Common questions, and a quick quiz

MammoAlert is a blood-based breast cancer risk assessment test. A trained healthcare worker takes a finger-prick sample, which is run on the portable Nidan BioLab™ analyzer against a five-protein biomarker panel. An AI model interprets the pattern across all five biomarkers and returns a risk result in under 30 minutes — no imaging center or radiologist required.

No. MammoAlert is designed to expand who gets screened at all, not to replace mammography where it’s already available. A positive or elevated risk result is intended to route a patient toward diagnostic follow-up, including imaging, not to stand in as a final diagnosis.

The underlying AI model was developed and threshold-tuned computationally, then checked against 350+ actual patient samples, and further validated across 9 independent retrospective studies (1,055 plasma samples total) using Harae Dx’s original four-biomarker panel, with sensitivity and specificity averaging approximately 90% across those studies. A fifth biomarker was subsequently added to build the current five-biomarker model; retrospective clinical validation of that five-biomarker version is ongoing. Full study-by-study results are on our Science & Validation page.

Not yet. MammoAlert is for investigational use as clinical validation continues, and Harae Dx is pursuing the FDA Breakthrough Device pathway, which would support an expedited path toward regulatory review if granted.

Initial focus regions are the U.S., India, and APAC. India and China in particular have enormous unmet screening need — China has no formal national screening program, and fewer than 3% of eligible women in India are regularly screened — which is where a portable, low-cost test can have the most impact.

Reach out via our Contact page or email info@haraedx.com. We welcome conversations with hospitals, physicians, governments, NGOs, and investors.