TORdx LUNG

2022: Announcement of a camera evaluating the suitability of donor lungs for transplantation

In mid-July 2022, the medical and technological company SQI Diagnostics announced the development of the TORdx LUNG system, which is designed to help doctors assess donor lungs for their suitability for transplantation.

Doctors typically assess donor lungs using qualitative variables such as donor health and lung size. One of the most important factors, pneumonia, is difficult to assess, so doctors often reinsure and reject the organ if there is any doubt. This means that the lungs, which may indeed be suitable for transplantation, are often rejected, further exacerbating the shortage of donor organs. As of July 2022, approximately 20% of donor lungs are accepted for transplantation, and the remaining 80% are rejected.

TORdx LUNG

TORdx LUNG technology involves measuring the level of four inflammatory biomarkers in a lung sample. The system can provide results within 40 minutes, meaning it is suitable for temporary transplant assessment requirements. If levels of inflammatory proteins in donor lungs are high, then there is a greater chance of complications, while lower-level lungs are more likely to have a better outcome. The technology has been developed and improved over time for diagnostic tests for autoimmune diseases such as celiac disease, rheumatoid arthritis, lupus nephritis, and more generally for heart health and dementia. Due to the fact that these diseases are characterized by the presence of inflammatory proteins

SQI Diagnostics' TORdx LUNG test measures four biomarkers of inflammation in a series of samples taken from the EVLP circuit. The test method is the ELISA enzyme-linked immunosorbent sandwich method with fluorescent detection. The testing format is a 96-well microtiter plate. In each well of the plate are groups of sensors for each of the four measured biomarkers. The plate and samples are loaded into an automated SQLite instrument, which then robotically processes the samples, reagents and washing solutions. The results are issued after 40 minutes, which is quite consistent with the timing of the assessment of donor lungs.

As of July 19, 2022, the TORdx LUNG test is only available as a product for investigational use. SQI Diagnostics is partnering with a number of leading American transplant centers to collect additional clinical data. For further submission of the application to the U.S. Food and Drug Administration. The developers of the technology assume that the product will be under consideration until 2023.^[1]

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