Whole Virus Detection As Direct Marker For Infectivity Potential
Cleveland Diagnostics, Inc., Cleveland, Ohio, United States
Diagnostic technologies for identification of SARS-CoV-2 from human nasal, buccal, or saliva samples
Tech Brief: Infectivity potential is a key pandemic parameter that is completely unattained today with all screening and diagnostics modalities. We developed and validated a prototype simple, low-cost non-molecular assay that could be combined with either PCR or other readout assays to directly report the presence of whole virus in a sample.
Commercial Startup (C+)
FIGURES OF MERIT Value Proposition: All detection technologies today for COVID and other infectious diseases are molecular-based – either antigen or PCR based. While they vary in performance parameters (SN/SP, TAT, etc.), none can answer the most basic question: Does this sample capable of transmitting the disease? Our technology is based on simple, low-cost, SARS-COV-2 validated assay that serves either as a point-of-care detection test, or as an add-on pre-processing step prior to RT-PCR to convert the latter from reporting RNA to reporting whole virus. The core technology is used today in cancer diagnostics to detect changes to 3D structure of proteins, was awarded Breakthrough Device Designation by FDA in 2019, is clinically and commercially validated, and is market-ready. Key feasibility study for COVID was already completed with SARS-CoV-2, a clinical study at Cleveland Clinic underway, and the company has deep diagnostics experience, including R&D, assay development, commercial and regulatory expertise.