Clinical Evidence & Validation
Our validation program includes analytical and clinical studies aligned with CLIA Laboratory Developed Test (LDT) practices. As data lock occurs, we will publish sensitivity/specificity, PPV/NPV, calibration, and density‑stratified performance. LiquidMammo is not yet FDA‑cleared or FDA‑approved.
Why complementary screening is needed
- False‑negatives in screening mammography are real (≈1 in 8 overall).
- False‑negative rates have risen across large U.S. datasets in the last decade.
- Detection yield per 1,000 screens is modest; interval cancers are higher in dense breasts.
- False‑positives accumulate (≥1 over 10 years for ~50–60% of screened women).
The challenge in younger women
Mammography limitations are amplified in younger women due to higher breast density:
- Dense breasts are common under 50. Roughly 50–74% of women aged 40–49 have heterogeneously or extremely dense breasts (BI‑RADS C or D), compared with 20–36% of women in their 70s.
- Sensitivity drops with density. Mammography sensitivity can fall from ≈86% in fatty breasts to ≈61% in extremely dense breasts. In women under 40, first‑screening sensitivity is ≈77%.
- Cancers are masked. Among women younger than 56, many interval cancers (diagnosed within 12 months of a negative screen) are attributable to dense tissue masking.
- Lower detection yield in younger cohorts. Cancer detection per 1,000 screens is ~1.7 in women under 40 and ~2.3 at ages 40–44, versus ~5.1 overall.
- Higher false‑positive burden starting at age 40. Cumulative probability of ≥1 false‑positive over 10 years is ~50–60%.
These statistics underscore why a complementary, non‑invasive, biology‑based signal may be especially valuable for younger, dense‑breasted populations.
References (public)
- American Cancer Society – Limitations of Mammograms (false‑negatives, false‑positives)
- Susan G. Komen – Accuracy of Mammograms (sensitivity, false‑positive burden)
- Radiology Business (AJR) – U.S. false‑negative trends
- DenseBreast‑info – Cancer detection per 1,000 screens
- RSNA RadioGraphics – Dense breast challenges and supplemental screening
- BCSC – Screening performance benchmarks (PMC 5375631)
- Sprague et al. – Prevalence of dense breasts in the U.S. (PMC 4200066)
- Yankaskas et al. – Performance of first mammography in women younger than 40 (PMC 2902813)
- Boyd et al. (NEJM 2007) – Mammographic density and detection
- USPSTF (2024) – Breast cancer screening recommendations
- CDC – About Dense Breasts