Clinical laboratories running next-generation sequencing (NGS) oncology tests now have access to a universal quality control material compatible with multiple sequencing platforms. The AcroMetrix Oncology Hotspot Control provides a common quality control material that can be used across laboratories with different NGS instrument platforms, assays and bioinformatics pipelines to test precision and detect analytical deviations that may arise from reagent and instrument variation.
“Until now, clinical laboratories using next-gen sequencing for somatic mutation detection had to either rotate through previously characterized samples, with unknown content and stability, or mix their own cell line pools, which is time- and resource-intensive”
The Oncology Hotspot Control allows users to control for more than 500 hotspot mutations with a single QC control and contains cancer-associated mutations across 53 genes, including KRAS, BRAF, ERBB2, EGFR and TP53. Users can choose from 500 single nucleotide variants, 19 insertions, 29 deletions, and three complex mutations.
“Until now, clinical laboratories using next-gen sequencing for somatic mutation detection had to either rotate through previously characterized samples, with unknown content and stability, or mix their own cell line pools, which is time- and resource-intensive,” said Linh Hoang, M.D., Ph.D., director of quality controls at Thermo Fisher Scientific told Amira News. “With launch of the Acrometrix Oncology Hotspot Control, labs now have a routine quality control material that can be used for multiple assays.”
The AcroMetrix Hotspot Oncology Control was developed using innovative MegaMix Technology, a proprietary high-multiplex blending process, and contains both synthetic and genomic DNA. In performance testing across more than 30 external sites, using the technology allowed laboratories to standardize QC across multiple NGS platforms and refine their bioinformatic pipelines.
“Quality controls are an important part of a clinical laboratory’s quality assurance program, and the commercial availability of a platform-agnostic control will raise the standard for NGS in the clinical laboratory,” said Hoang.
AcroMetrix quality control materials are manufactured in cGMP facilities in accordance to ISO 13485 and follow ISO 17511:2003 for metrological traceability, which ensure lot-to-lot consistency of the control material. The AcroMetrix® Oncology Hotspot Control has a validated 18-month shelf life at -20°C and is stable over five freeze-thaw events.
The Hotspot Control will be available immediately in the United States and Europe, with availability in Australia, Japan, and other regions to follow.