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About EllaDx

We started this
because someone
had to.

2024
Founded
Dallas, TX
Headquarters
Our mission

To build the diagnostic infrastructure women deserved forty years ago.

Every part of modern medicine - from the drug trial to the reference range on your lab report - was designed around the average American man. For decades, U.S. women were excluded from clinical research on grounds of "hormonal variability." The result is a healthcare system that treats us as an outlier rather than the center of the work.

EllaDx is closing the gap for American women. Panels that start from female physiology. Peer-reviewed research on optimal levels by cycle phase and life stage, surfaced alongside every result. An evidence base written by, reviewed by, and tested on women. Not because it's a niche - because it's half the country.

Why we built this

A seven-year
diagnosis.

“

I trusted my doctors. My doctors trusted the reference range. The reference range was wrong about me.

One of the first women to test with EllaDx
I

The labs were always 'normal.'

She went to her primary care doctor with the same story every quarter for two years: crushing fatigue, a libido that had gone quiet, anxiety that arrived on schedule. Every round of labs came back within range. Every visit ended with the same sentence - 'Your numbers look fine. Have you thought about therapy?'

II

Seven visits. Seven 'you look fine.'

Seven different providers - the exact people she'd been taught to trust with her body - told her, politely, that the data didn't match the feeling. No one ran a thyroid panel with antibodies. No one asked what day of her cycle she'd drawn her labs. No one considered that the reference range might not have been built for her. She started to wonder whether she was the problem.

III

The reference range is an editorial decision.

She pulled her own reports and started reading the primary literature - how reference ranges get built, who counts as 'normal,' who gets excluded, which biomarkers women are routinely denied on the grounds of cost. The deeper she went, the angrier she got. Her story, she discovered, wasn't rare. It was the default for American women.

IV

Build what should have existed.

That's the story we kept hearing, from every woman we interviewed across the country. Fatigue, brain fog, cycles gone sideways - met with a shrug and a referral to therapy. So we built the panels we wished we'd had. Ten of them. 180+ biomarkers. Peer-reviewed research on what's optimal for women, surfaced alongside every result.

A women's health timeline

A century of progress,
still catching up.

The milestones that shaped women's diagnostics in the United States - and the ones that are still being written.

1928

The first women's cancer screen

Pap smear

Dr. George Papanicolaou presents what becomes the Pap smear at a conference in Battle Creek, Michigan. Adopted across American hospitals in the 1940s, it goes on to become the most successful cancer screening program in U.S. history.1,2

  1. 1.Papanicolaou GN. (1928). New Cancer Diagnosis. Proceedings of the Third Race Betterment Conference, 528–534.
  2. 2.Papanicolaou GN, Traut HF. (1941). The diagnostic value of vaginal smears in carcinoma of the uterus. American Journal of Obstetrics & Gynecology, 42: 193–206.
1960

The pill

FDA approval

The FDA approves Enovid for contraception. For the first time, American women have a federally regulated tool to manage their own reproductive biology - and the demand reshapes how U.S. medicine thinks about hormones.1,2

  1. 1.U.S. Food & Drug Administration. (1960). NDA 10-976 - Approval of Enovid (norethynodrel/mestranol) for contraception. May 9, 1960.
  2. 2.Junod SW, Marks L. (2002). Women's trials: the approval of the first oral contraceptive pill in the United States and Great Britain. Journal of the History of Medicine, 57(2): 117–160.
1977

Women barred from early trials

The exclusion era

After the thalidomide tragedy, the FDA issues guidance excluding 'women of childbearing potential' from Phase I and early Phase II studies. The exclusion becomes the industry default for nearly two decades, and reference ranges keep getting built on male-only data.1,2

  1. 1.U.S. Food & Drug Administration. (1977). General Considerations for the Clinical Evaluation of Drugs. FDA 77-3040. (Rescinded 1993.)
  2. 2.Merkatz RB, Temple R, Sobel S, Feiden K, Kessler DA. (1993). Women in clinical trials of new drugs - a change in FDA policy. New England Journal of Medicine, 329(4): 292–296.
1990

