NEW YORK – Owlstone Medical said Monday that it has inked a five-year research agreement with the US Food and Drug Administration on the development of methods to identify volatile organic compounds (VOCs) in breath.
The Cambridge, UK-based firm said that the collaboration with the FDA's Center for Devices and Radiological Health Office of Science and Engineering Laboratories will support the firm's efforts to identify disease biomarkers and develop breath-based tests as well as help other researchers to identify disease-related biomarkers in breath. It said that the collaborators intend to develop through the partnership tools that can be used for the identification of VOCs in complex samples. Those tools could be used to support the development of tests to increase access to testing in rural and economically challenged areas.
Financial and other terms of the deal were not disclosed.
"As evidenced by the high level of activity and investment being driven through the FDA, the Bill and Melinda Gates Foundation, and other groups such as the US Department of Defense, the potential for breath-based diagnostics in high-need areas is becoming more widely realized," Owlstone CEO Billy Boyle said in a statement.
He added that the company will work with the FDA to create a common set of analytical methods that provide a reference for the breath research community. Owlstone noted that its research partnership with the FDA also will help it to develop and populate its Breath Biopsy VOC Atlas database of identified and quantified volatile organic compounds that are found in breath.
The company is developing a platform, dubbed Breath Biopsy, to measure in breath VOCs that result from metabolic processes that are connected with various diseases including the early detection of lung cancer and liver disease, it said. In April Owlstone received $6.5 million in funding from the Bill and Melinda Gates Foundation to aid the development of breath-based tests for tuberculosis and HIV.
The firm also said in May 2023 it had received a US Department of Defense contract to develop its handheld instrument for the detection of respiratory diseases.