Fast, low-cost cartridge test to detect breast cancer from needle samples

DEVELOPMENT OF AN AUTOMATED CARTRIDGE-BASED BREAST CANCER DETECTION ASSAY- AN ACADEMIC-INDUSTRIAL PARTNERSHIP

NIH-funded research Johns Hopkins University · NIH-11097238

An affordable automated cartridge test that looks for cancer-linked DNA changes in needle-collected breast samples and returns results in under three hours for women with a palpable lump.

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionJohns Hopkins University NIH-funded
Lab location1 site (Baltimore, United States)
Project IDNIH-11097238 on NIH RePORTER

What this research studies

If you have a breast lump, this project is creating a low-cost cartridge test that uses a tiny needle sample to look for DNA changes often seen in breast cancer. The lab process converts and analyzes DNA methylation on a small panel of genes and runs the steps automatically on a cartridge machine so results come back quickly. The team is optimizing the chemistry and picking the best five-gene panel by comparing known malignant and benign samples and standard pathology. The aim is to give clinics, especially in low- and middle-income countries, a rapid way to prioritize who needs faster biopsy and pathology review.

Who could benefit from this research

Good fit: Women with a palpable breast lump who are undergoing fine-needle aspiration or biopsy, especially in clinics with limited access to pathology, are the ideal candidates.

Not a fit: Women without a palpable lump or those who need full pathology and tumor receptor profiling for treatment decisions are unlikely to benefit from this diagnostic screening assay.

Why it matters

Potential benefit: It could let women get a quick on-site test that identifies likely cancers so biopsies and treatment can happen sooner.

How similar studies have performed: Earlier prototype work and studies using methylation markers have shown promise, but a single-cartridge, rapid automated test is a novel advancement.

Where this research is happening

Baltimore, United States

Researchers

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page below.
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.