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The Value of ATCC Biological and Molecular Standards in Assay Development

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ATCC is among the world’s leading biological resource centers, supporting both the academic and commercial research and development communities. The organization houses and supplies a wide range of biological materials and research tools, including continuous cell lines, primary cells, and hTERT-immortalized cell lines, as well as bacteria, viruses, fungi, and protists. In addition, ATCC develops and supplies microbial and tumor cell panels, certified reference materials, culture media and sera, and other research materials. This module examines the use of ATCC materials in two areas: molecular-based assays for cancer detection and analysis; and assay development for infectious diseases.

Genetic sequencing advances and molecular diagnostics are fostering the development of personalized medicine research and care. This has amplified the need for reliable biological certified reference materials for use as controls in cancer research and elsewhere. ATCC has developed a host of research materials, including authenticated cell lines and cell derivatives to support molecular-based assay development. Examples include cell lines with well-characterized mutations relevant to cancer study and purified genomic DNA preparations with key oncological biomarkers.

Several key aspects of infectious disease assay development are aided by well-characterized and authenticated biological materials. These assay-development activities include sourcing organisms with known traits and relevant genes, establishing inclusivity/exclusivity parameters, and determining sensitivity and limits of detection. The ATCC portfolio contains an extensive collection of microbial cultures and genetic material designed to support assay development in infectious disease and public health research. Among the tools are microbial cultures of known source of isolation, fully sequenced strains, cultures with clinically relevant phenotypic characteristics, and synthetic nucleic acids with clinically relevant gene sequences. ATCC also holds cultures grouped by toxin production, serotype, and drug-resistance. All of these materials and tools are developed and handled in conditions that have been certified and accredited to four relevant ISO standards.

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