The FDA has approved Labcorp’s PGDx elio tissue complete CDx, a kit-based NGS companion diagnostic, to identify BRAF variants and guide targeted therapy selection for patients with advanced melanoma.
A highly sensitive blood test for KRAS mutations detected pancreatic cancer recurrence in more patients than standard methods, according to Northwestern Medicine research.
Tempus has launched the ArteraAI Prostate Test, a CLIA-certified, CAP-accredited AI tool for metastatic hormone-sensitive prostate cancer, offering personalized risk estimates and designed to support treatment decisions, according to the company.
Invivoscribe, in collaboration with Hitachi High-Tech, has launched the PrepQuant System, an automated platform that integrates nucleic acid extraction, concentration, and quantification to streamline molecular testing workflows.
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The FDA has granted Breakthrough Device designation to PreludeDx’s AidaBREAST assay, which uses multi-omic data and AI to assess recurrence risk and radiation therapy benefit in early-stage invasive breast cancer.
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Biotia’s clinical study, published in Microbiology Spectrum, validates an NGS and machine learning assay for UTIs, reporting 97.2% sensitivity and 99.6% specificity in direct detection and AMR profiling from urine samples.
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TCM Biotech has received FDA Breakthrough Device Designation for CatCHimera, a liquid biopsy platform for monitoring minimal residual disease in hepatocellular carcinoma using HBV–host genome integration biomarkers.
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Optical genome mapping detected clinically significant genetic variants missed by standard tests in nearly 20% of acute leukemia cases, according to a 200-patient study.
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The cloud-based system aims to address the bottleneck of translating raw genomic data into actionable information for clinical laboratories.
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CellCarta has secured exclusive global rights to deploy Biofidelity’s Aspyre Lung assay in lung cancer clinical trials, streamlining genomic testing for trial sponsors and reducing reliance on multiple vendors.
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The recommendations focus on using next-generation sequencing to evaluate off-target editing risks and chromosomal integrity.
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The collaboration focuses on implementing a liquid handling platform to streamline end-to-end laboratory processes and protocol development.
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Biodesix will present seven abstracts—including two oral sessions—at AACR 2026, highlighting advances in automated myeloid testing, liquid biopsy, and NGS-based cancer monitoring platforms.
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Modern diagnostic tools are enabling higher-resolution HLA typing for stem cell transplants, supporting faster and more precise donor-recipient matching.
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The multi-year collaboration combines kitted next-generation sequencing panels with a global laboratory network to improve turnaround times and support diagnostic programs.
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n6 has launched the icon16, a 16-well NGS library prep instrument for low-throughput clinical and research labs, featuring per-well real-time amplification control using the company’s AutoNorm technology.
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Powered by anchored multiplex PCR chemistry, the in vitro diagnostic offerings target fusion and variant detection for molecular pathology laboratories.
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The approval makes MyChoice CDx the sole FDA-approved test in the US to identify HRD-positive patients eligible for niraparib maintenance therapy.
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