advanced diagnostic test that increases the chance of succes About SQI Diagnostics
SQI Diagnostics, Inc. is a precision medicine company that discovers, develops, manufactures and commercializes innovative rapid diagnostic testing for healthcare providers, patients and consumers worldwide. The Company’s proprietary advanced diagnostics target organ transplant, autoimmune disease and serological testing, which include a developmental COVID-19 Patient Triage Test (RALI-Dx™) and a direct-to-consumer COVID-19 Antibody Test Kit. SQI’s rapid diagnostic tests are sold to healthcare professionals so that patients can get accurate results and fast effective treatment, and direct-to-consumers so that individuals can take action to improve their health outcomes from the comfort of their home.
Under organ transplant, SQI is pioneering the development of 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 TORdx™ Lung Test can detect inflammation at the molecular level enabling surgeons to make a “go” or “no-go” decision on initiating transplantation; there is currently no other such test. SQI has partnered with University Health Network (UHN) Hospitals, one of the largest health and medical research organization in North America, for the TORdx™ Lung Test clinical development program. SQI is working with agencies in both the U.S. and Canada to submit the TORdx™ Lung Test for regulatory approval. Additional diagnostic tests designed to increase the chance of successful organ transplant for the kidney and liver are planned for clinical development post-regulatory approval of the TORdx™ Lung Test.
Under autoimmune disease testing, SQI has a direct-to-consumer Celiac Disease and a Rheumatoid Arthritis (RA) Test that enable people to screen for the diseases from the comfort of their home. The direct-to-consumer RA Test can help identify and confirm RA symptoms for early care. The direct-to-consumer Celiac Test is the only test that confirms the disease and that can also validate the effectiveness of dietary and lifestyle changes to confirm the autoimmune response is improving.
Under serological testing, SQI is fast-tracking the development of a direct-to-consumer COVID-19 At-home Antibody Test Kit to detect the presence of SARS-CoV-2 antibodies in the blood. The Covid-19 Antibody Test Kit will determine if someone has been exposed to the SARS-CoV-2 virus and the degree of exposure and possible immunity to it. SQI’s COVID-19 Antibody Home Test Kit will be highly accurate >98%. The Company intends to apply for FDA Emergency Use Authorization (“EUA”) for its COVID-19 Antibody Test Kit. If EUA is obtained, this test could be the first or one of the first antibody tests shipped direct to the consumer home or business so individuals won’t have to travel to a clinic or hospital to be tested for the presence of SARS-CoV-2 antibody.
SQI is also fast-tracking the development of a COVID-19 Triage Test called the RALI-Dx™. The RALI-Dx™ test is an Inflammatory Response Panel comprised of several biomarkers indicative of the “cytokine storm” that is associated with acute lung injury. The RALI-Dx™ delivers results in under an hour, giving the clinician insight into whether a patient with COVID-19, Flu or any upper respiratory condition, can be treated and released for home care, should be admitted to a standard hospital unit to be monitored, or is likely to develop severe life-threatening symptoms and requires immediate intensive care unit (ICU) admittance and advanced respiratory care measures. The ability to effectively triage COVID-19 (or Flu) patients would be a diagnostic industry first. The Company intends to apply for FDA EUA for its COVID-19 Triage Test.