Enable Biosciences Announces ANVISA Approval of ADAP T1Define™ for Type 1 Diabetes Autoantibody Testing in Brazil

SOUTH SAN FRANCISCO, Calif., Sept. 17, 2026 /PRNewswire/ -- Enable Biosciences, Inc., a clinical reference laboratory and in vitro diagnostic (IVD) manufacturer, today announced that Brazil's National Health Surveillance Agency (ANVISA) has approved ADAP T1Define™, the company's multiplex islet autoantibody assay that uses a fingerstick dried blood spot or serum specimen. 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.

The ANVISA authorization permits commercialization of ADAP T1Define™ in Brazil for its approved intended use. The assay is designed to analyze islet autoantibodies from a dried blood spot specimen collected by fingerstick or serum samples, providing a minimally invasive sample collection method suitable for a variety of clinical settings.

"This milestone is the result of eight years of foundational research," said David Seftel, MD, MBA, CEO of Enable Biosciences. "This is a meaningful step toward giving families around the world critical answers and better options for improved care."

Support for the study was provided in part by grant 2 R44 DK111005-04 to Enable Biosciences from the NIH National Institute for Diabetes and Kidney Disease (NIDDK) and from Sanofi.

About ADAP T1Define™

ADAP T1Define™ is a multiplex islet autoantibody assay that utilizes a fingerstick dried blood spot or serum specimen. The test is intended for use in accordance with its authorized labeling in applicable jurisdictions.

About Enable Biosciences

Enable Biosciences, Inc. is a clinical reference laboratory and in vitro diagnostic manufacturer headquartered in South San Francisco, California. The company develops laboratory and diagnostic technologies focused on autoimmune disease detection and monitoring. Enable Biosciences operates a CLIA- and CAP-certified clinical laboratory and maintains ISO 13485 certification for its quality management system.

Forward-Looking Statements

This press release contains forward-looking statements regarding anticipated regulatory activities and potential commercialization of ADAP T1Define™ in jurisdictions outside Brazil. These statements are based on current expectations and are subject to risks and uncertainties associated with regulatory review and other factors. Regulatory approvals outside Brazil are under review by the applicable authorities.

Media Contacts
Enable Biosciences, Inc
David Seftel
650-240-3105
[email protected] 

SOURCE Enable Biosciences Inc