SQI Diagnostics Expanding Business into Rapid Diagnostic Testing Market - Seite 2

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.