Setting diagnostic standards

TUCSON, Ariz.—Starting with a $2.1 million grant from Science Foundation Arizona, the Critical Path Institute (C-Path) and Ventana Medical announced they will collaborate on the development of standards and evaluation processes for companion diagnostics aimed at cancer therapeutics. The two groups will use their respective expertise in the governmental and corporate arenas to hone the application and approval process for these key tests.

"Developing companion diagnostics is a crucial step in the evolution towards personalized medicine, replacing the current practice of one-size-fits-all therapy," says Christopher Gleeson, Ventana president and CEO. "Under the current model, many therapies are ineffective for a substantial number of patients and certain therapies can have dangerous side effects from which non-responders should be spared."

With companion diagnostics, however, patient care is more precisely tailored to individual needs, providing a measure of both safety and economic benefit.

"The award from Science Foundation Arizona will fund an important step toward making the next generation of important patient care solutions a reality," says Dr. Jeffrey Crossman, C-Path CSO and lead investigator on the project.

"The ultimate goal of the project is to guide the choice of targeted therapy so that patients receive the most effective treatments," Crossman adds.

"Companion diagnostics can also offer substantial benefits to pharmaceutical firms by potentially reducing the time of drug development, facilitating earlier and better decision-making, facilitating regulatory approval, accelerating the therapy acceptance curve, increasing revenue peak, and lengthening approved products' life cycles," Gleeson adds.

Companion diagnostics have long been a goal of the FDA, which in April 2005 released a concept paper on the subject. In discussing the paper, CDER's Dr. Felix Frueh told Drug Discovery News: "I think that the advantages of co-development…are finding the best possible strategy to have a tool ready at the time that the drug is getting approved so that you don't have any delay. It's not all that special, in that sense. It's just the coordination, the strategic approach to development in a time when perhaps it's not 100 percent certain that you have the exact biomarker."

The C-Path/Ventana project represents a step in that direction.

Within a newly formed program—US Diagnostic Standards (USDS)—C-Path will develop performance standards for companion diagnostic assays, which will then be applied within Ventana on one of its in-process lung cancer tests.

"The project represents a path towards a more predictable process to reach FDA approval where drugs and diagnostics are involved," Gleeson explains. "C-Path will be a neutral third party to help bridge the gap between commercial and regulatory needs and interests."

Ventana will then look outward and work with pharmaceutical companies to facilitate their interactions with the FDA. The company is presently working on 30 different projects with 10 drug companies regarding companion diagnostics.

The process will not be without its technical challenges, however.

"Understanding the various pathways and identifying biomarkers that may be indicated in disease has been challenging for clinical researchers and drug companies alike," Gleeson says. "From a diagnostic company perspective, inventing and developing sensitive enough detection systems for these various biomarkers has not been easy; however, over the past several years, key innovation breakthroughs have occurred in this area."