Enable Biosciences Gains Brazil Approval for T1D Test

South San Francisco, California, U.S., September 17, 2026

ANVISA Approval Expands Access to T1D Testing

The ANVISA approval provides regulatory authorization for ADAP T1Define to be marketed in Brazil according to its approved labeling. The assay is designed to analyze islet autoantibodies, which are important biomarkers associated with the autoimmune process underlying Type 1 diabetes. Unlike conventional testing approaches that may require conventional blood collection, ADAP T1Define can use a fingerstick dried blood spot (DBS) specimen or a serum sample. This minimally invasive sample-collection approach could support testing across a variety of clinical settings while providing flexibility in how specimens are obtained and processed.

Enable Biosciences describes ADAP T1Define as a multiplex islet autoantibody assay, meaning the platform is designed to evaluate multiple autoantibody markers through a single testing approach. The company has developed its broader ADAP technology around highly sensitive antibody detection and has previously highlighted applications in Type 1 diabetes screening. Its current product information notes that autoantibody markers can appear before symptoms of Type 1 diabetes, making antibody testing relevant to identifying individuals who may be at risk for disease progression.

ADAP Technology Supports Early Autoantibody Detection

The regulatory milestone is particularly relevant to efforts focused on earlier identification of Type 1 diabetes risk. Type 1 diabetes is an autoimmune disease in which the immune system attacks insulin-producing pancreatic cells. The appearance of multiple islet autoantibodies can provide an indication that the autoimmune process is underway before the development of symptomatic diabetes. Enable Biosciences has developed its ADAP platform to detect antibodies and has applied the technology to clinical diagnostic testing.

The company currently operates a CLIA- and CAP-certified clinical laboratory and states that it maintains ISO 13485 certification for its quality management system. Its laboratory uses ADAP technology for diagnostic testing, while its research and development activities focus on expanding applications and improving existing assays. Enable Biosciences has also incorporated automation into its laboratory operations to support higher-throughput processing. The company said the development behind ADAP T1Define represents eight years of foundational research. Support for the study was provided in part through an NIH National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) grant and funding from Sanofi, according to Enable Biosciences.

Brazil Commercialization Marks International Expansion

With the Brazilian authorization, ADAP T1Define becomes available for commercialization in another national regulatory market, extending the potential reach of Enable Biosciences’ Type 1 diabetes diagnostic technology. The company said the authorization represents a step toward providing families with access to additional diagnostic options for Type 1 diabetes-related autoantibody testing. The company has also indicated that regulatory activities involving jurisdictions outside Brazil remain subject to review by the applicable authorities. Enable Biosciences cautioned that statements concerning future regulatory approvals and commercialization outside Brazil are forward-looking and involve regulatory and other uncertainties. Therefore, the ANVISA authorization should be distinguished from any potential future approvals in other markets.

The approval of ADAP T1Define™ in Brazil adds an important regulatory milestone to the development of Enable Biosciences’ diagnostic portfolio. By combining multiplex islet autoantibody analysis with fingerstick dried blood spot or serum specimens, the technology is positioned for use within the company’s broader efforts to advance autoimmune disease detection and monitoring.

Source: Enable Biosciences press release