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.
Astrin Biosciences has earned CAP accreditation for its St. Paul, Minn, lab, supporting the clinical rollout of Certitude Breast, a proteomics-based blood test for early breast cancer detection.
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.
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 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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Presentations at AACR 2026 will showcase fragmentomics-based technology for detecting therapeutic markers and providing prognostic insight.
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Presentations at the upcoming annual meeting will focus on AI-based analysis, biomarker prevalence, and therapy development.
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The collaboration aims to create an innovation pipeline for specialized pediatric tests across oncology, metabolic disease, and autoimmune conditions.
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The tool uses digitized pathology slides to estimate how patients will respond to therapy before surgery.
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Researchers at MD Anderson have identified a blood-based biomarker using T cell receptor sequencing that may help assess cancer risk in asymptomatic Lynch syndrome carriers, according to a study in Nature Communications.
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The clearance of the Onclarity HPV Self-Collection Kit and approval of the BD Onclarity HPV Assay aim to reduce barriers for unscreened populations.
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20/20 BioLabs’ AI-powered multi-cancer early detection test, OneTest for Cancer, is now available to approximately 40,000 clinicians via the Evexia Diagnostics platform.
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Biodesix will present seven abstracts—including two oral sessions—at AACR 2026, highlighting advances in automated myeloid testing, liquid biopsy, and NGS-based cancer monitoring platforms.
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Data from nearly 1,900 SEER-linked patients show the test identifies meaningful survival differences within the same AJCC stage.
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The updated urine test utilizes machine learning and patient ethnicity to provide individualized risk scores for aggressive disease.
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A new survey-based study finds that more than half of physically Disabled women would prefer at-home human papillomavirus testing over traditional clinic-based cervical screening.
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A new study validates a machine-learning platform that detects prostate cancer through biochemical patterns in urine samples.
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Caris Life Sciences has launched Caris ChromoSeq, a whole genome and transcriptome sequencing assay for myeloid malignancies, designed to consolidate multiple tests into a single workflow with a seven-day turnaround.
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