Enable Biosciences Receives ANVISA Approval for ADAP T1Define™

SOUTH SAN FRANCISCO, Calif., Sept. 17, 2026 /CourierPR/ -- Enable Biosciences, a clinical reference laboratory and in vitro diagnostic (IVD) manufacturer based in South San Francisco, California, has achieved a significant milestone with the approval of its ADAP T1Define™ assay by Brazil's National Health Surveillance Agency (ANVISA). The approval, published in Brazil's Diário Oficial da União on July 6, 2026, classifies ADAP T1Define™ as a Class II in vitro diagnostic device, paving the way for its commercialization in Brazil.

ADAP T1Define™ is a multiplex islet autoantibody assay designed to analyze islet autoantibodies from dried blood spot specimens collected via a simple fingerstick or serum samples. This minimally invasive method of sample collection makes the test suitable for a variety of clinical settings, including primary care clinics, pediatricians' offices, and research institutions.

The development of ADAP T1Define™ was supported in part by a grant from the NIH National Institute for Diabetes and Kidney Disease (NIDDK) and Sanofi. The assay is intended for use in accordance with its authorized labeling in applicable jurisdictions, providing healthcare providers with a valuable tool for the early detection and monitoring of Type 1 diabetes.

Enable Biosciences, founded on a commitment to advancing autoimmune disease detection and monitoring, has been at the forefront of developing innovative diagnostic technologies. The company operates a CLIA- and CAP-certified clinical laboratory and maintains ISO 13485 certification for its quality management system. This latest approval by ANVISA is a testament to the company's dedication to improving patient care and expanding access to reliable diagnostic tools.

The approval of ADAP T1Define™ in Brazil is a significant step for Enable Biosciences, as it marks the company's entry into the Brazilian market. The South American nation has a large and growing population, presenting a substantial opportunity for the company to expand its reach and impact. With the approval in place, Enable Biosciences is poised to commercialize ADAP T1Define™, providing healthcare providers with a critical tool for the early detection and management of Type 1 diabetes.

The approval by ANVISA is part of a broader regulatory process that Enable Biosciences is currently undergoing in other jurisdictions. The company remains committed to advancing its diagnostic technologies and expanding its global footprint, with a particular focus on regions where early detection and management of autoimmune diseases are critical.

In summary, Enable Biosciences has achieved a significant milestone with the ANVISA approval of ADAP T1Define™, marking a critical step in the company's mission to improve patient care and expand access to reliable diagnostic tools. The approval in Brazil is expected to have a positive impact on the healthcare landscape, particularly in the early detection and management of Type 1 diabetes.