Back To: Home : Featured Technology : Functional Genomic Screening
|
Choosing controls
January 2014
EDIT CONNECT
SHARING OPTIONS:
MANASSAS, Va.—The use of well-defined
controls in assay development is essential for determining the reliability and reproducibility of data obtained from molecular applications. ATCC, which claims to have the world’s largest and most diverse collection of human, animal and plant
cell lines, molecular genomic tools, microorganisms and biological products, spoke out on this topic during its first participation at the Corporate Workshop
Day at the Association for Molecular Pathology (AMP) 2013 Annual Meeting, emphasizing the importance of
using authenticated and highly characterized biomaterials for assay development and verification.
More than 75 researchers
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.
Liz Kerrigan, director of standards at ATCC explains, “Next-generation sequencing has led to the
genomic age, and the cost of sequencing the genome is falling. Large-scale sequencing programs are looking at mutations and target drugs and seeing the
resistance.”
Kerrigan describes the challenges in molecular diagnostics as ‘omics data storage, data
analysis, clinical quality standards for each step from sample to answer and appropriate and reliable controls. Although more than 1,900 genetic tests are
available, the majority of tests still need characterized references or quality-control materials, she said.
Kerrigan explains that the need for molecular-based tests has increased significantly in the last few years, stimulated by the discovery of new
hereditary genetic disease loci (biomarkers) following the completion of the Human Genome Project and by “the presence of emerging and reemerging
microbial threats such as SARS, H1N1 and multidrug-resistant organisms such as TB.” She added that molecular assays provide several advantages,
including increased specificity, sensitivity, rapid detection and identification of outbreaks, and can be used in oncology, infectious disease and genetic
testing.
“As nucleic acids become major targets for analysis in clinical laboratories, the need for
standardization is critical,” Kerrigan says. “Standards are needed to establish sensitivity, linearity and specificity during assay validation or
implementation, quality assurance, quality control and proficiency testing.”
Kerrigan adds that standards
are meant to improve reproducibility. The incorporation of standardized biological materials generates meaningful data that can be compared within or to
other laboratories around the world. “Efficiency, reliability and reproducibility are critical factors when funding and resources are limited,”
she says, adding that the development of biological standards for molecular testing promotes assay development, automation and third-party reimbursement for
clinical testing.
“There are a lot of choices for controls in research, but it’s imperative to obtain
controls from a reliable source; knowing how they were produced and how identities were verified,” Kerrigan insists. “That’s the importance
of authentication.”
She went on to describe how ATCC maintains a rigorous quality-control program under
ISO/IEC 17025, ensuring the identity and purity of biological materials. Cultures housed within the ATCC repository are managed under a seed stock banking
concept, which limits passage and allows for strict quality-control testing to be performed on both seed and distribution materials. 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 profiles.
As the tools available to laboratories change, ATCC is
adapting to make it easier for investigators to locate genetic and phenotypic data related to the controls they need 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.
Kerrigan concludes that next-generation sequencing is revolutionizing medical
research and has the potential to be a powerful diagnostic tool for cancer. She says that challenges still remain, including areas of technical,
computational, data interoperation, standards and certified reference materials. She believes that “authenticated cell lines and validated genetic
alteration cell panels could be useful tools and controls in molecular diagnostic testing.”
Code: E011422 Back |
|||||||
|
|
Home |
FAQs |
Search |
Submit News Release |
Site Map |
About Us |
Advertising |
Resources |
Contact Us |
Terms & Conditions |
Privacy Policy
|
© Copyright 2019 Old River Publications LLC. All righs reserved. | Web site managed and designed by OffWhite.