Dual-platform plasma assay for early lung cancer detection in african americans

The National Institute for Minority Health and Health Disparities awarded Biotarget DX LLC $295,924 on September 1, 2026, under the Minority Health and Health Disparities Research program (CFDA 93.307) to develop and validate a dual-platform plasma assay for early lung cancer detection in African American populations.

Biotarget DX will integrate FirePlex and CRISPR-ELISA technologies to simultaneously detect ethnicity-specific non-coding RNAs and cytokines as biomarkers for lung cancer screening. The first aim optimizes both platforms for concurrent quantification of these biomarkers. The second aim assesses diagnostic performance using an optimized panel in archived plasma samples from African American and white participants with and without lung cancer, establishing clinical validity and diagnostic accuracy. Deliverables include demonstration of high analytical sensitivity, specificity, and reproducibility, with performance data intended to support Phase II development, regulatory approval, and eventual commercialization.

The award is structured as a Small Business Innovation Research Phase I grant, which focuses on technical feasibility and commercial potential. Work is performed in Hanover, Maryland, with a period of performance from September 1, 2026, through August 31, 2027. The program aims to reduce racial disparities in lung cancer detection by providing an accessible, affordable, and rapid diagnostic approach for early screening in African American communities.

Abstract

Lung cancer is the leading cause of cancer-related mortality, with african americans (AAS) experiencing disproportionately higher incidence, more advanced-stage diagnoses, and poorer survival than white americans. A major contributor to this disparity is delayed detection due to the lack of accessible, affordable, and sensitive diagnostic tools. To address this GAP, we have developed fireplex and crisprelisa technologies that can simultaneously detect ethnicity-specific non-coding rnas (NCRNAS) and cytokines-biomarkers that demonstrate high accuracy for lung cancer detection in AAS. This sbir phase I project aims to optimize and validate this multiplex assay to enable rapid, non-invasive, and cost-effective screening in AA populations. Aim 1 will focus on integrating and optimizing the fireplex and crispr-elisa platforms for concurrent quantification of NCRNAS and cytokines. Aim 2 will assess the diagnostic performance of the assay with an optimized biomarker panel in archived plasma samples from AAS and white americans with and without lung cancer, establishing the clinical validity and diagnostic accuracy. Expected outcomes include high analytical sensitivity and specificity, reproducibility, and improved diagnostic performance through combined biomarker profiling. The proposed platform represents a novel, scalable, and accessible approach to early lung cancer detection in AAS, with strong potential to reduce racial disparities, inform timely treatment, and support future community-based validation, regulatory approval, and commercialization in phase II.