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Critical X Solutions

Brief Description

Critical X is a research and development service laboratory providing rapid and reliable tissue-based study design and execution to the biomedical research community. Our service offerings incorporate advanced histologic methods as well our proprietary Cx Array technology; a microscope slide-free approach for multiplexed testing on tissue sections. This technology has the potential to replace the microscope slide as the testing vessel of choice for many of today’s tissue-based assays.

Mission

Critical X has as its primary mission to raise the quality and efficiency of tissue-based biomarker assays by providing a platform that, unlike current microscope slide-based approaches, controls key assay variables and increases throughput while preserving the contextual information required for pathologic evaluation, diagnosis, and/or therapeutic biomarker assessments.

Technology and Systems

Our technology transfers advanced histologic staining techniques performed on routinely processed tissues (e.g. Immunohistochemistry and/or in situ hybridization) onto a multi-well format. This platform enhances multiplex capabilities and provides greater control of assay variables through liquid handler mediated automation and integration with automated image analysis systems. The platform is also compatible with downstream molecular workflows.

Business Strategy

The overall business strategy will be 2 phased:

Phase 1. Services - Pre-clinical and clinical research services where specimens are sent our laboratory for preparation, testing, and analysis. Microscope slide-based services will also be made available.

Phase 2. Medical Device Platform – A medical device platform with associated reagents and consumables will be developed. As an advanced in situ assay platform, the development of FDA 510(k) approved assay kits for companion/complementary diagnostics (e.g. PD-L1) based on knowledge and intellectual property obtained in Phase 1 will be a key strategic imperative.

Market

The Total Addressable Market (TAM) is a sub-segment of the Tissue and Cell Diagnostic Market covering in vitro diagnostic testing and associated instruments and reagents. This market is currently valued at $7.4B and is expected to grow to $9.5B by 2018. The Serviceable Available Market (SAM) for Critical X in the United States is currently $1.1B and expected to grow to $1.7B by 2018 and covers in situ hybridization, immunohistochemistry, digital pathology, image cytometry, circulating tumor cells and oncology testing.

The research component of this market is dynamic and thus difficult to define by market analysts; however, this market is considered larger and growing more rapidly due to a strong emphasis on biomarker discovery in support of targeted therapies (Kalorama Information, LLC).

Management

Carlos Genty, inventor and experienced laboratory director with expertise in research and clinical histochemistry, high volume laboratory operations management, and laboratory information systems.

Timothy McDonnell, M.D., Ph.D., consultant, key advisor, professor, physician, and scientist with expertise in anatomic pathology, hematopathology, and research - leveraging in vitro and in situ molecular biology techniques on patient material, cell lines, and genetically engineered strains of mice.