Medivolve & Marvel Diagnostics Complete First Stage Clinical Testing of BlowFISH

By Charles Sternberg, Assistant Editor | 05.06.21

The technology has entered the next phase toward applying for an EUA from the FDA to test for the COVID-19 virus.

BlowFISH, a non-invasive exhaled breath diagnostic technology, has successfully cleared the first milestone in a series of clinical tests targeting application of an Emergency Use Authorization (EUA) from the United States Food and Drug Administration (FDA) to test for the COVID-19 virus.  
During the clinical trial, BlowFISH’s proprietary technology, designed to efficiently collect a substantial liquid sampling directly from deep within the lungs, successfully detected the COVID-19 virus in three test samples. Developed by Marvel Diagnostics and funded by Medivolve, the technology offers the potential for a simple, inexpensive, non-invasive, massively deployable, rapid diagnostic system for detecting respiratory illness and airborne viral threats in approximately 10 minutes.
“This is an exciting and important milestone in advancing BlowFISH toward achieving EUA status in testing for COVID-19, and providing a non-invasive, cost-effective and scalable testing alternative to nasal swab solutions currently in market," said David Preiner, CEO, Medivolve. “Making testing more accessible to populations, such as children and the elderly, where it may be difficult to administer a nasopharyngeal swab test, will become important in our transition to resuming daily life in the 'new normal'. Data obtained from BlowFISH powered testing will also further Medivolve’s mission to use innovation and artificial intelligence to close the loop in health management for every American.”
Marvel Diagnostics is partnering with a research team from Louisiana State University Health Shreveport (LSUSH) to conduct clinical trials. With the second phase of testing now in progress, BlowFISH is currently on the right track to seek EUA approval from the FDA.
“BlowFISH’s detection of the COVID-19 virus brings us one significant step closer to changing the future of diagnostics for not only COVID-19, but for a wide range of respiratory illnesses,” said Dr. Pirouz Kavehpour, UCLA professor and marvel diagnostics co-founder. “We are moving forward with urgency through proof-of-concept clinical trials, as these studies are a critical next step in making respiratory testing more comfortable, convenient and accessible for breath at a time.”
Medivolve announced a landmark investment in Marvel Diagnostic in January of 2021, providing up to $1 million in funding, subject to the achievement of certain milestones, to be used to complete the clinical studies for the BlowFISH collection system and to design and optimize, manufacture and market the device.