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NIH grant 1R43HL186878-01: Development of a blood-based diagnostic test for ATTR amyloidosis
Institute: {'code': 'HL', 'abbreviation': 'NHLBI', 'name': 'National Heart Lung and Blood Institute', 'admin_org_id': '12500068', 'admin_funding_url': ''}. PI: Rose Pedretti. Award: $329469.
Start: 2026-09-05T00:00:00.
PROJECT SUMMARY
Cardiac transthyretin amyloidosis (ATTR) is a progressive and underdiagnosed form of heart failure caused by
the aggregation of misfolded transthyretin (TTR) protein into amyloid fibrils. This disease is estimated to
contribute to over 500,000 heart failure-related deaths annually. Despite the availability of five FDA-approved
therapeutics, most effective when administered early, diagnosis is often delayed by 3–7 years due to reliance on
specialized technicians and subjective interpretation of biopsy or imaging results, introducing variability and
increasing operational burden. There are currently no blood-based tests available for early detection of ATTR,
and average diagnostic costs exceed $100,000 per patient. AmyGo Solutions has developed a blood-based
assay leveraging a proprietary biomarker, circulating misfolded TTR aggregates, that appears early in disease,
is absent in healthy individuals, and confers information on treatment response. The company’s platform uses a
structure-guided peptide, Transthyretin Aggregation Detector 1 (TAD1), which selectively binds pathogenic TTR
aggregates. This Phase I SBIR project aims to develop and validate a TAD1-based assay kit for automated,
low-cost detection of ATTR that is compatible with clinical laboratory workflows. Aim 1 will involve
designing, fabricating, and validating a simplified, kit-compatible format of the assay that replicates the
functionality of the current dot blot-based TAD1 assay in. Aim 2 will assess and optimize the stability of key assay
reagents under variable storage conditions to ensure consistent performance, reproducibility, and shelf-life
suitability for clinical deployment. In Aim 3 we will validate the kit-based assay in clinical samples to ensure the
necessary sensitivity, specificity, and accuracy. Successful completion of this Phase I SBIR will deliver a
validated diagnostic kit for ATTR compatible with clinical laboratory workflows. This work will enable
earlier diagnosis and broader detection of ATTR, increasing the efficacy of available therapeutics to
improve patient quality of life and lifespan. These outcomes will position AmyGo for a Phase II study focused
on manufacturing scale-up and regulatory readiness.document fetched 2026-09-13 02:45