The firm said that during independent laboratory testing, its assay had 100 percent sensitivity for detecting HIV-1 p24, anti-HIV-1, and anti-HIV-2 in positive samples.
The firm said its rapid antigen test provided 97.3 percent sensitivity and 99.6 percent specificity in clinical studies, and it is developing a saliva-based version.
Osang previously granted nonexclusive US distribution rights to the PCR-based test to SG Blocks and has a manufacturing arrangement for the test with Nexus Dx.
The results represent a significant improvement over currently used screening tools and are spurring renewed LDT commercialization and regulatory submission efforts.
The partners believe the platform, which captures high resolution images of CTCs and clusters, has potential applications in early cancer detection and disease monitoring.