FDA Grants Breakthrough Device Designation to Cleo Skin AI Pathology Tool
Clinical studies found improved melanoma detection sensitivity, while a small US evaluation showed a 20% reduction in slide analysis time.
Category: Cancer
Cancer
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Cancer
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Pennsylvania Law Mandates No-Cost Coverage for Colorectal Cancer Blood Tests
A new Pennsylvania law will require state-regulated insurers and Medicaid to cover blood-based colorectal cancer screening tests with no cost-sharing, Dec 21, 2026.
Cancer
Latest
Hologic to Acquire Reveal Genomics to Expand Breast Cancer Genomic Testing Portfolio
Hologic has agreed to acquire Reveal Genomics, adding the HER2DX assay to its oncology diagnostics portfolio and expanding genomic testing options for breast cancer, according to a company statement.
Guardant Health to Highlight Advances in Liquid Biopsy for Cancer Monitoring at ESMO 2026
Guardant Health will present 25 abstracts at ESMO 2026, highlighting new data on ctDNA liquid biopsy for cancer monitoring, including MRD surveillance and therapy resistance in lung, colorectal, and gastric cancers.New research examines how circulating tumor DNA testing could help detect cancer recurrence, track treatment response, and identify resistance across multiple cancer types.
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AI Analysis of Pathology Slides Shows Promise for Guiding Lung Cancer Biomarker Testing
A study of more than 60,000 lung cancer cases found that AI could predict the presence of 12 biomarkers with more than 80% sensitivity, potentially helping laboratories prioritize additional testing.
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Biodesix Partners With Vanderbilt to Develop Lung Cancer Risk Test Combining Blood Tests and Imaging
Biodesix and Vanderbilt have partnered to develop an AI-powered lung cancer risk test that combines blood-based and imaging biomarkers, with initial data to be presented at RSNA 2026 and commercial launch targeted for 2028.
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Collaboration Seeks to Develop Prostate Cancer Companion Diagnostic for Local Lab Testing
SOPHiA GENETICS and Myriad Genetics are collaborating to develop a decentralized prostate cancer companion diagnostic, aiming to enable local labs to assess DNA repair deficiencies using the PrGIS biomarker in clinical trials.
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Clinical Trial Evaluates Blood Test for Early Breast Cancer Detection Alongside Mammography
Keck Medicine of USC has launched a phase 1 trial to assess whether a liquid biopsy detecting rare cells and extracellular vesicles can help identify early-stage breast cancer alongside standard mammography.
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New AI Tools Aim to Identify Tissue Samples at Risk of Failed Molecular Testing
Aignostics has launched HETA Clinical, an AI-based suite for digital pathology that analyzes whole-slide H&E images to assess tumor content and tissue quality, aiming to reduce molecular test failure rates in clinical labs.
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Blood-Based Colorectal Cancer Screening Averts More Deaths Than Stool Tests, Modeling Shows
A modeling study presented at ACG 2026 projects that blood-based colorectal cancer screening averts more deaths and increases colonoscopy completion rates compared to stool-based methods, according to data from Guardant Health.
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Study Validates Cervical Sample Test for Endometrial Cancer Detection
The DNA-based test showed 96.8% specificity in cervical samples and could help physicians determine which patients need further testing for endometrial cancer.
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Real-World Evidence from Over 2,000 Patients Supports Routine Blood-Based Lung Nodule Testing
Biodesix presented data at CHEST 2026 from over 2,000 patients in the CLARIFY study, highlighting how Nodify Lung blood-based testing integrates with PET imaging to improve follow-up adherence for pulmonary nodules.
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Why Better Cancer Detection May Depend on Measuring Biomarkers Differently—Not Finding New Ones
Analyzing the structure of existing biomarkers could reveal new information about cancer, helping laboratories deliver more accurate and clinically useful results.
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TissueCypher Identifies Risk of Barrett’s Esophagus Progression Beyond Biopsy Alone
Castle Biosciences’ new data presented at ACG 2026 show the TissueCypher test offers objective risk stratification for Barrett’s esophagus progression, providing information beyond standard histopathology.
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University Spin-Out Launches to Commercialize Adrenal Cancer and Hormone Disorder Tests
IMS Solutions, a University of Birmingham and Imperial College London spin-out, has raised £1.1 million to commercialize mass spectrometry-based steroid biomarker tests for adrenal cancer and PMOS, with clinical validation underway.
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Multi-Omics Blood Test Shows Promise for Early Detection of Three Gynecologic Cancers
New data show high diagnostic performance for ovarian, endometrial, and cervical cancers, with a targeted assay designed to run on existing clinical laboratory equipment.
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Multi-Omic Test Predicts Radiation Therapy Benefit in Early-Stage Breast Cancer, Study Finds
An independent validation study of 426 patients evaluated the assay’s ability to assess 10-year recurrence risk and identify patients more likely to benefit from radiation therapy.
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10x Genomics, Fred Hutch Launch Cancer Diagnostics Research Collaboration
10x Genomics and Fred Hutchinson Cancer Center have launched a multi-project collaboration to study single cell and spatial profiling for cancer diagnostics, including biomarkers in bladder cancer and residual disease detection in AML.
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