A Medical Device Daily

Gene Express (Wilmington, North Carolina) reported that it has signed three definitive agreements with NeoGenomics Laboratories (Fort Myers, Florida) to license the SEM Center and StaRT-PCR (Standardized Reverse Transcription Polymerase Chain Reaction) Technology.

NeoGenomics will support Gene Express in its FDA validation of its Lung Cancer Risk Prediction and BCR/ABL tests. The agreements also will allow NeoGenomics to commercialize Gene Express diagnostic tests, validate future Gene Express technology to fulfill FDA requirements, and utilize StaRT-PCR for its own commercial activities. These agreements succeed in establishing a key validation and commercialization partnership between Gene Express and NeoGenomics.

Jonathan Rowe, PHD, senior VP of strategy and clinical innovation for Gene Express, said, "NeoGenomics provides significant experience and insight in the field of clinical molecular diagnostics as well as new assay validation, clinical trials and FDA submissions which are of great value to Gene Express. This partnership allows Gene Express to fully develop and execute its innovative pipeline with a skilled partner that is able to provide comprehensive support from validation through to commercialization of our products."

Robert Gasparini, president/CSO of NeoGenomics, said, "Gene Express has developed advanced and innovative technologies to support the diagnosis, prognosis and therapeutic response monitoring of disease. NeoGenomics, through its Clinical Trials Services division, is [pleased] to provide our expert assay validation, development and FDA submission services to Gene Express for their Lung Cancer Risk Prediction, BCR/ABL and pipeline products."

Over the next year, Gene Express will be undertaking activities to develop these genetic tests and bring them to market. Such activities will include clinical trials to validate the lung cancer risk prediction test, submission of the data to the FDA, manufacturing of a regulatory compliant standard mixture of internal standards (SMIS) for the testing of BCR/ABL gene expression, clinical trials to validate the SMIS, and clinical trials to support a regulatory approved molecular diagnostic with internal standards for BCR/ABL.

Gene Express said it intends to complete the clinical validation and submission for FDA approval of the Lung Cancer Risk Prediction test in 4Q08, and will begin clinical trials to support an FDA approved BCR/ABL test by 1Q09.

NeoGenomics Laboratories is a CLIA certified clinical reference laboratory specializing in providing cancer genetics diagnostic testing, the fastest-growing segment of the laboratory industry, to the medical device, pharmaceutical and diagnostic development industries.

Gene Express develops molecular diagnostic testing products.