New Products

Pediatric health organization Children's Mercy Kansas City has launched the Kiddose PGx test, making it the first pediatric hospital in Missouri to offer in-house pharmacogenetic testing, the organization said. Pharmacogenetic testing has been part of clinical decision making at Children's Mercy since 2014, it added, but tests previously were sent to external labs. By analyzing how a patient's genes affect responses to medications, Kiddose PGx aims to enhance medication efficacy, minimize potential side effects, and improve treatment outcomes in therapeutic areas such as cancer, organ transplantation, chronic illness, and developmental or behavioral disorders.

Quanterix has launched its Simoa p-Tau 217 Planar Kit for measuring levels of the Alzheimer's biomarker ptau-217 in plasma. The RUO kit uses antibodies licensed from Eli Lilly and runs on Quanterix's SP-X platform.

Proscia has launched its Concentriq Embeddings digital pathology software and Proscia AI Toolkit to aid the creation of artificial intelligence-based algorithms that are used to discover biomarkers and develop diagnostic tests, among other applications. Concentriq Embeddings uses four of the company's foundational models to allow users to generate numerical representations, or embeddings, from whole-slide images. The firm said that it plans to continuously add new models. The software allows users to experiment with multiple models in parallel, and the foundational models can be selected for specific needs such as image classification and segmentation, risk scoring, and multimodal data integration. The Proscia AI Toolkit is a collection of open-source tools to aid AI-based algorithm development.

CleanNA has launched the CE-IVD-compliant CleanNGS Dx, a magnetic bead-based sample prep reagent suitable for next-generation sequencing applications within diagnostic workflows. According to CleanNA, CleanNGS Dx can be used for NGS library cleanup and double-sided size selection in clinical diagnostic settings.

Biotype has launched two additions to its Modaplex PCR-based assay portfolio, the Modaplex FGFR3 Mutation Kit and the Modaplex FGFR Gene Fusion Kit, both for research use only.

The company said the assays are designed to detect actionable FGFR alterations in urothelial cancer samples in under five hours. The Modaplex platform enables advanced multiplexing and has high concordance to standard PCR and next-generation sequecning assays, according to Biotype. Tests use an integrated, one-step reverse transcriptase-PCR workflow with automated data analysis.

The FGFR3 Mutation Kit targets 13 actionable mutations in RNA extracted from FFPE tissue blocks. The Gene Fusion Kit allows for parallel detection of 12 clinically relevant gene fusions of the FGFR2 and FGFR3 genes, including seven variants of FGFR3::TACC3. Both assays can run in parallel under the same protocol. 

Genialis has launched krasID, a biomarker algorithm that can predict patient response to KRAS inhibitors across tissue histology and mutation type. It uses machine learning to model biological processes from the gene expression of patient-derived tumors and has been validated on data from non-small cell lung cancer patients as well as from preclinical and patient-derived xenograft samples for colorectal and pancreatic cancer.

LGC Clinical Diagnostics has launched ctDNA Mutation Mix v4 reference materials. The new version includes 93 variants in 71 genes, among them SNPs, indels, translocations, and CNVs, and is manufactured with a new fragmentation process that delivers lower background noise than previous versions. The reference materials are available at four variant allele frequencies: 0 percent (wildtype), 0.1 percent, 0.5 percent, and 5 percent.

MRC Holland has launched an update to its SALSA DigitalMLPA Probemix D001 Hereditary Cancer Panel 1. The original assay detected copy number variants in 28 genes and five variants associated with hereditary cancer risk. The updated version has new probes and modifications to existing probes to improve the assay's performance, including probes targeting an exon 2-6 inversion in the MSH2 gene, which is associated with Lynch syndrome. The assay has a turnaround time of 48 to 72 hours and requires at least 20 ng of DNA input per reaction.

Genomic Medicine Sweden recently published the validation results of its Genomic Medicine Sweden myeloid gene panel (GMS-MGP), developed in collaboration with SciLifeLab, in the journal Genes Chromosomes and Cancer. The 191-gene, capture-based panel includes mandatory genes in contemporary guidelines as well as emerging candidates, which provide information relevant to the diagnosis, follow-up, and treatment of myeloid malignancies.

Ambry Genetics has updated its portfolio of tests to detect genetic mutations associated with hereditary cancer. Changes include updates to the CancerNext, BRCANext, and ColoNext test panels, additional genes and indications for more comprehensive genetic assessments, and enhancements such as add-on options for genes with limited evidence.