Information for Clinicians

Overview

LiquidMammo™ is a supplemental, non‑invasive microRNA‑based liquid biopsy designed to strengthen breast‑cancer screening performance — particularly in dense‑breast populations where mammographic sensitivity is reduced.

LiquidMammo is currently being developed as a CLIA Laboratory Developed Test (LDT). It is not yet FDA‑cleared or FDA‑approved.

Why consider a supplemental molecular test?

Improved assessment in dense breasts

Mammographic sensitivity may fall to ~61% in BI‑RADS D tissue. Molecular signal is density‑independent.

Non‑invasive & easy to add

A routine blood draw — no radiation, no compression, minimal patient burden.

Supports clinical decision‑making

Provides complementary biological information to guide follow‑up, escalation, or imaging selection.

Biological rationale

microRNAs regulate gene expression across oncogenic pathways, including proliferation, immune modulation, DNA repair, and metastatic signaling. Their stability in blood and early dysregulation make them suitable biomarkers for screening support.

How the test works

1 — Order through your practice

The test is clinician‑ordered, like routine lab assays. Phlebotomy in‑clinic or via partner labs.

2 — Laboratory microRNA analysis

Plasma is processed under controlled SOPs. A tumor‑associated microRNA signature is quantified and analyzed.

3 — Clinician‑ready report

You receive a structured report including classification, density‑contextual interpretation, and recommendations.

Ideal patient populations

Interpreting results

Negative / Low‑risk

Suggests no microRNA signature consistent with known cancer‑associated patterns. Continue guideline‑directed screening.

Positive / Elevated signal

Indicates microRNA changes associated with tumor biology. Consider further imaging (diagnostic mammography, ultrasound, MRI).

Results should always be interpreted alongside clinical history, density, and imaging.

Safety, quality, and compliance

CLIA environment

Testing is performed in a certified CLIA laboratory under strict SOPs, QC steps, and proficiency testing.

Sample integrity

Stabilized plasma collection ensures reproducibility. Chain‑of‑custody safeguards traceability.

Privacy & security

All patient data are de‑identified for analysis and processed under HIPAA‑aligned workflows.

Clinician enrollment

We are onboarding a limited number of clinical partners for validation and early access. Practices serving dense‑breasted and under‑screened populations are encouraged to inquire.

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