Diassess Inc., an Emeryville, Calif.-based next generation infectious disease testing company, was awarded a contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary of Preparedness and Response at the U.S. Department of Health and Humans Services.
The contract establishes a partnership to advance development of its flu diagnostic technology for use in physician offices and eventually in consumers’ homes.
The period of performance is for up to five-years, with Government cost-share funding up to $21.9 million if all options are exercised.
The BARDA contract accelerates Diassess’ development of the professional-use, in-clinic flu diagnostic test and sustains development of the in-home, consumer-focused flu diagnostic test, the latter of which includes the creation of a smartphone-based app that will connect consumers to treatment options. The funding allows Diassess to take both tests through clinical trials and submit to the U.S. Food and Drug Administration (FDA) for clearance.
Led by John Waldeisen, CEO, and Debkishore Mitra, CTO, Diassess is advancing flu diagnostic technologies that give physicians and consumers an accurate diagnosis within 20 minutes. Beginning with a nasal swab, the sample is inserted into a disposable DNA test. The battery-powered device quickly analyzes the sample and a visual readout indicates either influenza A, B or negative diagnosis.
The in-home version will use a smartphone app to directly connect the consumer to treatment options.
The company plans to launch its in-clinic diagnostic tool in 2020, and make the over-the-counter in-home version available the following year. Founded in 2013, Diassess also is applying its expertise to develop rapid DNA-based diagnostic tools for infectious diseases such as sexually transmitted infections (STIs), Dengue and Zika, and other respiratory illnesses.