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New Products Posted to GenomeWeb: Thermo Fisher, Exact Sciences, Biocartis, BioSkryb, More

Thermo Fisher Scientific TrueMark STI Select Panel

Thermo Fisher Scientific has launched the Applied Biosystems TrueMark STI Select Panel, a PCR-based research-use-only test designed to simultaneously detect Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium. The test also targets RNase P as a human internal control. The assay can be performed with samples collected from vaginal or genital swabs in one reaction well and is optimized for use with QuantStudio real-time PCR instruments. These samples can also be prepared using workflows that currently exist in most labs that use the Applied Biosystems MagMax Viral/Pathogen kits automated on a KingFisher Purification System instrument and mixed with the Applied Biosystems multiplex master mix onto a 96-well or 384-well plate. The TrueMark STI Select Panel is sold as a combo kit, which includes the STI panel assay, master mix, and positive controls.

Exact Sciences OncoExTra Therapy Selection Test

Exact Sciences has launched the OncoExTra therapy selection test in the US. OncoExTra uses next-generation sequencing to analyze DNA and RNA, providing doctors and patients a complete molecular picture of the patient's cancer. OncoExTra profiles the entire exome and the transcriptome across approximately 20,000 genes. Exact noted that the American Society of Clinical Oncology has updated its guidelines to recommend RNA-based fusion testing for patients with no actionable information provided by a standard DNA, multigene panel test. OncoExTra also analyzes all National Comprehensive Cancer Network-recommended genes for patients with solid tumors, and uses matched tumor-normal sequencing to limit false positives and allow physicians to make clinical decisions based on somatic variants detected. The test includes information on targetable mutations and fusions, immuno-oncology signatures, and clinical trial options. Healthcare providers can also order IHC panels and individual stains concurrently, allowing them to receive all actionable tumor information from the company.

Biocartis Idylla IDH1-2 Mutation Assay Kit (RUO)

Biocartis has launched the Idylla IDH1-2 Mutation Assay Kit for research use only. Currently only available to select customers, the assay is the first developed with the company's new Idylla Flex technology that separates the generic components of an Idylla test from the test-specific components. Idylla Flex shortens the development time of new Idylla assays by combining a generic Idylla cartridge with test-specific components that are provided in a separate vial and can be added to the cartridge along with the sample. The format will first be available for use with formalin-fixed paraffin-embedded samples, peripheral blood mononuclear cells, whole blood, or extracted DNA.

Mutations in the isocitrate dehydrogenase 1 (IDH1) and 2 (IDH2) genes are oncogenic drivers that are frequently found in a variety of human malignancies, including gliomas, acute myeloid leukemia, cholangiocarcinoma, chondrosarcoma, and thyroid carcinoma. The new Idylla assay can detect five mutations in IDH1 and 10 mutations in IDH2, along with an integrated processing control, with a turnaround time of less than two hours, the company said.

BioSkryb Genomics ResolveOme and BaseJumper

BioSkryb Genomics has launched the ResolveOme Whole-Genome and Transcriptome Amplification System and BaseJumper Bioinformatics Platform.

Single-cell methods generally can only decode a limited portion of the genome or transcriptome, or rely on bulk samples, which lowers resolution and can be time-intensive, BioSkryb noted. ResolveOme addresses these limitations through its single-cell whole-genome amplification technique that combines the company's primary template-directed amplification (PTA) method with full-transcript reverse transcription. As a result, ResolveOme enables the simultaneous exploration of the whole genome and whole mRNA transcriptome from the same single cell, the company said. Additionally, the assay can be used to examine the whole exome or smaller targeted portions of the genome based on researcher needs.

BaseJumper has been designed to complement ResolveOme by streamlining the process of single-cell informatics at scale. The platform enables the rapid organization and mapping of multiomic (DNA, RNA, and protein) data generated by the ResolveOme system so researchers can easily interpret and visualize large data sets through dynamic filtering capabilities and a suite of visualization applications, BioSkryb said.

Parse Biosciences Evercode TCR and Gene Capture

Parse Biosciences has launched the Evercode TCR and Gene Capture single-cell immune profiling and enrichment products. Evercode TCR enables researchers to profile T-cell receptors together with whole transcriptomes in up to 1 million single cells, the company said. Combining TCR sequences with gene expression at this scale makes it possible to track TCR clonotypes across different T-cell subtypes and activation states to understand the immune repertoire at exceptional resolution, Parse added.

The Gene Capture product is designed to reduce sequencing needs for larger studies. It focuses on the most relevant genes, making it possible to scale projects to millions of cells and hundreds of samples. Researchers can order a predesigned panel of approximately 1,000 genes relevant to immunology, the Immune1000, or design a panel unique to their needs, Parse said.

LevitasBio: LeviSelect Cell Depletion & Enrichment Kits

LevitasBio unveiled its LeviSelect suite of cell depletion and enrichment kits for immunology research. The kits are a targeted expansion of the company's LeviCell Advanced Workflow protocol for the targeted selection of immune cell subpopulations for downstream analysis and further subsetting. The kits, which allow for multiplexing, can be used to simultaneously enrich T cells, B cells, NK cells, and monocytes in an unbiased manner, with future kits expected to include subtypes from these populations.

LynxDx: MyProstateScore 2.0 (MPS2)

LynxDx launched MyProstateScore 2.0 (MPS2), a noninvasive, genomically driven 18-biomarker urine prostate cancer screening test meant to help guide clinical decisions for patients with elevated prostate-specific antigen (PSA) or abnormal digital rectal exam (DRE) findings through stratified risk assessments. MPS2 serves as a standalone biomarker test for biopsy-naive patients, while for patients with a prior negative biopsy, it includes relevant clinical factors specific to a patient in the algorithm.

Cambridge Molecular Diagnostics SwiftDx Mycoplasma Detection Kit

UK-based Cambridge Molecular Diagnostics has launched the SwiftDx Mycoplasma Detection Kit, a lateral flow test for the detection of Mycoplasma contamination. The test uses an adapted PCR method called eAMP, and can provide accurate results in minutes, suiting it for use in academic laboratories and for manufacturing in the biotech and pharmaceutical industries. The assay uses a small sample taken directly from cell culture media supernatant, and has a detection limit of less than 10 cfu/mL after day three of culture, the company said.

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