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BARDA Awards Diassess up to $21.9M for Development of Clinical, Home Flu Tests

NEW YORK (GenomeWeb) – The US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) has awarded up to $21.9 million to Diassess as part of a cost-share contract to advance development of flu diagnostic technology for use in physician offices and eventually consumers' homes, the company said today.

Diassess said that the BARDA contract will accelerate its development of a professional-use, in-clinic flu test and sustain development of an in-home, consumer-focused flu test. It said that the BARDA funding will enable it to take both tests through clinical trials and apply for US Food and Drug Administration clearance.

The firm said that its flu diagnostic technologies give physicians and consumers an accurate diagnosis within 20 minutes. A nasal swab sample is inserted into a disposable DNA test, and a battery-powered device analyzes the sample. A visual readout indicates either influenza A or B, or provides a negative result. The firm said that its molecular diagnostic tests use nucleic acid amplification to detect the DNA and RNA of pathogens.

"Time and cost are two formidable barriers discouraging consumers from seeking care, which ultimately leads to a longer, more severe illness and additional time away from work," Debkishore Mitra, CTO and cofounder of Diassess, said in a statement. He said that the firm's flu diagnostic technologies address both barriers.

Diassess plans to launch its in-clinic diagnostic tool in 2020, and make the over-the-counter, in-home version available the following year. The in-home test requires developing a smartphone app that will connect consumers to treatment options.

The firm, founded in 2013, is also developing rapid DNA-based diagnostic tools for sexually transmitted infections, dengue, Zika, and respiratory illnesses other than flu.

Last Thursday, Cue Health announced that it won a BARDA contract of up to $30 million in funding and options to accelerate the development and regulatory validation of over-the-counter and professional-use influenza and multiplex respiratory pathogen diagnostic cartridges for its health monitoring system.

In a research note Saturday, William Blair analyst Brian Weinstein said that it is unclear how soon these technologies could come to market, but "we believe the idea of taking testing closer to the patient is a theme we will continue to hear more about and is constantly being highlighted by all constituents in the healthcare chain."