Office of Research on Women's Health

Federal mandate

Congress establishes the Office of Research on Women's Health at the NIH - the first federal mandate to study how disease, drugs, and biomarkers behave differently in women.1,2

  1. 1.Pinn VW. (1994). The role of the NIH Office of Research on Women's Health. Academic Medicine, 69(9): 698–702.
  2. 2.NIH Office of Research on Women's Health. About ORWH - History. https://orwh.od.nih.gov
1993

The NIH Revitalization Act

Women in trials, by law

Congress passes the NIH Revitalization Act, requiring women and minorities in federally funded clinical trials. Treatment protocols and reference ranges built on men-only data finally start getting questioned at scale.1,2

  1. 1.NIH Revitalization Act of 1993, Pub. L. No. 103-43, 107 Stat. 122 (1993). Subtitle B - Clinical Research Equity Regarding Women and Minorities.
  2. 2.Mastroianni AC, Faden R, Federman D, eds. (1994). Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies. National Academies Press.
1994

BRCA1 isolated

Genetic diagnostics

Dr. Mary-Claire King's team at UC Berkeley maps BRCA1 to chromosome 17. Hereditary breast and ovarian cancer testing becomes possible - the first widely used genetic screen designed around a disease that disproportionately affects American women.1,2

  1. 1.Miki Y, Swensen J, Shattuck-Eidens D, et al. (1994). A strong candidate for the breast and ovarian cancer susceptibility gene BRCA1. Science, 266(5182): 66–71.
  2. 2.Hall JM, Lee MK, Newman B, et al. (1990). Linkage of early-onset familial breast cancer to chromosome 17q21. Science, 250(4988): 1684–1689.
2006

The first cancer-preventing vaccine for women

HPV vaccine

The FDA approves Gardasil, the HPV vaccine. For the first time, a vaccine prevents a cancer that predominantly affects women. Cervical cancer rates in vaccinated U.S. cohorts ultimately fall by more than 80%.1,2

  1. 1.U.S. Food & Drug Administration. (2006). FDA approves new vaccine for prevention of cervical cancer. FDA News Release, June 8, 2006.
  2. 2.Lei J, Ploner A, Elfström KM, et al. (2020). HPV vaccination and the risk of invasive cervical cancer. New England Journal of Medicine, 383(14): 1340–1348.
2013

Sex differences, finally recognized in dosing

Sex-based dosing

The FDA halves the recommended dose of zolpidem (Ambien) for women after two decades of data showing sex differences in drug metabolism. Dozens of other medications come under review.1,2

  1. 1.U.S. Food & Drug Administration. (2013). FDA Drug Safety Communication: Risk of next-morning impairment after use of insomnia drugs; FDA requires lower recommended doses for certain drugs containing zolpidem. January 10, 2013.
  2. 2.Farkas RH, Unger EF, Temple R. (2013). Zolpidem and driving impairment - identifying persons at risk. New England Journal of Medicine, 369(8): 689–691.
2016

'Sex as a biological variable'

NIH SABV policy

NIH mandates that sex be considered a biological variable in every preclinical and clinical study it funds. The research base underpinning women's reference ranges begins, slowly, to catch up.1,2

  1. 1.Clayton JA, Collins FS. (2014). Policy: NIH to balance sex in cell and animal studies. Nature, 509(7500): 282–283.
  2. 2.NIH Notice NOT-OD-15-102. (2015). Consideration of Sex as a Biological Variable in NIH-funded Research. Effective January 25, 2016.
2024

Women-first diagnostics go direct

EllaDx launches

A generation of American women refuses to accept 'your labs look normal' as an answer. EllaDx launches in Dallas with 10 panels and 180+ biomarkers, each curated against the peer-reviewed literature on what's optimal for women.1,2

  1. 1.EllaDx, Inc. (2024). Launch announcement - Dallas, TX, October 2024.
  2. 2.White House Initiative on Women's Health Research. (2024). Fact Sheet: President Biden to Sign Executive Order to Advance Women's Health Research. March 18, 2024.
What's next

A lot, honestly.
Start here.

Test with us, read what we've written, or come work here. All three have the same outcome - a body of evidence built with you in mind.