For the discovery, validation, and clinical application of prognostic and drug response signatures Signature Diagnostics offers several products to its clinical and potential corporate partners:

 

sigDISCOVERY

This product consists of several technology platforms:

1. Tissue collection platform;
   
2. Array-based discovery platform;
   
3. Molecular pathology validation platform;
   
4. Protein sub-localisation platform.

Access to cohorts of well-controlled cancer patients recruited for clinical trials and snap-frozen tumor tissues obtained from surgery or biopsies are needed for such collaborations. This access will be provided by our clinical partners as well as by our corporate partner.

The tissue collection platform will be applied to collect hundreds, or even thousands of tumor tissue samples, as well as blood samples from cancer patients who have been recruited to multicentre clinical phase II and III trials. The logistics and processes within this platform are well defined to ensure that large numbers of snap frozen tumor samples of high quality and suitable for array-based studies can be collected day by day and year by year from many different hospitals throughout a local region, Germany and Europe. The platform also includes the pathological assessment of all tumor samples, the confirmation of classification and grading of all tumor samples, as well as the selection of tumor segments for subsequent array analyses. The strong pathology elements of this platform ensure rigid quality control of all tissue samples.

The array-based discovery platform will be used for the discovery of the first molecular signature in phase II or in phase III clinical trials towards a novel oncology drug or drug combination from the pharmaceutical partner. Typically, this involves 50-100 patients in phase II clinical trials, or between 500-2000 patients in phase III clinical trials.

The molecular pathology validation platform is tightly linked to the array-based discovery platform. It will be used to validate all, or selected elements, of a molecular drug response signature on the DNA, RNA, or protein level.

The protein sub-localization platform will analyze sub-cellular localization of individual tumor-specific or pathway-specific marker proteins using immunohistochemistry (IHC). This additional information will be used to differentiate more precisely between the subgroups of responders and non-responders with the aim of obtaining highly specific response signatures.