Rapid, low-cost breast cancer test using fine-needle samples
DEVELOPMENT OF AN AUTOMATED CARTRIDGE-BASED BREAST CANCER DETECTION ASSAY- AN ACADEMIC-INDUSTRIAL PARTNERSHIP
['FUNDING_R01'] · JOHNS HOPKINS UNIVERSITY · NIH-11399206
A quick, affordable cartridge test that checks small needle samples to help detect breast cancer in women, especially where lab pathology is limited.
Quick facts
| Phase | ['FUNDING_R01'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | JOHNS HOPKINS UNIVERSITY (nih funded) |
| Locations | 1 site (BALTIMORE, UNITED STATES) |
| Trial ID | NIH-11399206 on ClinicalTrials.gov |
What this research studies
If you have a palpable breast lump, this project aims to turn a tiny needle sample into a fast molecular result using an automated single-use cartridge. The test looks for cancer-associated DNA methylation changes in the sample and is being redesigned to run in under three hours at much lower cost. Early work will improve the DNA conversion step and pick the best five-gene marker panel, then compare performance on preserved tissue and real needle samples from people with benign and malignant lumps. The goal is a simple machine cartridge that clinics can use to prioritize patients for biopsy and faster treatment.
Who could benefit from this research
Good fit: Ideal candidates are women who have a palpable breast mass and can provide a fine-needle aspirate at a participating clinic or hospital, particularly in low- and middle-income settings.
Not a fit: People without a breast lump, those needing surgical excision for diagnosis, or patients already served by comprehensive pathology and imaging services may not personally benefit from this test.
Why it matters
Potential benefit: If successful, this could speed up diagnosis, help clinics prioritize suspicious cases, and reduce delays to biopsy and treatment in places with few pathologists.
How similar studies have performed: The team has published a prior prototype and methylation-based diagnostics and cartridge platforms have shown promise, but a fully automated, rapid cartridge for breast FNAs is still relatively new.
Where this research is happening
BALTIMORE, UNITED STATES
- JOHNS HOPKINS UNIVERSITY — BALTIMORE, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: SUKUMAR, SARASWATI — JOHNS HOPKINS UNIVERSITY
- Study coordinator: SUKUMAR, SARASWATI
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.