SQI Diagnostics, a life sciences and diagnostics company that develops and commercializes proprietary technologies and products for advanced microarray diagnostics (“SQI”), along with University Health Network (“UHN”) has successfully validated the TORdx LUNG™ Organ Assessment Assay.
This test has the potential to save thousands of lives worldwide by expanding the number of lungs qualified for human transplant. The Toronto Lung Transplant Program at UHN is widely considered to be the global leader in lung transplant medicine and the leading innovator in new transplant procedures and technologies.
The validation tests were performed on SQI’s automated sqidlite™ system alongside clinical ex vivo lung perfusion (EVLP) inside the operating room at UHN’s Toronto General Hospital. These Research Use Only kits were utilized to continue TORdx assay validation and advance towards the submission of clinical study data to multiple regulatory agencies, including Health Canada and the Food and Drug Administration (FDA). These multi-agency clearances will allow TORdx test kits and sqidlite systems to be sold to transplant centers across North America.
TORdx LUNG is a proprietary assay that helps transplant surgeons determine lung quality by measuring inflammatory biomarkers of the donor organ. Utilizing these biomarker results, a score is generated based on an algorithm developed by UHN called the Toronto Lung Score. This score will help surgeons to determine if the lung is suitable for transplant, to reduce negative outcomes and time spent in the intensive care unit (ICU),and to improve overall donor organ utilization rates.
“We have already seen how the 45-minute TORdx LUNG assay will give us valuable information that, in the future, will let us make better clinical decisions regarding the transplantation of lungs that would otherwise have been rejected,” said Shaf Keshavjee, MD, Surgeon-in-Chief, Sprott Department of Surgery and Director of the Toronto Lung Transplant Program at UHN. “I am extremely proud of the work the scientific teams, including Andrew Sage, PhD, Scientific Associate at UHN and Eric Brouwer, PhD, CSO at SQI, have done to date.”
There are approximately 7,500 lungs donated in the US and Canada in 2019, but fewer than 2,000 will have been transplanted. Approximately 300 people die every year on lung recipient wait lists in North America. SQI and UHN are working together to increase the number of lungs that can be transplanted and to improve the lives of recipients and their families.
“This milestone in the process of making TORdx LUNG the standard of care for all lung transplants performed in North America and continuing our efforts towards achieving FDA approval shows the true potential for SQI’s burgeoning suite of TORdx assays,” said Andrew Morris, CEO of SQI. “Lung transplants are just the start. Discussions are currently underway for other organs, including liver and kidney. The TORdx Organ Assessment product line is going to be a significant part of SQI’s future success.”
Source: Company Press Release
