The Fleming Initiative and Cepheid have launched a 30-month study in England to compare rapid molecular and traditional culture screening for drug-resistant carbapenemase-producing Enterobacterales in hospital settings.
The updated test includes additional DPYD variants recommended by the Association for Molecular Pathology to help identify patients who may be at risk for severe chemotherapy side effects.
The test uses a new approach to identify signs of cancer recurrence with faster result times for healthcare providers and patients.
The Callisto Sample Prep System application is optimized for the PromethION platform to support whole genome sequencing workflows.
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The settlement follows a criminal conviction and addresses more than $174 million in fraudulent Medicare claims involving multiple laboratories.
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The funding will support commercial expansion of the company’s blood-based diagnostic tests and the appointment of a new president and chief operating officer.
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Research presented at ESTRO 2026 suggests circulating tumor DNA can identify which patients will benefit from combined radiation and drug therapy.
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Emerging Andes virus cases—capable of person-to-person transmission—are prompting US clinical labs to reassess hantavirus protocols and consider travel and epidemiologic exposures beyond rodent contact.
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Co-Diagnostics has completed its assay development strategy for Bundibugyo virus, following the WHO’s emergency declaration and CDC’s updated traveler screening measures amid ongoing Ebola outbreaks in the DRC and Uganda.
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The tissue-based test identifies patients with MET exon 14 skipping alterations eligible for treatment with tepotinib.
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The FDA has approved Guardant360 Liquid CDx, a blood-based test that integrates genomic and epigenomic profiling for advanced cancer, offering a broader genomic footprint and faster results.
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TGen has launched JAYseq, a clinical whole genome sequencing test for multiple myeloma that delivers results in 72 hours, enabling rapid identification of genetic changes and immunotherapy targets, according to the institute.
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Researchers at Vanderbilt-Ingram Cancer Center report that RNA sequencing of blood samples can predict immunotherapy response in high-risk breast cancer patients.
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Diasorin has received FDA 510(k) clearance for its customizable LIAISON PLEX Gastrointestinal Flex Assay, allowing labs to select from 24 targets to tailor testing based on patient needs and operational priorities.
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A multicenter clinical trial found the HelioLiver blood test detected early-stage liver cancer with 71.9% sensitivity, outperforming ultrasound’s 36.8%.
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Yourgene Health has launched the Yourgene Insight DPYD assay, expanding detection to 19 variants for DPD deficiency screening in cancer patients receiving 5-fluorouracil, with same-day results and initial Research Use Only availability.
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Researchers at Mass General Brigham have developed a digital seed amplification assay that detects TDP-43 protein seeds in cerebrospinal fluid, enabling identification of FTLD-TDP, a specific frontotemporal lobar degeneration subtype.
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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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