ATCC SDO Releases Ground-Breaking Standard for Human Cell Lines

MANASSAS, Va.--(BUSINESS WIRE)-- The ATCC® Standards Development Organization (ATCC SDO), an entity of ATCC, has published its second voluntary consensus standard, ASN-0002: “Authentication of Human Cell Lines: Standardization of STR Profiling.” This consensus standard is expected to have broad impact across basic cell research, drug discovery, and translational medicine.

This approved American National Standard represents a major step forward in correcting the long standing problem of cell line misidentification. The standard’s intent is to delineate a standardized, universally applicable method for authenticating new and established human cell lines and human primary tissue used in research. A living document, the standard will be subject to revisions over time to reflect changes in the field and new methodologies.

“This new standard is one example of our commitment to the program mission for the ATCC SDO---to develop and publish stakeholder-proposed, industry-relevant standards for biomaterials and related processes,” said Raymond Cypess, DVM, PhD, Chief Executive Officer for ATCC. “We are creating and maintaining biological standards that protect public interests,” said Dr. Cypess, “and we endeavor to ensure that government, regulatory agencies, industry and academia have the tools and resources to ensure the importance of properly authenticated material for biological research and product development.”

Human cell lines are used in research and development as models of normal and cancer tissues. However, a significant proportion of cell lines are misidentified, as a result of contamination or poor laboratory techniques and practices. The consequences of using misidentified cell lines have included the retraction of published papers and the inability to reproduce research results when incorrect cell lines are used, both of which leads to a waste of resources in support of research. The publication of the standard for the authentication of human cell lines using STR profiling represents an important step in the remediation of this problem. “ATCC has been at the nexus of responding to the recognized problem of cell line misidentification, delivering standardized methods that can be used to test cell lines throughout a research study,” said Brian A. Pollok, PhD, President of ATCC.

An international workgroup of scientists representing academia, regulatory agencies, major cell repositories, government agencies and industry, chaired by John R. W. Masters, PhD, of University College London, and Yvonne A. Reid, PhD, of ATCC, worked together to develop the standard. “The standard represents a collective experience and expertise that led to a refinement and consolidation of methods that should be of critical value to investigators who are working with human cell lines,” said Dr. Masters.

Standardization fosters the reproducibility and comparability of research employing human cells, leading to a marked decrease in the misidentification of human cells used by the scientific community. “The most important aspects of the standard are the discussions on the numbers and types of loci to be evaluated, quality control of the data, interpretation of the results (matching criteria, loss of alleles, etc.), and implementation of an STR database,” said Dr. Reid.

In 2007, the ATCC SDO became the first biological resource organization to become accredited by the American National Standards Institute (ANSI) as a standards developing organization (SDO). Accreditation by ANSI signifies that the procedures used by the SDO in connection with the development of American National Standards meet the Institute’s essential requirements for openness, balance, consensus and due process. For more information, visit http://www.atccsdo.org, phone 800-638-6597, or email to standards@atcc.org. To order the ASN-0002 Standard, visit the ANSI eStandards Store at webstore.ansi.org. To join the ATCC Standards Development Organization, please email standards@atcc.org.

ABOUT ATCC

Founded in 1925, ATCC is a global not-for-profit bioresource center and research organization that provides biological products, technical services and educational programs to private industry, government and academic organizations around the world. ATCC has demonstrated compliance with ISO 9001:2000, ISO 17025:2005, and ISO Guide 34:2000, the three most valuable attestations of quality for standards manufacturers.

ISO 9001:2000 is a widely known multi-industry international standard for quality management systems. Certification to ISO 17025:2005 attests that ATCC is consistently proficient in testing the quality of its products. And for its biological material production and testing processes, ATCC achieved accreditation to ISO Guide 34:2000, an international multi-industry standard specifically designed for producers of reference materials. The scope of the ATCC ISO Guide 34 accreditation, which extends across a wide range of the organization's processes for biomaterial production, is unprecedented in the biological sciences.

ABOUT THE ATCC®STANDARDS DEVELOPMENT ORGANIZATION

The ATCC Standards Development Organization (SDO) is a developer and publisher of stakeholder-proposed, industry-relevant, national consensus standards for biomaterials and related processes. The ATCC SDO is accredited by the American National Standards Institute (ANSI).

ABOUT THE AMERICAN NATIONAL STANDARDS INSTITUTE

As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment. ANSI coordinates development and use of voluntary consensus standards in the U.S. and represents the needs and views of U.S. stakeholders in standardization forums around the globe.

For more information, visit http://www.atcc.org.

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ATCC SDO Releases Ground-Breaking Standard for Human Cell Lines