The goal of the pilot study will be to analyze different volatile organic compounds (VOCs) from the breath to evaluate the correlation with different disease states
Astrotech Corporation’s (NASDAQ: ASTC) subsidiary, BreathTech Corporation announced today that it has signed an Investigator-Initiated Study Agreement with the Cleveland Clinic Foundation (Cleveland Clinic). Under this agreement, BreathTech’s BreathTest-1000™ will be used to compare exhaled breath from individuals who have tested positive on a COVID-19 polymerase chain reaction (PCR) test with that from subjects who have had a negative COVID-19 PCR test.
The goal of the pilot study will be to analyze different volatile organic compounds (VOCs) from the breath to evaluate the correlation with different disease states.
“This protocol aims to build and expand on our ongoing expertise in the area of breath testing, applying the technology to COVID-19,” said Raed Dweik, MD, Chairman of Cleveland Clinic’s Respiratory Institute. “The ability to detect viral diseases, such as COVID-19, in breath may allow for early detection of illness prior to symptom onset. The purpose of this study is to determine if COVID-19 can be diagnosed by analysis of volatile compounds in a patient’s breath.”
Cleveland Clinic and BreathTech Corporation entered into a joint development and option agreement for the BreathTech technology. Dr. Dweik is an inventor of this technology. Dr. Dweik and Cleveland Clinic may benefit financially if this research is successful.
Dr. Dweik and his research team were some of the first to identify that unique VOC metabolites in the breath can be used to detect certain diseases. Cleveland Clinic researchers have successfully identified and published studies regarding the unique VOC metabolites associated with heart failure, pulmonary arterial hypertension, and liver disease.
The data that will be collected as part of this pilot study will be used by BreathTech to develop and refine its detection algorithms. Favorable results may require confirmation in a subsequent larger study. With the core mass spectrometry technology of the BreathTest-1000 being largely complete, once the sample introduction hardware and detection algorithms are developed, test, and validated, the BreathTest-1000 and data package will be submitted to the US Food & Drug Administration with a request for an emergency use authorization (EUA). If the EUA is granted, following receipt of the EUA, the BreathTest-1000 can begin the process to be offered commercially.
On March 31, 2021, Astrotech announced that it has engaged Sanmina as its contract manufacturing partner to help scale production of its various products, including the BreathTest-1000, once it becomes available to be offered commercially.
“We are very pleased to kick-off this study under the management of one of the most experienced respiratory disease detection institutions in the world,” stated Thomas B. Pickens III, CEO and CTO of BreathTech. “Despite the introduction of COVID-19 vaccines, due to the many mutations to the COVID-19 virus and other issues, we believe that our society will need to continue to be at a heightened level of caution for the foreseeable future. We are hopeful that the BreathTest-1000 proves to be useful as a screening tool to help reduce the spread of COVID-19 in hospitals, nursing homes, the work place, schools, airports, sporting and performing arts events, conferences, commercial venues, and other large gatherings.”
Source: Company Press Release