SQI has recently filed its Emergency Use Authorization (EUA) for RALI-DxTM IL-6 Severity Triage Test. The RALI-DxTM IL-6 Severity Triage Test and the RALI-fastTM IL- 6 Severity Triage POC Test each help clinicians identify which patients with SARS-CoV- 2 are predicated to have a severe inflammatory response and should or should not be admitted to the hospital. Both tests measure the critical biomarker IL-6 which plays a key role in the cytokine storm phase of the COVID-19 disease. RALI-DxTM delivers results from the lab in less than an hour while RALI-fastTM delivers results at the patient point- of-care in about 15 minutes. The Company currently expects to apply for an Interim Order from Health Canada for RALI-DxTM IL-6 Severity Triage Test in the second quarter and for RALI-fastTM IL-6 Severity Triage POC Test in the third quarter of calendar year 2021, respectively.
The COVID-19 HOME Antibody Test measures three antibodies of SARS-CoV-2 in individuals who have been infected with COVID-19, individuals who have been vaccinated or asymptomatic individuals wanting to know if they have been exposed. The test is > 99% accurate with results delivered in 24-48 hours. The Company is working towards an EUA for its COVID-19 HOME Antibody Test and collection kit in the second quarter of calendar year 2021. Should the COVID-19 HOME Antibody Test receive regulatory approval, the test is expected to be available as a direct-to-consumer product which would allow individuals to avoid travelling to a clinic or hospital to be tested for the presence of the SARS-CoV-2 antibodies.
In our organ transplant pipeline, SQI is pioneering an advanced diagnostic test that increases the chance of successful lung transplant by assessing the health of the donor organ prior to transplant surgery. The Company’s TORdxTM LUNG Test measures inflammation at the molecular level to assess the health of the donor lung, enabling surgeons to transplant healthy lungs which otherwise would have been rejected; there is currently no other such test. Upon receipt of regulatory approval of the TORdxTM LUNG Test, clinical development is planned for diagnostic tests designed to increase the chance of successful kidney and liver transplant.
SQI’s clinical research partner at University Health Network (UHN), is increasing the procurement, stabilization and transportation of healthy donor lungs available for transplant by supporting perfusion centers across North America. Implementation of Ex- Vivo Lung Perfusion (EVLP) procedures (FDA approved in 2019) has enabled lung transplant centers to increase the availability of donor lungs for transplant by nearly two- fold at some centers. Upon receipt of FDA market approval for the TORdxTM LUNG Test, SQI intends to leverage its product offering within the EVLP market and direct to transplant hospitals.
Our strategy of merging innovative diagnostics with differentiated health management services will enable us to provide comprehensive support for healthcare professionals, patients, and consumers across the globe.
The Company believes it has sufficient capital to operate and execute its business plan through the next two calendar quarters. Factors that will affect our future anticipated cash requirements include, but are not limited to, the infrastructure development for a US sales network, our clinical development and research activities and the regulatory decisions by the FDA and Health Canada.
What should have been included in the MD&A as notable subsequent to the quarter event here immediately below;
SQI Diagnostics Inc. and researchers from McMaster University were awarded a three-year, $900,000 collaborative research and development grant from the Natural Sciences and Engineering Research Council of Canada to develop new infection-testing technology to help detect critical, elusive markers of illness.
Designed as a coating for the lining of test tubes and other surfaces, the smart surface innovation improves the ability of diagnostic sensors to detect and measure the presence of cytokines, or proteins the body produces as part of its immune response, permitting more accurate measurement of infections such as COVID-19 and cancer.
This "smart surface" technology has significant implications that have yet to be fully described or valued. Just this one technology alone is worth multiples of the market cap of SQI today.
With four diagnostic FDA shots on goal scheduled over weeks and months ahead, any single approval will equal hundreds of millions in annual opportunity. Getting all four approved will provide an annual revenue opportunity in the Billions. High margin opportunities like these afford very rich evaluation models.
The key Directors that have determined SQI's flight path remain firmly in the pilot's seat. SQI's Science, Quality and Innovation has been in the making for over two decades and is ready for exploitation.
Most importantly, SQI remains largely in STEALTH mode, an untold/unshared story that has yet to be valued based on an informed market of integrity. This elusive yet simple task remains the responsibility of the B of D's, and is well past due.