Cerenome has launched two CSF-based molecular profiling tests for CNS cancers, offering DNA and RNA sequencing panels to evaluate primary, metastatic, and hematologic malignancies in the central nervous system.
ProtaGene’s Heidelberg, Germany, lab has received CAP and CLIA accreditation, authorizing integration site analysis on human samples for lentivirus-based cell and gene therapy under U.S. federal regulations.
The transaction includes subsidiaries in the United States, Sweden, and Australia to expand transplantation diagnostic offerings.
CMS has expanded Medicare coverage for Personalis’ NeXT Personal MRD test, now allowing immunotherapy monitoring in late-stage solid tumor patients, supported by recent clinical evidence from Vall d’Hebron Institute of Oncology.
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The FDA has cleared Datar Cancer Genetics’ CellDx-Tissue, a genomic profiling assay that analyzes 517 cancer-associated genes from solid tumor tissue to support clinical decision-making, according to the company.
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Laboratories are leveraging established diagnostic and surveillance tools to track the Andes hantavirus outbreak linked to a cruise ship, with experts noting no evidence of widespread community transmission or efficient airborne spread.
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Foundation Medicine and Bristol Myers Squibb have expanded their partnership to develop an NGS-based companion diagnostic for identifying homozygous MTAP deletions, supporting targeted therapy development in precision oncology.
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The NCCN now recommends comprehensive molecular profiling for all pancreatic cancer patients eligible for therapy, regardless of stage, to better guide targeted treatment and clinical trial enrollment.
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Illumina will provide clinical sequencing services to Florida State University’s new Diagnostic Lab for Pediatric Rare Diseases, aiming to accelerate rare disease diagnostics for an estimated 30 million affected Americans.
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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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