While we know EZH2 is involved in certain types of breastand prostate cancer, it has never before been found mutated in any cancer andwas not previously implicated in having a role in lymphomas," said Dr. JosephConnors of the British Columbia Cancer Agency in 2010 when the agency announcedits findings about EZH2. "The presence of this mutation can be considered amarker that will aid in diagnosing these lymphomas and identifying newtherapies for their treatment."

Noting that expanding its portfolio of biomarkers for thedevelopment of innovative CDx options is a key focus of his company and thatpersonalized healthcare is "driving the growth of QIAGEN as molecularinformation plays an increasingly important role in improving outcomes forpatients," QIAGEN CEO Peer M. Schatz has noted that "QIAGEN's expertise andsolutions spanning the continuum from research to commercialization is drivingsignificant value in personalized healthcare, a rapidly growing franchise with$100 million of annual sales. Deep relationships with leading academic centersprovide a rich source of biomarkers, as in these latest two agreements.

In partnership with top pharmaceutical companies, we aretranslating genomic discoveries into standardized companion diagnostics toguide the use of targeted drugs."QIAGEN reached out to the British Columbia Cancer Agency inJanuary 2012 initially, recalls James Schlosser, the agency's businessdevelopment and contracts officer, and he also tells DDNEWS that the agency and QIAGEN have had previous dealings.

"A deal like this gives us the ability to not only come backto the clinic and aid and abet ourselves and our own ability to designtechnologies and processes, but also to reach out, go out and help othercenters like ours do better," adds Dr. Sam Abraham, vice president of researchat the British Columbia Cancer Agency's Research Centre. "We've done deals likethis several times in the past, because it is part of our mandate to getfinancing and development from outside to help us better use our ideas anddevelop them into products that can be used clinically."

Likewise, QIAGEN approached Columbia University, notes PeterGolikov, senior technology licensing officer at Columbia Technology Ventures,who says the company approached one of the university's inventors/researchers"shortly after the story on the significance of FGFR-TACC mutations came out inScience on Sept. 7," describing how themutation occurs in a sub-population in brain cancer patients and howmechanistically, the mutation leads to a transformed cancer cell.

"Brain cancer has a significant mortality rate even with theconventional treatments that include surgical resection, radiation and drugtherapies approved by the FDA," Golikov tells DDNEWS. "The identification of a specific treatment forthis mutation introduces the idea of using personalized medicine tospecifically target a causal mutation in the tumor cells and hopefully reducemortality. The timing of the agreement to develop the diagnostic is related to both the recent discovery and thecurrent development efforts by several companies. The clinical developmenteffort in the pharmaceutical industry drives the need for a companiondiagnostic."

QIAGEN and China's BioBAY open translational medicinecenter to accelerate CDx

SUZHOU, China—QIAGEN NV also announced last month, alongwith SIP Biotech Development Co. Ltd. (BioBAY), the opening of QIAGEN (Suzhou)Translational Medicine Center, a translational medicine company that aims toaccelerate the discovery and validation of biomarkers and to create companiondiagnostics for the Chinese market.

QIAGEN (Suzhou) is a joint venture of QIAGEN and BioBAY, theinnovative life-science cluster in Suzhou Industrial Park near Shanghai. Thecompanies announced the launch of QIAGEN (Suzhou) on the BioBAY campus, whichcurrently hosts more than 330 companies and research groups.

QIAGEN (Suzhou) will provide services and consulting withstate-of-the-art QIAGEN molecular technologies for international and Chinesepharmaceutical companies, as well as research institutes to enabletranslational medicine, the multidisciplinary process of advancing discoveriesfrom laboratory bench to the patient's bedside. The center will work withpartners located at BioBAY and elsewhere in China to provide fully integratedbiomarker solutions to accelerate drug development, as well as to commercializecompanion diagnostics. The four key service sections include biobanking,pharmacogenetics, next-generation sequencing and pharmacogenomics. QIAGEN(Suzhou) is expected to grow to about 50 employees within three years.

"We are delighted to join with BioBAY, a strategicallypositioned biotechnology partner, in the mission of creating novel moleculardiagnostics to meet pressing medical needs for patients. QIAGEN continues toexpand our relationships in China, one of our most important countries in salesand a key growth market for us," said Dr. Victor Shi, president of QIAGEN AsiaPacific, in a statement. "Partnering with BioBAY expands our commitment totranslational research in biomarkers and companion diagnostics for China andother markets. Pharma and biotech companies in China's dynamic market facespecial needs that we can address through this unique translational medicinecollaboration, helping to accelerate the development of companion diagnostics.Personalized healthcare matches important new drugs with the right patients andcreates better treatment benefits."