FDA Clears AI-Based Risk Stratification Tool for Breast Cancer
The FDA has cleared ArteraAI Breast, an AI-based digital pathology tool that provides same-day risk stratification for early-stage, HR-positive, HER2-negative invasive breast cancer.
Category: Cancer
Cancer
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Cancer
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FDA Grants Breakthrough Designation to Breast Cancer Risk Assessment Test
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.
Cancer
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Boston Cell Standards Moves to Final Phase of FDA Program for Cancer Diagnostic Standards
Boston Cell Standards’ immunohistochemistry reference materials have entered the FDA’s Medical Device Development Tools qualification phase, advancing efforts to standardize IHC assay performance in cancer diagnostics.
City of Hope to Evaluate Quest Diagnostics Blood Test for Cancer Monitoring
City of Hope will evaluate Quest Diagnostics’ Haystack MRD liquid biopsy in a multi-year trial, assessing its use for monitoring breast, colorectal, ovarian, and prostate cancers in about 500 patients across 14 US sites.
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AidaBREAST Multi-Omic Assay Demonstrates Spatial Proteomics for Clinical Oncology
The assay predicts both locoregional recurrence risk and radiation therapy benefit in early-stage invasive breast cancer.
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Ultima Genomics Presents New Data for Cancer Detection Technology at AACR 2026
Ultima Genomics presented data at AACR 2026 showing its ppmSeq technology detected circulating tumor DNA at low single-digit parts-per-million in a TRACERx pilot of 50 plasma samples.
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FDA Grants Breakthrough Status to Liquid Biopsy for Liver Cancer Monitoring
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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Labcorp Launches Companion Diagnostic for Ovarian Cancer Treatment
Labcorp has launched nationwide testing with Agilent’s FDA-approved PD-L1 IHC 22C3 pharmDx, enabling identification of patients with platinum-resistant ovarian cancer eligible for pembrolizumab immunotherapy.
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Blood Test Shows Promise for Detecting Glioblastoma Using microRNA Signatures
A study identified microRNA patterns in blood plasma that could support noninvasive diagnosis and monitoring of the most aggressive form of brain cancer.
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Optical Genome Mapping Catches Missed Genetic Variants in Nearly 20% of Acute Leukemia Cases
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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Caris Life Sciences AI Algorithm Flags Potential Cancer Misdiagnoses in Lung Cancer Study
AI integrated into molecular profiling workflows identified misclassified lung cancer cases, highlighting its potential role in improving diagnostic accuracy in clinical labs.
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Biocartis Earns European Certification for Colorectal Cancer Companion Diagnostic Test
The Idylla CDx MSI Test detects microsatellite instability in colorectal cancer tissue in under three hours, supporting therapy selection for eligible patients.
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CellCarta Secures Exclusive Global Rights to Deploy Aspyre Lung Assay in Lung Cancer Clinical Trials
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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Seed Funding to Advance Biopsy Catchment Technology and Liquid Specimen Biorepository
A $4 million financing round will support development of a liquid specimen biorepository and expand biopsy catchment pilot programs at medical institutions across the US.
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ViewsML to Present Virtual Staining Research at AACR 2026
ViewsML will present research on its AI-powered virtual immunohistochemistry platform at AACR 2026, highlighting biomarker detection from routine H&E slides without traditional staining.
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GeneCentric Data Suggest Fragmentomics Could Expand Liquid Biopsy Beyond Mutation Testing
Presentations at AACR 2026 will showcase fragmentomics-based technology for detecting therapeutic markers and providing prognostic insight.
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NeoGenomics to Spotlight AI-Driven Genomic–Clinical Data Integration at AACR 2026
Presentations at the upcoming annual meeting will focus on AI-based analysis, biomarker prevalence, and therapy development.
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Labcorp and Children’s Hospital of Philadelphia Partner to Expand Pediatric Diagnostic Access
The collaboration aims to create an innovation pipeline for specialized pediatric tests across oncology, metabolic disease, and autoimmune conditions.
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