A ‘sea change’ in the desert

PHOENIX—The Translational Genomics Research Institute (TGen)and Tucson, Ariz.-based Ventana Medical Systems Inc. are taking advantage oftheir relatively neighboring locations and combining their skills in acollaborative research effort announced this summer to discover and developdiagnostic markers for treating cancer. As the two organizations put it intheir news release, two of "Arizona's premier biomedical institutions … willleverage each other's expertise in discovery and diagnostic productdevelopment, bringing innovative cancer diagnostic tests to patients."

The two parties are set for the first project under theumbrella research agreement to focus on diagnostic, prognostic and drugbiomarkers for pancreatic cancer, the fourth-leading cause of death from cancerin the United States. This year, they note, an estimated 45,000 people will bediagnosed with the disease, and more than 38,000 patients will die from it.Across the globe, some 213,000 are diagnosed with pancreatic cancer each year,and, they say, "the numbers are growing. Fewer than one in four pancreaticcancer patients survive more than a year, and fewer than 6 percent survive morethan five years—the worst survival rate of any cancer."

The reason for this "dismal picture of pancreatic cancer,"as they call it, is mainly due to the lack of tools for early detection and theineffectiveness of current therapeutics.

This is why new diagnostic markers and more efficacioustherapies are desperately needed, points out Mara G. Aspinall, president ofVentana, which is a member of the Roche Group.

"Why is this the right time for TGen and Ventana to do this?From a certain point of view, it's because of the acknowledgement from pharmacompanies and regulatory agencies that companion diagnostics, which have beenon the rise in recent years, are not simply nice to have, but absolutelynecessary to have," she tells DDNEWS."We've really expanded out our companion diagnostic efforts and with thegrowing urgency from pharmas and agencies to get these discovered and validatedand ready for clinics, it has compelled us to go find the very bestresearchers. We have a fantastic team but we recognize we cannot do it allourselves, and so that has pushed us to be more aggressive in partnering withgreat organizations like TGen."

"The requirements that we have for meeting FDA expectationsand to work with investigational agents—and the way it all carries into thearea of genomic profiling—means that we have to be integrated," adds Dr.Jeffrey Trent, TGen's president and research director. "More and more, you needtrials that combine the genomics and the investigational agents. There's no wayaround it, and the best way to do it is closer partnerships between academicand nonprofit research groups and industry to get more meaningful data out ofthese studies all the way around."

The timing of the deal isn't just about market forces, Trentsays, but also "aligning well with regulatory actors that can help us succeedor not."

And, Aspinall adds, aside from the "major sea change fromonly five years ago" in terms of positive attitudes toward companiondiagnostics, it doesn't hurt that the drive between the TGen and Ventanacampuses is relatively short, so they can work together more directly, moreeffectively and more quickly.

Ventana designs and manufactures instruments and reagentsthat automate tissue processing and slide staining for cancer diagnostics, andits solutions are used in clinical histology and drug development researchlaboratories worldwide. The company says that its intuitive, integratedstaining, workflow management platforms and digital pathology solutionsoptimize laboratory efficiencies to reduce errors, support diagnosis and informtreatment decisions for anatomic pathology professionals.

"When a patient is faced with cancer, getting an accuratediagnosis quickly is the most important part of their treatment," Aspinall saidof her company and the collaboration in the news release about the deal. "Asthe global leader in tissue-based cancer diagnostics, our strength is movingresearch into the clinic in order to improve the lives of all patientsafflicted with cancer. We are thrilled to be able to pursue this with a partnerright in our Arizona backyard."

For its part, TGen is a nonprofit organization focused onhelping patients with neurological disorders, cancer and diabetes throughtranslational research, with TGen physicians and scientists working to unravelthe genetic components of both common and rare complex diseases in adults andchildren.

"TGen is on the cutting edge of translational research,where investigators discover the genetic components of disease," Trent noted inthe news release. "Our goal is to rapidly translate basic research findingsinto actionable targets. Partnering with Ventana, we hope, will accelerate ourgoal to deliver meaningful discoveries to cancer patients today."