US-based DirectBio pioneers an amplification-free CRISPR diagnostic technology that increases accuracy while reducing costs and turnaround time. Unlike traditional PCR tests, DirectBio’s approach works at physiological temperature, does not require specialized lab equipment, and enables multimodal testing for multiple biomarkers in a single assay. The technology, exclusively licensed from UC Berkeley and the Gladstone Institute, has been backed by over $10M in funding, including from the US government. DirectBio follows a licensing and partnering business model, targeting collaborations with major diagnostic players like Roche, Abbott, and Thermo Fisher. With a strong IP portfolio and industry interest, the company is positioned to redefine molecular diagnostics.