Invivoscribe has a long and proud history of international cooperation. In fact, we believe we were the first US company to initiate a relationship with our European colleagues towards standardization of molecular diagnostic testing for gene rearrangements and gene translocations. Almost a decade ago we formed an alliance with the BIOMED-2 Group (EuroClonality Group) around their outstanding work towards standardized clonality testing. Their seminal study: BIOMED-2 Concerted Action BMH4-CT98-3936 as published [Leukemia (2003) 17, 2257-2317] was followed by a second study that built on their previous work [Leukemia (2007) 21, 201-237]. Invivoscribe has secured exclusive rights to commercialize products from these clinical studies.
We are honored to be associated with this outstanding group of scientists and clinicians representing 47 institutions in seven European countries.
Even prior to this association we were pleased to secure a worldwide exclusive license to a series of patents held by Dr. Alexander Morley from Flinders Medical Centre in Bedford Park, South Australia that covered clonality testing of the antigen receptor genes. A wonderful relationship continues to this day as we continue to work with Dr. Morley and his company, MonoQuant Pty Ltd, which is based in Adelaide, Australia on techniques for minimal disease testing.
Currenly Invivoscribe and its subsidiaries are working with an international array of scientists and organizations towards development, validation and commercialization of technologies for personalized molecular diagnostics and personalized molecular medicine.
Invivoscribe embraces this more seamless cooperative spirit, an interaction between countries and groups that facilitates development of the best test for patient care. Consensus, or at least respectful understanding of differences based on the science, is important for standardization and advances in the field of personalized molecular medicine. Invivoscribe relies on a combination of our intramural resources and international collaboration with scientists and institutions to identify promising areas early. It's crucial to cipher through different pathways emerging in molecular medicine, and pursue particular leads in a targeted way to develop and commercialize tests and technologies on time so that they are available when they will be most useful to the community.
International cooperation and standardization by regulatory agencies is helpful, and movement towards standardization shows some promise, as steps have been put in place by the FDA, CAP, and CLIA here in the US, and by regulatory bodies abroad, and these groups have developed some excellent guidelines. Providing the best science-based standards with the least burdensome approach is something we all should be in favor of achieving.