Pressure BioSciences, Inc. (PBI) and California-based private company, Target Discovery Inc. (TDI), have expanded strategic technology licence and supply agreements.

Under these agreements, TDI now has the right to use PBI’s patented and enabling Pressure Cycling Technology (PCT) Platform for their planned entry into the clinical diagnostics testing market.

The planned commercial diagnostic services will initially target what the companies believe are critical, unmet needs in treatment selection guidance for ovarian cancer. Until now, PBI’s PCT Platform has been available on a “research-use-only” basis.

In 2010, the companies announced a collaboration to combine PBI’s PCT Platform with TDI’s proprietary reagents to enable the extraction of membrane protein biomarkers from human tissue. Such biomarkers include specific modified proteins (“isoforms”) that have heretofore been very difficult to extract from tissue in a form suitable for diagnostic testing. The companies believe that the ability to rapidly extract and recover diagnostically and commercially useable protein isoforms from cell membranes is unique to PCT and the TDI reagents, and that this capability positions the companies with game-changing abilities to exploit this critical class of membrane proteins as diagnostic biomarkers.

Jeffrey N Peterson, CEO of TDI, and a director of PBI, said, “We are very pleased with the progress and outcomes achieved in our on-going multi-year collaboration with PBI. We believe that the PCT Platform, in combination with TDI’s proprietary reagents, provides reliable access to this important class of protein biomarkers for life sciences R&D. We further believe that variations measured in these protein isoforms are expected to translate into important commercial applications, and desperately needed breakthroughs in improved patient care and health-economic outcomes. Our first area of application focus is in ovarian cancer, where over 22,000 women are diagnosed annually in the USA with this fast-moving disease, and over two-thirds of these new patients could be helped dramatically by the introduction of reliable treatment selection guidance diagnostic information.”

Membrane proteins play key biological roles in cancer, in drug resistance, and in viral infections, yet until now scientists have been virtually unable to use this important class of biomarkers for diagnostic and prognostic testing,” commented Dr Luke V Schneider, TDI’s chief scientific officer. “These proteins are tightly bound within the cell membrane, making them very difficult to extract and recover for scientific study. The extraction of membrane proteins from tissue samples typically requires the use of aggressive physical and chemical methods that yield useless protein fragments, often in solutions that are completely incompatible for laboratory testing. Consequently, although membrane proteins and their isoforms play vital roles in human health and disease, they have never been conveniently available for use as disease biomarkers.”

Richard T Schumacher, CEO of PBI, remarked: “The innovative scientific team at TDI has vaulted important anticipated applications for PCT forward into near-term realities. The power and impact of TDI’s isoform-focused technologies and their promise in opening a new era in personalized medicine diagnostics for cancer treatment is dramatic and inspiring. We are excited that PBI’s patented PCT Platform will provide the sample-processing foundation upon which many of TDI’s next generation clinical laboratory testing services will be based, and we look forward to supporting our colleagues at TDI with our continued collaboration, and by fulfilling their expected PCT Platform instrument and consumables needs.”

The non-exclusive, worldwide, royalty-bearing licence is for the in vitro diagnostic services testing for the detection of proteins that may be regarded as biomarkers of ovarian and other cancers, including any number of specific or all protein isoforms. The license agreement includes a minimum royalty that is replaced by an annual royalty once TDI achieves a specified minimum level of diagnostic testing sales. It also includes a right of first negotiation and right of first refusal for an exclusive license to sell biomarker and/or diagnostic assay products, including instruments, software, kits and consumables, in a specified field of use. The licence continues for the life of PBI’s PCT patents. Under the Supply Agreement, PBI will make available to TDI the PCT instruments and consumables required at “most favored nation” pricing.

TDI, is developing the next generation of clinical diagnostics, offering higher-value molecular insights for disease management and diagnosis.

PBI is focused on the development, marketing, and sale of proprietary laboratory instrumentation and associated consumables based on Pressure Cycling Technology (PCT).