Novel Breath-Based Diagnostics Could Indicate Early Rejection of Organs in Lung Transplant Patients

SQI Diagnostics Inc. (Ontario, Canada) and Owlstone Medical (Cambridge, UK) have signed a Memorandum of Understanding (MOU) to work together on the discovery, development and commercialization of breath-based biomarkers relating to invasive aspergillus lung infection and lung transplant rejection.

SQI develops and manufactures respiratory health and precision medicine tests while Owlstone is a global leader in Breath Biopsy for applications in early disease detection and precision medicine. Fungal lung infection is a large risk for certain vulnerable people such as transplant patients, where one-year survival rates for invasive aspergillosis following lung transplant is only 59%. This is largely because antifungal therapies are not appropriate for patients who are on immunosuppressants, and so early and reliable diagnosis of fungal infection is critical.

The current gold-standard diagnostic procedures for lung transplant rejection require the regular collection of tissue samples from the lung, which is invasive, expensive and can lead to serious complications. Hence, there is a clear need for a better solution. Owlstone’s non-invasive Breath Biopsy platform represents a better approach to current methods, which alongside SQI's deep experience in lung transplant diagnostics will be used to identify and deploy novel breath-based biomarkers that can indicate early rejection of organs in lung transplant patients.

Owlstone is conducting independent clinical trials to validate breath-based volatile organic compounds to diagnose Invasive Aspergillosis with high levels of performance. SQI and Owlstone will agree on the most appropriate regulatory strategy for the tests and, as necessary, liaise with the appropriate regulatory authorities to seek approval of the breath collector as a medical device and/or the approval of the lung transplant rejection in vitro diagnostic test (IVD). Owlstone will own and patent any inventions arising from the lung transplant rejection discoveries and offer an exclusive, worldwide license to SQI to commercialize the biomarkers for clinical use. SQI will undertake reasonable commercial efforts to develop and commercialize the lung transplant rejection test.

"With SQI's strategic interest in lung transplant biomarkers, we're excited to collaborate with Owlstone in applying the discovery, development and commercialization of biomarkers of acute cellular rejection and perhaps chronic rejection," said Andrew Morris, President and CEO of SQI Diagnostics. "This MOU can help further establish SQI's leadership in commercializing diagnostic testing for healthcare professionals and patients as we extend SQI's diagnostics across the continuum of care for organ transplant patients."

Related Links:
SQI Diagnostics Inc. 
Owlstone Medical

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