LLGC SeraCare has released AccuPlex™ SARS-CoV-2 Variant Panel 2, further expanding its line of SARS-CoV-2 molecular quality solutions to include material for Delta variant detection and analysis. AccuPlex SARS-CoV-2 Variant Panels offer full SARS-CoV-2 genome coverage with a focus on S-gene mutations in prominent variants of concern, with Variant Panel 2 featuring Kappa, Delta and Delta Plus. Wuhan wild type and an RNase P negative control are also included in the kit. This solution is compatible with multiple applications, including performance confirmation for existing SARS-CoV-2 molecular assays as well as SARS-CoV-2 variant genotyping or NGS assays.
LGC SeraCare has expanded its line of SARS-CoV-2 molecular quality solutions to include AccuPlex™ SARS-CoV-2 Variant Panel 1. The kit contains full SARS-CoV-2 genomic RNA with a focus on S-gene mutations in three prominent variants of concern (UK variant B.1.1.7, South Africa variant B.1.351, and Brazil variant P.1) with vials for each variant as well as wild type control and human RNase P negative control vials. This solution is compatible with multiple applications, including performance confirmation for existing SARS-CoV-2 molecular assays as well as SARS-CoV-2 variant genotyping or NGS assays.
LGC SeraCare has released ACCURUN® SARS-CoV-2 Antigen Reference Material Kit, a new quality measurement tool to support SARS-CoV-2 antigen testing. It is formulated for use with test methods that detect the nucleocapsid (NP) protein of SARS-CoV-2 virus – the target for the majority of the SARS-CoV-2 antigen assays currently on the market.
LGC SeraCare has expanded its innovative portfolio of SARS-CoV-2 quality solutions with the release of AccuPlex™ SARS-CoV-2 in Synthetic Oral Fluid reference material. The product is designed to support development and testing efforts around novel saliva-based SARS-CoV-2 diagnostics. It serves as an ideal research tool for assay developers as well as a complete quality solution for clinical laboratories employing such tests.
FNIH Biomarkers Consortium Launches Project that will Standardize the Measurement of Genetic Blood Tests to Track Cancer
The Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium has launched a new project under its Cancer Steering Committee that will standardize the assessment of genetic tests that use blood samples to track cancer in hospitals and laboratories across the United States. In particular, the project will develop tools to enable clinicians to measure and confidently compare circulating tumor DNA (ctDNA) test results across different laboratories.
Multi-Laboratory Assessment of a New Reference Material for Quality Assurance of Cell-Free Tumor DNA Measurements
The measurement of cell-free DNA (cfDNA) in blood plasma, a form of liquid biopsy, has great promise for early detection, treatment selection, and monitoring of cancer. Reference materials are needed to help develop, validate, and ensure the quality of new assays.
SeraCare Life Sciences, Milford, Mass, a provider of quality control materials for the infectious disease testing and next-generation sequencing (NGS) markets, has been selected as a technology partner in support of the first-ever external quality assessment program for tumor mutational burden monitoring, which is being developed by the International Quality Network for Pathology (IQN Path).
Making the Shift from Technological Innovation to Operational Excellence: Delivering on the Promise of Next-Generation Sequencing for Personalized Medicine
Targeted therapies and now recently, immunotherapies, have demonstrated great promise towards increasing response rates, as well as duration of response for cancer patients. This is often achieved by understanding biomarkers associated with therapeutic response and then stratifying patients accordingly. In many cases, this is accomplished through the application of companion diagnostics which have been developed using various approaches including immunohistochemistry, polymerase chain reaction (PCR), and more recently, next‑generation sequencing (NGS).