Award
NIH Reporter #1R44CA310364-01
Scaling Lymphoma Diagnosis: A Cost-Effective Gene Expression Assay for Broad Implementation
Recipient
RAIZ DIAGNOSTICS, INC.
Award Amount
$1,770,000.00
Ceiling
$1,770,000.00
Awarded
September 16, 2025
Identifier
1R44CA310364-01
This award funds RAIZ DIAGNOSTICS, INC. to develop and validate a cost-effective gene expression assay for lymphoma diagnosis, aiming for clinical deployment and regulatory approval over a two-year period with a budget of $1.77 million.
Description
The project focuses on developing a low-cost, same-day gene expression assay for lymphoma diagnosis. It aims to validate and deploy the assay in clinical settings, with regulatory approval and commercialization plans. The project involves generating CLPA expression data from 2,500 cases, validating the assay as a CLIA-compliant test, and initiating FDA pre-submission activities. It addresses a significant market opportunity with over 260,000 suspected lymphoma biopsies annually in the U.S. The project aims to improve lymphoma diagnosis accuracy and access, especially in resource-limited settings.