Selangor, 18 Jun 2025 – Reszon Diagnostics International Sdn. Bhd. (Reszon) is proud to share exciting news from our manufacturing partner, Chembio Diagnostics, Inc., that their innovative SURE CHECK® HIV Self-Test has received Breakthrough Device award from the U.S. Food and Drug Administration (FDA). This recognition marks a significant step forward in making HIV screening more accessible, timely, and user-friendly.
Designed for lay users, the SURE CHECK® HIV Self-Test is a simple, rapid, and fingerstick-based test that enables individuals to screen for HIV in the privacy of their own homes.
This is especially vital in addressing barriers such as stigma, limited healthcare access, and testing hesitancy that often delay diagnosis and treatment initiation.
The FDA Breakthrough Device Program is reserved for medical devices or device-led combination products that provide for more effective diagnosis or treatment of life-threatening or irreversibly debilitating diseases. With this designation, Chembio will benefit from prioritized FDA support and an accelerated review process, paving the way for faster approval and wider availability of the self-test across the U.S. and potentially globally.
As a proud distributor of the SURE CHECK® HIV Self-Test, we echo Chembio’s commitment to expanding early detection and empowering communities through self-testing. This breakthrough recognition validates the test’s high-impact potential in global HIV response strategies, especially among the underserved communities.
“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.”
“This FDA Breakthrough designation reinforces the reliability of the SURE CHECK® Self-Test, and its growing accessibility in Malaysia such as Alpro Pharmacy and Mega Kulim Pharmcy, brings us one step closer to empowering individuals worldwide to take control of their health”, said Katherine Koay, sales director at Reszon.
We remain committed to work together with Chembio in supporting public health initiatives, reducing late diagnoses, and ensuring that quality self-testing solutions like SURE CHECK® HIV Self-Test are available to those who need them most.
For distribution and order inquiries, or to learn more about the SURE CHECK® HIV Self-Test, contact us today.
About Chembio Diagnostic Systems, Inc
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.
Reference
Chembio Diagnostics. (2025). FDA Awards Breakthrough Device Status to the SURE CHECK® HIV Self-Test. Retrieved from https://hubs.ly/Q03stfnX0
