Product DevelopmentOur Process We operate what we believe is the world’s most advanced biomarker discovery platform, which is outlined below.Discovery This phase starts with identifying an unmet clinical need and product opportunity. A target product profile is then developed to guide the discovery and development process and support stage-gate decisions. In this phase, we apply our proprietary technology platform on a large scale to discover and validate novel biomarkers that may be used for developing novel diagnostic tests.Development The development process is designed to be consistent with industry standards and practices. This stage includes the development and optimization of an assay and acquisition of suitable specimens and data from appropriate clinical studies for the endpoints to support the targeted claims. As part of this process, we also seek appropriate institutional review board or ethical committee approval. Finally, clinical samples are tested using the assay and the clinical data is analyzed. The final stage of this process involves preparation and submission of the appropriate regulatory documents.Launch Prior to the launch of a product, we plan to contract with third-party manufacturers for our in vitro diagnostic kits or laboratory service providers for our regulated laboratory service, and commence the transfer of technology and validation in preparation for commercial product introduction.Automated Assay Format Development |