Medford N.Y USA/Strasbourg France – June 17, 2025 – Chembio Diagnostic Systems, Inc., a subsidiary of Biosynex, developer and manufacturer of rapid diagnostic tests, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device status to the SURE CHECK® HIV Self-Test.
The SURE CHECK® HIV Self-Test is a rapid, single-use immunochromatographic test designed to detect antibodies to HIV-1 and HIV-2 viruses using a simple fingerstick blood sample. It is intended for over-the-counter (OTC) or online sale for use by individuals aged 14 and older in private settings, making it a simple and accessible solution for people who may have come into contact with HIV or been exposed to risky situations.
The product is currently in the final stages of clinical validation prior to regulatory submission to the FDA and commercialization in the U.S. market.
“This FDA recognition is a significant milestone for Chembio, underscoring our commitment to expanding access to effective and rapid HIV tests for all, particularly populations at high risk or with limited access to care,” said Steven Sepulveda, Chief Strategy Officer at Chembio Diagnostics. “We are confident that the SURE CHECK® HIV self-test will play a key role in the early detection of HIV infection as part of a prevention and public health approach aimed at reducing HIV transmission, by allowing individuals to test themselves in the privacy of their own homes.”
“The SURE CHECK® HIV self-test utilizes our immunochromatographic platform, which offers high clinical sensitivity and specificity in a simple, user-friendly format ideal for lay users,” said Javan Esfandiari, President of Chembio Diagnostics. “This FDA recognition validates both the diagnostic value of our technology and its potential to expand access to HIV testing. This test was designed with the same performance requirements as tests intended for professionals, while ensuring ease of use and simplicity of reading in home environments.”
The Breakthrough Devices program is designed to make innovative medical devices of public health interest available to patients and healthcare professionals as quickly as possible. This FDA recognition provides Chembio with the opportunity for expedited interactions with the FDA to prioritize market access for its product.
The FDA’s Breakthrough Device Program is designed to expedite the development and regulatory review of technologies that provide diagnostic or therapeutic benefits.
Chembio will continue to work closely with the FDA for the commercialization of the SURE CHECK® HIV self-test in the United States.
Chembio Diagnostic Systems, Inc., a subsidiary of the Biosynex Group, is a leading diagnostics company focused on developing, manufacturing, and commercializing point-of-care tests for infectious diseases. The company’s proprietary DPP® technology platform delivers high-quality, accurate results in minutes, supporting timely diagnosis and improved patient outcomes around the globe. Biosynex’s global diagnostics portfolio also includes other innovative companies such as Qualigen and ProciseDx – each contributing to its mission of delivering the results you need when it matters most.
Chembio Contacts:
Javan Esfandiari
President
[email protected]
Steven Sepulveda
Chief Strategy Officer
[email protected]
