# Phase IIB: Development of TruT Algorithm for Commercialization in Androgen Disorders

> **NIH NIH R44** · FUNCTION PROMOTING THERAPIES, LLC · 2022 · $1,008,781

## Abstract

ABSTRACT
Background:
Measurement of free testosterone (T) concentrations is indicated in the diagnosis of androgen disorders,
including hypogonadism in men; hirsutism, polycystic ovary syndrome (PCOS), and androgenic alopecia in
women; pubertal disorders in boys and management of gender affirming hormone therapies for transgender and
gender diverse (TGD) persons. This Phase IIB proposal aims to continue the development of the TruTTM
algorithm by validating it in common conditions characterized by altered estradiol (E2), T, and SHBG
concentrations and incorporating interaction of E2 with T for wider commercial adoption in women in whom E2
levels vary greatly across the menstrual cycle and in TGD population.
Approach:
This application follows the FDA’s published “Guidance for Industry: Bioanalytical Method Validation”. The
essential parameters to determine the acceptability of a bioanalytical method include its technical performance
(accuracy, precision, sensitivity, selectivity, stability, and matrix effects). Reference ranges should be determined
in appropriate human samples. The analytical method should be validated for intended use (e.g., determination
in conditions of intended use, such as persons with altered E2 and T levels, women with PCOS, TGD persons
etc.). In studies through the Phase II, we demonstrated that the method has superior performance characteristics
and extended the validation of TruTTM algorithm in conditions characterized by altered SHBG concentrations. In
the proposed Phase IIB studies, we will generate the v2.0 of TruTTM algorithm by incorporating the dynamics of
the E2 induced perturbation in free T levels, validate it in men, women and TGD populations (Aim 1) and deploy
HIPAA compliant, secure integration of the algorithm into electronic medical records (EMR) workflow (Aim 2).
Future Directions and Commercialization potential:
The phase IIB program will enable the pilot commercial deployment of a HIPAA compliant (FDA registered)
platform for commercializing the TruTTM (v2.0) algorithm embedded into electronic medical record (EMR) for
wider clinical adoption. These studies will improve clinical care and advance our fundamental understanding of
dynamic regulation of T bioavailability in diverse populations including unrepresented sexual and gender
minorities.

## Key facts

- **NIH application ID:** 10603887
- **Project number:** 2R44AG045011-04
- **Recipient organization:** FUNCTION PROMOTING THERAPIES, LLC
- **Principal Investigator:** Ravi Jasuja
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,008,781
- **Award type:** 2
- **Project period:** 2014-09-15 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10603887

## Citation

> US National Institutes of Health, RePORTER application 10603887, Phase IIB: Development of TruT Algorithm for Commercialization in Androgen Disorders (2R44AG045011-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10603887. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*