Guardant360 CDx can now identify patients eligible for zongertinib, the first targeted therapy approved as an initial treatment option for HER2-mutant advanced non-small cell lung cancer.
The digital pathology platform provides patient-specific risk estimates to help clinicians tailor treatment for metastatic hormone-sensitive disease.
The authorization from the New York State Department of Health makes the screening test available in all 50 states.
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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The tissue-based test identifies patients with MET exon 14 skipping alterations eligible for treatment with tepotinib.
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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.
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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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Cleveland Diagnostics has received ISO 13485:2016 certification for its IsoPSA Assay, supporting scaled U.S. commercialization following recent FDA approval for prostate cancer risk assessment.
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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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The FDA has granted Breakthrough Device Designation to Valar Labs’ Vesta Bladder Risk Stratify Dx, the first AI-powered digital pathology prognostic test for bladder cancer.
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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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Moffitt Cancer Center is partnering with Dicom Systems to scale digital pathology data management using the Unifier Platform, enabling standardized imaging workflows and supporting high-volume slide routing of up to 85,735 slides per day.
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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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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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Caris Life Sciences has applied to the New York State Department of Health for authorization of Caris Assure, a blood-based molecular profiling test for cancer using whole exome and transcriptome sequencing of 22,000 genes.
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Amplified Sciences has launched the PanAMP multicenter study to assess how its PanCystPro assay impacts clinical management decisions for patients with radiographically confirmed pancreatic cystic lesions.
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