Brief DescriptionCritical X is a research and development service laboratory and consumables supplier providing rapid and reliable tissue-based tools to the biomedical research community. Our service offerings incorporate advanced histologic methods as well our proprietary Flex-Array technology; a multi-well device for multiplexed semi-quantitative testing of intact tissue sections. This technology has the potential to replace the traditional microscope slide as the testing vessel of choice for many of today’s tissue-based discovery and therapeutic biomarker assays.
MissionCritical X has as its primary mission to raise the quality and efficiency of tissue-based biomarker testing by providing a platform that, unlike traditional slide approaches, controls key assay variables and increases throughput - all while preserving the contextual information required for research pathologic evaluation, diagnosis, and/or therapeutic biomarker assessments.
Technology and SystemsOur technology transfers and elevates advanced histologic staining techniques performed on routinely processed tissues through a multi-well formatted device. The platform enhances multiplex capabilities and provides greater control of assay variables (with our without liquid handler mediated automation) for integration with automated ELISA-like readers, image analysis systems, and/or downstream molecular workflows at fraction of the cost of currently available systems.
Business StrategyServices - Pre-clinical and clinical research services where specimens are sent our laboratory by Key Opinion Leader (KOL) customers and early adopters for preparation, testing, and analysis.
Medical Device Platform - A multi-well medical device with associated reagents and consumables are close to commercialization for research use only. As an advanced in situ assay platform, the development of FDA approved assay kits for companion/complementary diagnostics, serving multiple indications in cancer, will be a key strategic imperative. Our intellectual property, team expertise, and insights obtained through KOL collaborations, will be key differentiators in our market.
MarketThe 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 $4.7B and is expected to grow to $6.9B by 2022 according to Frost & Sullivan. The Serviceable Available Market (SAM) for Critical X in the United States is expected to grow at a healthy 12% CAGR reaching $700M by 2021 - its scope and focus is digital pathology automation products.
According to Kalorama Information research is a another segment outside of the markets noted above, but considered to be more dynamic and thus difficult to define; however, this market is considered larger and growing more rapidly due to a strong emphasis on biomarker discovery in support of targeted therapies.
ManagementCarlos Genty, BS, HT(ASCP)QIHC, LSSBB. Inventor and experienced laboratory director with expertise in research and clinical immunohistochemistry, in situ hybridization, esoteric assay development, high volume laboratory operations, Lean Six Sigma process controls, and laboratory information systems.
Timothy McDonnell, M.D., Ph.D. Chief Scientific Officer, professor, physician, and scientist with expertise in anatomic pathology, hematopathology, as well as basic and translational research - leveraging in vitro and in situ molecular biology techniques on patient material, cell lines, and genetically engineered strains of mice.
Miguel Angel Garza, , CG(ASCP), MBA, MS. Chief Operation Officer and medical laboratory scientist with 12 years of experience in esoteric clinical and research laboratory organizations. Mr. Garza is experienced in high complexity testing, assay development, operations, and quality systems and has held leadership roles in CRO and CMO environments.