# Developing novel immunoassays specific for thyroid stimulating and TSHblocking autoantibodies

> **NIH NIH R44** · MEDIOMICS, LLC · 2021 · $495,097

## Abstract

Abstract
 Graves’ disease (GD) is the most common cause of hyperthyroidism, accounting for 60 to 80 percent of more
than 250 million cases of hyperthyroidism globally. Quantification of TSHR stimulating autoantibodies (TSAbs)
can provide important guidance for the diagnosis and management of the disease, including predicting relapse
or remission after initial anti-thyroid drug treatment or disease progression. However, TSHR blocking
autoantibodies (TBAbs) can be also found in GD patients, complicating disease diagnosis and producing a
spectrum of clinical presentations. For accurate diagnosis, assays to measure TSHR autoantibodies should be
able to discriminate between TSAbs and TBAbs. Currently, TSAbs and TBAbs are measured either by cell-based
bioassays or by binding assays. The cell-based bioassays can detect the total sum of functional TSAbs and
TBAbs, but are time-consuming, laborious, and relatively expensive. Commercial binding assays are much
simpler and faster. However, recent studies have clearly demonstrated that no commercially available binding
assay can differentiate between TSAbs and TBAbs. Given the highly problematic lack of specificity of current
binding assays, as well as the cost and time related drawbacks of the cell-based bioassays, there is a
demonstrable need and commercial opportunity for simple, cost effective, and sensitive assays that can
differentiate between TSAbs and TBAbs in patient blood samples. Developing and commercializing such assays
are the goals of this project. In Phase I, we successfully used our novel epitope screening approach to identify
unique peptide ligands that could differentiate between TSAbs and TBAbs. The goal of Phase II is to use these
unique peptide ligands to develop, optimize and validate the novel diagnostic assays for GD, followed by testing
their clinical utility. To accomplish this, we will use autoantibodies isolated from GD patient samples to identify
additional peptide ligands (Aim 1) to assure high specificity and sensitivity of the assays. In Aim 2, we will use
the best peptide ligands identified in Aim 1, together with those identified in Phase I, to develop specific assays
with improved analytical performance. For a final validation of performance and clinical utility of the newly
developed assays, we will compare the outcomes with two FDA-cleared assays on ~ 1,100 de-identified patient
samples (Aim 3). Success of the Phase II project will allow Mediomics to establish our unique assays as simpler
and more cost-effective alternatives to the cell-based bioassays, with a demonstrated ability to discriminate
between TSAbs and TBAbs in patient samples. It will also allow Mediomics to develop rapid and cost-effective
immunoassays for monitoring a range of other diseases, including infectious diseases. In Phase III, we will seek
additional funding and collaborate with our corporate partners to enter clinical trials for FDA 510(k) clearance
and to commercialize the assays as in vitro di...

## Key facts

- **NIH application ID:** 10263298
- **Project number:** 5R44DK115298-03
- **Recipient organization:** MEDIOMICS, LLC
- **Principal Investigator:** Ling Tian
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $495,097
- **Award type:** 5
- **Project period:** 2017-09-15 → 2024-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10263298

## Citation

> US National Institutes of Health, RePORTER application 10263298, Developing novel immunoassays specific for thyroid stimulating and TSHblocking autoantibodies (5R44DK115298-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10263298. Licensed CC0.

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