New Products

LGC Clinical Diagnostics has launched the Seraseq Inherited Cancer DNA Mix v2, a comprehensive reference material designed to support the validation and daily quality control of cancer predisposition assays. The product is designed to address the most challenging-to-detect mutations, ensuring that labs can confidently provide accurate, actionable insights for patients at risk of hereditary cancer syndromes. According to LGC, the new reference material includes 61 clinically relevant variants across 56 cancer-associated genes, about 2.5 times more targets than the previous version. These include rare and complex mutations such as the MSH2 Boland inversion and PMS2 pseudogene homologous variants.

Datar Cancer Genetics has launched Target-MRD, an advanced molecular residual disease (MRD) monitoring blood test for solid organ cancers. The test uses both tumor-agnostic next-generation sequencing and tumor-informed, patient-customized droplet digital PCR.

Oxford Gene Technologies has launched its new next-generation sequencing-based SureSeq Myeloid MRD panel in North America. The test provides a flexible NGS workflow for the detection of ultra-low frequency biomarkers of measurable residual disease in acute myeloid leukemia.These include the largest and most complex AML-associated variants in key genes, such as large FLT3 internal tandem duplications, that often go undetected by previous generations of PCR-based enrichment technologies. OGT said its MRD panel targets 45 hotspot exons in 13 genes, with mean target coverage of up to 20,000X.

OnsiteGene of San Diego has launched XDive, a real-time PCR instrument that completes 40 thermal cycles and real-time fluorescent imaging in five minutes. The company said XDive can process up to 16 samples per run with four optical channels and support up to 64 multiplexing targets. The platform is manufactured in an ISO13485-certified facility and has received US Food and Drug Administration Emergency Use Authorization for COVID-19 and monkeypox testing from both swab and saliva samples. The platform also uses a superfast master mix provided in a dried form for storage at room temperature that has a six-month shelf life. OnsiteGene said it is seeking global distributors, licensing opportunities, and collaboration partners for XDive.

The Health Alliance has launched its Bird Flu (Avian Influenza) Assay for the detection of infections in humans with H5N1 avian influenza virus. The firm said it developed the PCR-based assay through a collaboration with Thermo Fisher Scientific and validated it in one of the Health Alliance's national labs.

Eurofins Viracor has launched a qPCR assay for Trypanosoma cruzi, the pathogen that causes Chagas disease. The test incorporates a preanalytical process designed to reduce testing delays and minimize instances of testing not performed, and the company said that it can provide results within 48 hours of sample receipt. The test supports early diagnosis and monitoring of Chagas disease, particularly in high-risk populations such as transplant recipients, where timely detection is critical to preventing disease progression or reactivation, the company said. The test has not been cleared or approved for diagnostic use by the US Food and Drug Administration.

Almaden Genomics has launched G.nome 2.0, an upgrade to its data analysis platform G.nome. A key feature of the new software is the introduction of G.nome Analytics, which connects bioinformatics workflows directly to biologist-friendly analysis tools, enabling users to further explore their data through tertiary analysis and advanced visualizations, according to the company. The platform has also undergone a comprehensive user interface upgrade, incorporating improved tools for tracking, building, and running analysis workflows to make managing large-scale bioinformatics projects more seamless, the company said.

Enhanc3D Genomics of Cambridge, UK, has launched a number of multiomics products for use in drug discovery. GenLinkConnect links GWAS SNP data to genes in specific cell types, pinpointing long-range interactions between regulatory elements and promoters. GenLinkResponse maps regulatory networks to uncover epigenetic and regulatory mechanisms that drive cell responses to treatment with compounds of interest. GenLinkProfile provides cell-specific profiling of regulatory elements and disease mechanisms, integrating 3D genomics interaction data with multiomics assays to obtain high-resolution contact maps and analyses of SNP-gene interactions. The new products are supported by Enhanc3D's visualization and data management software, GenLinkHub.

Elegen has launched Enfinia Plasmid DNA for clonal synthesis of high-complexity clonal genes up to 15 kb, verified by next-generation sequencing and shipped globally from Elegen's US facilities in 10 business days, compared to typical waits of several months for clonal synthesis of long and complex genes through existing services. Elegen also said that pricing will not exceed $.20/bp for standard-complexity sequences above 3 kb in length.

Tempus AI has launched the next-generation sequencing-based xT CDx test. The US Food and Drug Administration-approved test comprises 648 genes and is used to provide solid tumor profiling in cancer patients with solid malignant neoplasms. It detects single- and multi-nucleotide variants, insertions, and deletions and microsatellite instability status from formalin-fixed, paraffin-embedded tumor tissue specimens, and DNA isolated from matched normal blood or saliva specimens. The companion diagnostic test is intended to identify patients who may benefit from treatment with certain targeted therapies.