Products



Overview
Genes to Antibodies
Clinical Development
Future Antibody Pipeline

 

 

 



AGI's approach is to use our tissue-tailored Panel of Diversity reagents to stain large patient cohorts in order reveal significant biologic variation. Correlative science is then used to identify patient tumor subtypes associated with clinical outcome. The discovery and validation of clinical biomarkers requires an iterative approach that narrows and focuses discovery and validation studies in order generate robust statistics in support of the clinical use of novel biomarker panels.









For example, AGI's Mammostrat test was initially discovered in a study in which we applied the breast 'Panel of Diversity' to a 550 patient cohort of breast cancer specimens from the Clearview Cancer Institute of Huntsville, AL. AGI first assessed the association of each antibody individually with clinical outcome in the ER+ and ER+ node negative patient subsets. Statistical analysis was used to nominate prognostic models that minimized the number of biomarkers needed to predict outcome. A set of five antibodies combined using a Cox proportional hazard model was nominated as the favored model. This test, initially using polyclonal antibodies, was then validated in two independent studies. A second generation monoclonal version of the test was then subsequently validated in two additional studies. For more information on Mammostrat and the test's validation studies, please go to either Mammostrat Overview or Mammostrat Development and Validation.

Similarly, Pulmostrat, AGI's lung prognostic test, is currently in the validation phase of development. An early stage NSCLC cancer cohort obtained from the Clearview Cancer Institute of Huntsville was stained with AGI's Lung Panel of Diversity. Biomarkers associated with tumor recurrence in either lung adenocarcinoma or squamous cell carcinoma were identified and a set of seven antibodies combined using a proportional hazard model was nominated to predict risk of tumor recurrence. A second generation monoclonal test has now been validated on an independent clinical cohort (IASLC 2006 or ASCO 2005 oral presentation) and further validation studies are planned.