AMDI Completes Clinical Study for Sub 10-minute Fast PCR System and Secures MDSAP Certification
SANTA ANA, Calif., June 5, 2025 /PRNewswire/ -- Autonomous Medical Devices Incorporated (AMDI), a developer of ultrafast PCR-based diagnostics, announced today the successful completion of its multicenter clinical study supporting FDA submission of its Mini Respiratory Panel. The respiratory panel is the first test developed for its Fast PCR system. In parallel, the company has obtained certification under the Medical Device Single Audit Program (MDSAP), a globally recognized framework for compliance with international quality and safety standards.
The Mini Respiratory Panel multicenter clinical study enrolled over 1,900 subjects to evaluate the performance of its ability to detect 4 of the most common respiratory pathogens: Flu A, Flu B, SARS-CoV-2 and RSV. The Fast PCR system is designed for CLIA-waived environments and delivers gold-standard RT-PCR results at the time of care: under 10 minutes.
"This dual achievement—completing our clinical study and earning MDSAP certification—represents significant progress on the commercial strategy for the company," said Dave Okrongly, Chief Executive Officer of AMDI. "It's a testament to the AMDI Team, the robustness of our technology, and the quality of the partnerships we have established. We are very excited about the clinical results and remain laser-focused on accelerating access to high-performance diagnostics at the time of care."
MDSAP certification, which is accepted by regulators in the United States, Canada, Brazil, Australia, and Japan, demonstrates that AMDI's quality management systems meet the stringent standards required for global market access. The certification was awarded following a comprehensive audit of AMDI's quality management processes, development and manufacturing operations.
"Achieving MDSAP certification affirms that AMDI's quality systems meet the highest international benchmarks," stated Aiying Sun, EVP of Quality, Regulatory & Clinical Affairs. "It reinforces our commitment to global compliance and positions us for streamlined regulatory engagement across key markets."
AMDI will submit its dual 510(k) and CLIA Waiver application for the Fast PCR system in the 3rd quarter of 2025. The Fast PCR system is the beginning of AMDI's broader vision to deliver rapid, reliable, and scalable molecular testing solutions for infectious diseases and other pressing diagnostic needs.
AMDI Media Contact:
Brian Miller
media@amdilabs.com
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SOURCE Autonomous Medical Devices Incorporated