OncoCyte is a diagnostics company focused on developing and commercializing liquid biopsy tests for early detection of cancers. The Company’s current development strategy is to evaluate and validate specific diagnostics by detecting proteins using messenger RNA (“mRNA”) or micro RNA (“miRNA”) approach. The Company is focusing its efforts on biomarkers associated with lung, breast and bladder cancers, and especially on detectable amounts of several cancer-associated biomarkers in patients with early-stage disease.
The Company’s lead product is a confirmatory lung cancer diagnostic test which will move into R&D validation in 2016 with CLIA validation anticipated by early 2017. The Company is collaborating with The Wistar Institute of Anatomy and Biology (“Wistar”) on a large, multi-site clinical study. This collaboration involves the development of a prototype assay and a clinical study with over 2,000 blood samples obtained at six clinical sites from patients with a high-risk profile for development of lung cancer.