Astrotech Subsidiary and Cleveland Clinic Sign Agreement for Breath Analysis Study to Develop a Rapid COVID-19 Breath Test
Astrotech Corporation's subsidiary, BreathTech, has signed an Investigator-Initiated Study Agreement with Cleveland Clinic to use its BreathTest-1000™ for analyzing COVID-19 diagnosis via exhaled breath. The pilot study will compare breath samples between positive and negative COVID-19 PCR test subjects to evaluate volatile organic compounds (VOCs). Successful results may lead to FDA emergency use authorization for commercial use. The study is significant as it aims for early illness detection, with Cleveland Clinic's past research supporting VOC metabolite technology.
- BreathTest-1000™ technology aims for early COVID-19 detection, potentially enhancing public health response.
- Collaboration with Cleveland Clinic could lead to significant advancements in breath analysis technology.
- Success of the study is uncertain and depends on favorable outcomes in subsequent larger studies.
- Financial benefits for Cleveland Clinic's Dr. Dweik may raise concerns about objectivity in research outcomes.
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.”
About Astrotech Corporation
Astrotech (NASDAQ: ASTC) is a science and technology development and commercialization company that launches, manages, and builds scalable companies based on innovative technology in order to maximize shareholder value. BreathTech is developing a breath analysis tool to provide early detection of lung diseases. Astrotech is headquartered in Austin, Texas. For information, please visit www.astrotechcorp.com.
This press release contains forward-looking statements that are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks, trends, and uncertainties that could cause actual results to be materially different from the forward-looking statement. These factors include, but are not limited to, the severity and duration of the COVID-19 pandemic and its impact on the U.S. and worldwide economy, the timing, scope and effect of further U.S. and international governmental, regulatory, fiscal, monetary and public health responses to the COVID-19 pandemic, the Company’s use of proceeds from its recent financings, whether we can successfully complete the development of our new products and proprietary technologies, whether we can obtain the FDA and other regulatory approvals required to market our products under development in the United States or abroad, and whether the market will accept our products and services, as well as other risk factors and business considerations described in the Company’s Securities and Exchange Commission filings including our annual report on Form 10-K. Any forward-looking statements in this document should be evaluated in light of these important risk factors. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date. The Company assumes no obligation to update these forward-looking statements.
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FAQ
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