News
17-February 2012 – LGC
Standards announces ATCC SDO release of ground-breaking standards
for human cell lines
New standard will help correct cell line
misidentification
LGC
Standards, Europe’s leading supplier of reference materials and
exclusive European distributor for ATCC products, is pleased to
announce the publication of a new consensus standard for cell line
authentication.
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
standardised, 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 endeavour 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 recognised problem of cell line
misidentification, delivering standardised methods that can be used
to test cell lines early and often,” said Brian 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.
Standardisation 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 organisation
(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
www.atccsdo.org, phone
703-365-2700, or e-mail 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.
For further information on the ASN-0002 Standard, e-mail
atcc@lgcstandards.com or
tel: +44 (0)20 8943 8489.
- Ends-
Notes to editors
ABOUT ATCC
Founded in 1925, ATCC is a global not-for-profit bioresource centre
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
organisation'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 standardisation forums
around the globe.