01
Vogel B, Acevedo M, Appelman Y, et al. (2021)
The Lancet women and cardiovascular disease Commission: reducing the global burden by 2030
The Lancet, 397(10292): 2385–2438
Cardiovascular
01 — The gap
The numbers that made
us start this company.
01 / 04
23
%
Of cardiovascular trial participants are women
Despite heart disease being the leading cause of death for American women.
SourceJAMA Cardiology, 2022
02 / 04
9
yrs
Average delay to an endometriosis diagnosis
One in ten women will have it. Few will be diagnosed in time.
SourceAmerican Journal of Obstetrics & Gynecology, 2023
03 / 04
70
%
Of chronic pain patients are women
Yet 80% of pain research has been conducted on male subjects.
SourceNature Reviews Neuroscience, 2021
04 / 04
1 IN 3
Women over 40 have a thyroid condition
Most will go undiagnosed because standard TSH ranges miss them.
SourceJournal of Clinical Endocrinology, 2024
02 — Reference ranges
"In range"
for whom, exactly?
A reference range is a statistical statement: 95% of a population falls between these numbers. But which population matters enormously. We rebuild ranges stratified by sex, cycle phase, and life stage — from our own proprietary dataset of 40,000+ women.
TSH
mIU/L
Standard range was set on a mixed population. Optimal thyroid function in women — particularly those trying to conceive — sits much lower.
Standard lab range
Legacy — mixed-sex population
0.4–4.5
◆ 2.5
0.44.5
EllaDx female-specific
Phase/stage-aware reference
0.5–2.5
◆ 1.5
0.44.5
Ferritin
ng/mL
The textbook lower bound of 10 ng/mL is based on 'not anemic.' Women with ferritin below 50 consistently report fatigue, hair loss, and restless legs.
Standard lab range
Legacy — mixed-sex population
10–200
◆ 50
10200
EllaDx female-specific
Phase/stage-aware reference
50–150
◆ 90
10200
Vitamin D
nmol/L
Levels associated with bone health in post-menopausal women are meaningfully higher than the legacy sufficiency floor.
Standard lab range
Legacy — mixed-sex population
30–125
◆ 60
30150
EllaDx female-specific
Phase/stage-aware reference
75–150
◆ 100
30150
Estradiol (luteal)
pg/mL
Phase-specific ranges — the only way to actually read a cycling woman's labs. Generic 'female' ranges collapse three different hormonal states into one.
Standard lab range
Legacy — mixed-sex population
30–400
◆ 100
30400
EllaDx female-specific
Phase/stage-aware reference
80–250
◆ 150
30400
03 — Validation
How a biomarker
earns its place in a panel.
Six steps, from clinical question to quarterly revalidation. Every marker in every panel has been through all of them.
01
Clinical question first
Symptom → hypothesis
Every panel starts with a specific symptom pattern women report. We don't build panels from a price list of available assays — we build them from the questions a 34-year-old with fatigue actually needs answered.
02
Literature & meta-analysis
Evidence grading A–D
Our medical team reviews the published evidence. We look for assays with peer-reviewed support for female-specific clinical utility — and flag the ones where the data is still thin.
03
Assay selection & validation
CV < 8% across labs
We choose assays available in CLIA/CAP-accredited U.S. labs. For sensitive markers (estradiol, testosterone) we cross-validate across two independent labs to confirm agreement.
04
Female reference dataset
n = 40,000+ and growing
Every biomarker gets rebuilt against our proprietary dataset of 40,000+ U.S. women — stratified by age, cycle phase, and life stage. Ranges are updated quarterly as the dataset grows.
05
Physician panel sign-off
3-physician consensus
Before a panel goes live, three board-certified physicians sign off on its design: which biomarkers are included, which cycle day is used, and which reference ranges trigger a flag on the report.
06
Continuous revalidation
Outcome audit every 6 mo
Every six months we audit flagged results against downstream outcomes. Ranges that don't predict anything get retired. Markers that over-flag get retuned.
04 — The evidence
Every claim, sourced.
Papers that shaped how we think about women's diagnostics — and the ones we keep returning to when building new panels.
Full bibliography of 240+ papers available at elladx.com/research · Last updated Q1 2026