NIH-funded research Sbir 1 grant

TruE2 diagnostic tool to measure free estradiol levels

Official title: Development and Performance Evaluation of a TruE2 Diagnostic Algorithm for Free Estradiol

Funded at Xyone Therapeutics INC. · NIH-11316439 · Data updated 2026-11-12

A health-focused project to create and test a new algorithm that better measures the biologically active free estradiol in blood.

Quick facts

Grant typeSbir 1 grant
Study typeNIH-funded research
Funding institutionXyone Therapeutics INC.
NIH-funded
Lab location1 site (Weston, United States)
Project startSeptember 21, 2026
Project endSeptember 20, 2027
Funding year2026
Award (this year)$396,322
NIH project number1R43AG099628-01
Project IDNIH-11316439 on NIH RePORTER

Who could benefit from this research

Could help

Patients with hormonal disorders where fE2 measurement is clinically important, including gynecomastia, puberty disorders, breast cancer hormone therapy, and IVF contexts.

Less likely to help

Patients whose conditions do not involve estradiol binding or who do not require precise fE2 measurement may not benefit.

What this research studies

This project aims to develop a TruE2 diagnostic algorithm that estimates the free fraction of estradiol (fE2) in people, addressing limitations of current methods. It uses biophysical insights and laboratory data to account for how estradiol binds to SHBG and albumin, and how testosterone can influence binding. The work focuses on improving accuracy and practicality for diagnosing and monitoring hormonal disorders in patients such as gynecomastia, pubertal issues, breast cancer therapy, and IVF contexts. The study will involve algorithm development and performance evaluation in a clinical-relevant setting.

Why it matters

Potential benefit: If successful, clinicians could obtain more accurate fE2 measurements to guide diagnosis and treatment of hormonal conditions.

How similar studies have gone: Previous methods have shown limitations; this project seeks to overcome them with a more accurate, allosteric-aware approach.

Where this research is happening

  • Xyone Therapeutics INC.
    Weston, United States
    Active

Researchers

  • Principal investigator: Jasuja, Ravi — Xyone Therapeutics INC.
  • Study coordinator: Jasuja, Ravi

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.