NEW YORK – Enable Biosciences said on Tuesday that it has received a $3 million Phase IIB Small Business Innovation Research grant from the National Institute of Diabetes and Digestive and Kidney Diseases for its type 1 diabetes test.
The test detects type 1 diabetes autoantibodies in dried blood spot samples using the company's patented Antibody Detection by Agglutination-PCR (ADAP) technology, Enable said in a statement. The funding will be used to develop a comprehensive quality system to ensure the high-quality production of test components; evaluate the assay for consistency, sensitivity, and resistance to common interferences; and clinically validate the test. The firm intends to seek clearance from the US Food and Drug Administration for the assay.
"With this funding, we are a step closer to achieving FDA clearance for our ADAP technology, which is crucial in the context of new therapies capable of delaying [type 1 diabetes] onset," Jason Tsai, Enable's chief technical officer, said in a statement.
In a paper published in 2016 in ACS Central Science, the company's founders described ADAP as an "ultrasensitive solution-phase method for detecting antibodies." The antibodies "bind to and agglutinate synthetic antigen-DNA conjugates, enabling ligation of the DNA strands and subsequent quantification by qPCR," according to the publication.