Tag Archives: LGC Clinical Diagnostics

December 2023—LGC Clinical Diagnostics has launched Seraseq unmethylated and methylated ctDNA mutation mixes for assay development, validation, and routine performance monitoring. Key features of the products include global methylation of CpG sites to support all CpG methylation assays and enzymatically fragmented ctDNA for low background noise and physiologically relevant fragment sizes. Methylation status is quantified using digital PCR assays and validated by targeted next-generation sequencing panels. The products are manufactured in GMP-compliant, ISO 13485-certified facilities.

November 2023—LGC Clinical Diagnostics announced the acquisition of Kova International, a developer and manufacturer of in vitro urinalysis and toxicology quality control products for clinical laboratories.

Nov. 16, 2023—LGC Clinical Diagnostics has launched Seraseq unmethylated and methylated ctDNA mutation mixes for assay development, validation, and routine performance monitoring.

August 2023—LGC Clinical Diagnostics announced that its Trisomy 22q11 Female-Matched Reference Material is now included in its Seraseq noninvasive prenatal testing portfolio. It is a circulating cell-free DNA–like mixture of human genomic DNA (matched maternal and fetal) in a commutable matrix intended to be used as a reference material to monitor library preparation, sequencing, and detection performance. The material is processed to maintain the natural cell-free DNA size profiles of fetus and maternal DNA of approximately 170 base pairs.

July 2023—LGC Clinical Diagnostics has launched the SeraCare Accurun MS2, a full-process internal control that can be used as a tool to monitor the process integrity of sample extraction and amplification of nucleic acid amplification–based assays. The product contains positive materials of intact MS2 bacteriophage, and the ready-to-use controls can be spiked into specimens that are going through DNA/RNA extraction.

March 2023—LGC Clinical Diagnostics has launched the Seraseq gDNA BRCA1/2 LGR Somatic Mutation Mix and Seraseq gDNA BRCA1/2 LGR Inherited Mutation Mix. The products are intended for use as quality reference materials in developing, validating, and evaluating the routine performance of laboratory tests and are for research use only.  

March 2023—LGC SeraCare has developed three contrived, tumor normal cell-line–derived homologous recombinant deficiency reference materials: Seraseq FFPE HRD High-Positive RM, Seraseq FFPE HRD Low-Positive RM, and Seraseq FFPE HRD Negative RM.