SensID Control Materials for Qiagen Therascreen PIK3CA RGQ PCR Kits
SensID, a Germany-based provider of controls and reference materials for clinical genomics, has introduced a set of controls for Qiagen's US Food and Drug Administration-approved and CE-IVD marked Therascreen PIK3CA RGQ PCR kits. Qiagen's kit was launched in Europe in February 2020 to aid in the identification of activating PIK3CA mutations in FFPE or blood plasma samples from patients with advanced breast cancer. The kit received FDA approval in 2019 and has been commercialized in the US as a companion diagnostic test for alpelisib (Novartis' Piqray).
SensID and Qiagen collaborated to develop the new control materials, which include 11 clinically actionable PIK3CA mutations estimated to be present in approximately 40 percent of HR+/HER2- advanced breast cancer cases and to confer a greater likelihood of responding positively to PI3K inhibitors. The control set contains seven vials (DNA in buffer) in a format matched to the reaction mixes of the Therascreen kit, and each set provides sufficient materials for about 40 runs, the company said. SensID also offers certified DNA-free human plasma that can be used in conjunction with the sample set, if suitable plasma is not available locally.
Thermo Fisher Scientific AcroMetrix Coronavirus 2019 (COVID-19) RNA Control
Thermo Fisher Scientific has launched the Thermo Scientific AcroMetrix Coronavirus 2019 (COVID-19) RNA Control to help validate and monitor COVID-19 molecular diagnostic tests. The non-infectious positive control consists of synthetic RNA transcripts containing the N, S, E, and Orf1ab regions of the SARS-CoV-2 genome. The RNA is ready for reverse transcription, PCR amplification, and detection. The kit contains two vials of RNA at concentrations that will result in low-positive and ultra-low-positive results in most commonly used PCR-based testing methods. The control is available globally as a research-use-only product and is not intended for clinical use.
Enpicom ImmunoGenomiX Software V2.0
Dutch bioinformatics firm Enpicom has released version 2.0 of its ImmunoGenomiX (IGX) Platform for the management, analysis, and visualization of T- and B-cell receptor sequencing data. The new version supports single-cell sequencing data in addition to bulk sequencing data. The ability to analyze data from both single-cell and bulk sequencing workflows in tandem provides new opportunities for immunomics research and drug development, the company said. Other new enhancements include the IGX-Compare app, which allows users to compare any two data sets to visualize and prioritize matching clones; and more extensive data support, supporting the upload of readily annotated clone tables from, for instance, 10x Genomics or Adaptive Biotechnologies. The new version also features more clonotype grouping definitions and V/J gene usage plotting.
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