ATCC SDO Releases First Standardized Consensus Protocol.

The ATCC® Standards Development Organization (ATCC SDO), an entity of ATCC, has published its first voluntary consensus standard, ASN-0001: "Standardization of In Vitro Assays to Determine Anthrax Toxin Activities."

The document is an approved American National Standard that provides recommended protocols to facilitate comparison of data among laboratories. The overall objective of this standard is to provide stakeholders with a uniform methodology for assaying the in vitro activities of the anthrax toxins, lethal toxin and edema toxin. A living document, the consensus standard will be subject to revisions over time to reflect changes in the field and new methodologies (see also American Type Culture Collection ATCC).

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.

"We are excited about releasing this new standard," said Dr. Raymond Cypess, President and Chief Executive Officer for ATCC. "It is one example of our commitment to the program mission for the ATCC SDO, which is to develop and publish stakeholder-proposed, industry-relevant standards for biomaterials and related processes. We are creating and maintaining biological standards that protect public interests," said Cypess, "and we endeavor to ensure that government, regulatory agencies, and private SDOs have the tools and resources to ensure the importance of properly authenticated material for biological research and product development."

The human anthrax cases resulting from the intentional dissemination of spores through the U.S. mail in 2001 have stimulated a substantial increase in basic and translational research conducted on Bacillus anthracis and its virulence factors, including anthrax toxins. "We are on the forefront of responding to the recognized variability in how investigators currently utilize various anthrax toxin reagents and assays and how they interpret their results," said Liz Kerrigan, Director, Standards and Certification Microbiology, Biodefense and Emerging Infectious Diseases, for ATCC.

In March of 2008, the ATCC SDO assembled a workgroup, chaired by Molly A. Hughes, M.D., Ph.D., of the University of Virginia, to develop these essential guidelines. "The standard represents a collective experience and expertise that led to a refinement and consolidation of multiple methods and protocols that should be of critical value to investigators who are working with anthrax toxins," said Dr. Hughes.

This standardization better enables investigators to compare data and to interpret the biological relevance of the effect. As recombinant protein toxins become available, an important next step is to standardize the use of the ...