Importance of High-Quality Controls in Assay Design and Development Examined

The use of well-defined biological controls in assay development as essential for determining the reliability and reproducibility of data obtained from molecular applications was examined in depth at a workshop during the AMP 2013 Annual Meeting.

The American Type Culture Collection (ATCC; Manassas, VA, USA) spoke on this topic during its first participation at the Corporate Workshop Day of the 2013 (November) annual meeting of the Association for Molecular Pathology (Phoenix, AZ, USA). Emphasis was on the importance of using authenticated and highly characterized biomaterials for assay development and verification. Over 75 representatives from pharmaceutical and molecular diagnostics companies attended the workshop. The presentation was divided into two parts, first focusing on controls for genetic mutations in cancer biology, followed by a discussion on the detailed characterization of ATCC infectious disease strains and nucleic acid controls.

Fang Tian, PhD, Lead Scientist for ATCC Cell Systems, led the discussion by describing the rapidly changing landscape of diagnostics, including the vast amount of human genetic data currently available via open-access. Moreover, with the development of smaller, faster, and more affordable sequencing technologies, investigators now require a stable and renewable source of controls, such as fully characterized and authenticated cell lines. To meet these needs, ATCC organized Tumor Cell Panels representing cell lines grouped by tissue type and annotated with published gene mutation data. Further, Dr. Tian explained, “ATCC is not only pairing cell lines with published gene mutation data, we are also performing extensive laboratory analyses to confirm the presence, stability, and expression of genetic mutations using tools like sequencing, PCR [polymerase chain reaction], and Western Blot.”

Liz Kerrigan, Director of Standards at ATCC noted, “it’s imperative to obtain controls from a reliable source; knowing how they were produced and how identities were verified—that’s the importance of authentication.” In addition to providing supplementary testing for tumor cell lines, ATCC also performs extensive analyses on geographically diverse infectious disease isolates to determine serotype, toxinotype, and multidrug-resistance (MDR) profiles.

As the tools available to laboratories change, ATCC is adapting to make it easier to locate genetic and phenotypic data related to the controls needed to challenge assay design and verify results. ATCC offers a growing list of Tumor Cell Panels, Genetic Alteration Panels, infectious disease and multidrug-resistant strains, synthetic and native nucleic acids, and Certified Reference Materials (CRM)—including the newest KRAS-mutation CRMs—for assay development, inclusivity/exclusivity testing, and Limits of Detection (LOD).

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American Type Culture Collection (ATCC)