Thermo Fisher Scientific launches clinical next-generation sequencing oncology quality control

Thermo Fisher has made the AcroMetrix Oncology Hotspot Control available to customers in the United States and Europe. This product provides a common quality control material that can be used across laboratories with different next-generation sequencing (NGS) instrument platforms, assays, and bioinformatics pipelines to test precision and detect analytical deviations that may arise from reagent and instrument variation.

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, 18 insertions, 29 deletions, and three complex mutations. “With launch of the Acrometrix Oncology Hotspot Control, labs have a routine quality control material that can be used for multiple assays,” says Linh Hoang, MD, PhD, director of quality controls for Thermo Fisher Scientific. “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.”

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.

AcroMetrix quality control materials are manufactured in cGMP facilities in accordance with ISO 13485 and follow ISO 17511:2003 for metrological traceability, which ensures lot-to-lot consistency of the control material. The AcroMetrix Oncology Hotspot Control has a validated 12-month shelf life at -20°C and is stable over five freeze-thaw events. Read more about the AcroMetrix Oncology Hotspot Control.