Four Diagnostic Products in the Pipeline at SQI
SQI Diagnostics (TSX-V: SQD, OTCQB: SQIDF), a leader in lung health diagnostics, has announced the development of three new diagnostic products: RALI-Dx™ IL-6 Severity Triage Test, TORdx™ LUNG, and RALI-fast™ IL-6 Severity Triage POC Test, in collaboration with University Health Network (UHN). RALI-Dx™ has received approval under Health Canada's Interim Order for COVID-19 patients. Additionally, SQI is partnering with UHN on a fungal infection study to enhance diagnostic capabilities for transplant patients. These initiatives aim to improve lung transplant success rates and patient outcomes in critical respiratory cases.
- RALI-Dx™ IL-6 Severity Triage Test approved under Health Canada's Interim Order for COVID-19 patients.
- Development of TORdx™ LUNG test aimed at aiding lung transplant decision-making, potential US FDA submission.
- RALI-fast™ test to provide rapid analysis of IL-6 in ICU patients, addressing critical care needs.
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"At UHN, we are proud to be the home for some of the most groundbreaking work in lung transplantation. We have been working with
Here is what SQI is working on:
1. RALI-Dx Triage Test Clinical Evaluation
RALI-Dx has been approved under
"As the leading research commercialization hospital in
2. TORdx™ LUNG Transplant Clinical Study
SQI is planning on entering into clinical study agreements with UHN and three US-based lung transplant centers. This work could lead to a
"Our co-development partnership is intended to significantly increase the number of lung transplants performed, and thus positively impacts the many patients currently stuck on the transplant waiting list," said Dr.
3) RALI-fast Clinical Evaluation
In
"RALI-fast is intended to help me more closely monitor the ICU patient inflammation status at the molecular level. This test has the potential to provide insights when the patient care can be de-intensified or when patient care needs to be escalated," said Dr.
4) Fungal Infection Breathe Study
SQI has also begun a preliminary clinical study of non-invasive breath diagnostic technology for the early and accurate detection of organ rejection. This would help to confirm the use model and biomarker validity in the diagnosis of aspergillosis in post-lung transplant patients.
Fungal lung infection is a large risk for people like transplant patients, whose one-year survival rates for invasive aspergillosis following lung transplant is only 59 per cent. Because antifungal therapies are not appropriate for patients who are on immunosuppressants, early and reliable diagnosis of fungal infection is critical. Right now, the best available 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. Owlstone Medical's non-invasive Breathe Biopsy platform represents a better approach which, alongside SQI's deep experience in lung transplant diagnostics, will be used to identify and deploy novel breath-based biomarkers that can detect early rejection of organs in lung transplant patients.
"With UHN's strategic interest in lung transplant biomarkers, we're excited to collaborate with UHN and Owlstone in applying the discovery, development and commercialisation of biomarkers of fungal infection," said
The RALI-Dx™ IL-6 Severity Triage Test and the RALI-fast™ IL-6 Severity Triage POC Test each help clinicians identify which patients with SARS-CoV-2 will have a severe inflammatory response and should be admitted to the hospital to help determine the risk of intubation with mechanical ventilation. Both tests measure the critical biomarker IL-6 which plays a key role in the cytokine storm phase of COVID-19.
The RALI-Dx™ IL-6 Severity Triage Test delivers results from the lab in about 60 minutes while the RALI-fast™ IL-6 Severity Triage POC test that is currently in development, delivers results at the patient point-of-care in about 15 minutes.
Only 20-25 per cent of the available donor lungs are deemed suitable by surgeons for transplant to the recipient. This donor lung scarcity means patients face long wait times, potential deterioration while on the wait list, and complications post-transplant because the patient was not as healthy because of long wait times for donor lungs.
Transplant surgeons are concerned about damage and trauma to the lung – damage that is visible, and damage, primarily inflammation, which is at the molecular level. A lack of quantitative and objective decision-making tools about lung damage – especially at the molecular level, where inflammation is a grave concern — lead many donor lungs to be rejected for transplant.
New technologies have been adopted where donor lungs are placed on a system called Ex Vivo Lung Perfusion (EVLP) before transplanting to the recipient. EVLP allows the transplant team to quantitatively assess the lung's oxygenation capability before transplant. However, even with EVLP, until now there has been no precision medicine measurements to measure inflammation of the donor lungs within viable time frames.
Chief Financial Officer
416.674.9500 ext. 277
mreddock@sqidiagnostics.com
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FAQ
What new diagnostic products is SQI Diagnostics developing as of March 2023?
What is the significance of the RALI-Dx™ IL-6 Severity Triage Test?
How could the TORdx™ LUNG test benefit lung transplant patients?
What partnership is SQI Diagnostics exploring with UHN and Owlstone Medical?