Breast

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.

Breast

Spotlight Medical Receives European Approval for AI Breast Cancer Test

Spotlight Medical’s myStage Dx AI breast cancer test has received CE marking under EU IVDR, enabling adoption in European oncology and pathology labs for recurrence risk assessment in ER+/HER2- early breast cancer patients.

Breast

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.

Blood Test May Help Guide Breast Cancer Treatment Decisions in Women 70 and Older

Mar 19, 2026 | Breast, Cancer, Molecular Diagnostics

Researchers found that circulating tumor DNA testing could identify which older patients with estrogen receptor–positive breast cancer are less likely to respond to hormone therapy alone.

Study Finds Multi-Omic Breast Cancer Test Predicts Radiation Therapy Benefit

Mar 12, 2026 | Breast

Data show the test can predict both locoregional recurrence risk and radiation therapy benefit in early-stage invasive breast cancer.

Researchers Identify Four New Markers for Detecting Aggressive Breast Cancer Cells in Blood

Jan 23, 2026 | Breast

Researchers at Baylor College of Medicine have identified four new protein markers that improve detection of triple-negative breast cancer cells in blood, potentially enhancing the accuracy of liquid biopsy tests, according to a recent study.

ctDNA Testing May Better Predict Breast Cancer Recurrence Than Current Standard

Jan 15, 2026 | Breast

A study reports that post-treatment circulating tumor DNA levels may better predict recurrence in HER2-positive breast cancer patients than current pCR measures.

PreciseDx Presents Validation Data for AI Breast Cancer Recurrence Test

Dec 29, 2025 | Breast

Three abstracts showcase PreciseBreast’s ability to predict recurrence risk in early-stage invasive breast cancer using digital pathology.

CTC Counts Show Value in Guiding Metastatic Breast Cancer Treatment Decisions

Dec 22, 2025 | Breast

Researchers found that circulating tumor cell counts stratified patients by disease aggressiveness and were associated with differing outcomes following endocrine versus combination therapy.

Roche Gains FDA Approval for Expanded HER2 Diagnostic Test Indications

Dec 15, 2025 | Breast

The test can now be used to identify HER2-positive metastatic breast cancer patients that could be eligible for Enhertu.

Test Validated to Predict Recurrence Risk and Radiation Therapy Benefit in Breast Cancer

Dec 12, 2025 | Breast

A blinded validation in more than 400 women shows the test provides clearer guidance on recurrence risk and radiation therapy decisions.

Medicare Covers Ultrasensitive MRD Test for Breast Cancer Surveillance

Nov 24, 2025 | Breast

Coverage applies to stage II and III breast cancer patients across three major subtypes for up to six years of recurrence monitoring.

YD Bio Expands US Access to Blood Test for Post‑Treatment Breast Cancer Monitoring

Nov 7, 2025 | Breast

The research‑use‑only test for post‑treatment breast cancer monitoring is now available through the company’s affiliate EG Biomed US.

Biodesix Expands Bio-Rad Partnership for Droplet Digital PCR Assay Development

Oct 24, 2025 | Breast

The agreement focuses on clinical validation of ESR1 mutation detection assay for advanced breast cancer testing using ddPCR technology.

Blood Test Achieves 85% Accuracy in Predicting Breast Cancer Immunotherapy Response

Aug 19, 2025 | Breast

Researchers develop PIPscore using plasma proteomics to identify triple-negative breast cancer patients most likely to benefit from immunotherapy treatment.