SQI Diagnostics Inc., a life sciences and diagnostics company, has received notice that the United States Food and Drug Administration (FDA) has cleared the company to market its proprietary Celiac Panel in the United States (US).
“We are very excited to have received FDA clearance,” said Andrew Morris, CEO, SQI Diagnostics. “This clearance lays the foundation for sales in the US market of our newest in vitro diagnostic (IVD) autoimmune test.”
In addition to its suite of FDA cleared assays for celiac disease and rheumatoid arthritis, SQI is building a pipeline of other high-demand IVD autoimmune assays, including a quantitative 12-plex panel for lupus, a quantitative 3-plex panel for vasculitis, and an 8-plex panel for Crohn’s disease.
“Our revenue growth during the last fiscal year was achieved through the development of custom multiplexed assays for pharmaceutical companies and their clinical research organizations and most recently, molecular testing in the animal and human health markets. This clearance demonstrates the Company’s ability to achieve success in the third multiplexing market in which it is involved: IVD autoimmune test development,” said Morris. “The clearance is also an important element in marketing our products and services with leading global pharmaceutical companies, and diagnostic partners in our newest area of molecular testing.”
Celiac disease is a medical condition in which the absorptive surface of the small intestine is damaged by gluten, resulting in an inability of the body to absorb nutrients necessary for good health. According to the New England Journal of Medicine1, it is estimated that 1 in 100 people in the United States is affected by celiac disease.
The SQI Celiac Panel is an Ig_plex Celiac DGP in vitro diagnostic test for the semi-quantitative detection of the IgA and IgG immunoglobulin classes of antibodies to deamidated gliadin peptide (DGP) and tissue transglutaminase (tTG) in human serum. The test is intended for use in clinical laboratories as an aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings, and requires the use of a sqid-XTM system. The American Journal of Gastroenterology has reported that as many as 97% of celiac sufferers were undiagnosed. The 2013 American College of Gastroenterology guidelines and the American Gastroenterology Association recommend that tests for anti-tTG and anti-DPG should be part of routine testing for celiac disease.
Further, in a recent study by Health Quality Ontario, it was revealed that serologic testing for tTg has increased by 500% from 2004 to 20114.
SQI Diagnostics is a life sciences and diagnostics company that develops and commercializes proprietary technologies and products for advanced microarray diagnostics.