Data Highlights the Quantitative Detection of Neutralizing Activity Against Multiple SARS-CoV-2 Variants in Less Than 20 Minute Q-NAb Test

Santa Ana, CA

September 20, 2022 - Autonomous Medical Devices Incorporated (AMDI) announced today that it will be presenting data on its Q-NAb™ Test at the 28th AACC International CPOCT Symposium: Meeting Evolving Patient Needs Using Point-of-Care Testing in Montreal September 21-23, 2022. The poster presentation is titled "Ultra-fast Quantitative Detection of Neutralizing Activity Against Multiple SARS-CoV-2 Variants".

"Today, measurement of the neutralizing antibody response to COVID-19 vaccines requires live virus testing in a BSL-3 laboratory. We are excited to show data demonstrating that the new Autolab-20TM and Q-NAb Test can quantitate the levels of neutralizing antibodies against all known strains of SARS-CoV-2 and are highly correlated with neutralization as measured by a live virus assay." said Dr. Sasha Perebikovsky, VP of Immunochemistry Systems.

"AMDI is proud to present performance data on its first product, the Q-NAb test. The ability to routinely measure quantitative neutralization activity in a sample has important research utility and may be important in patient management. We are preparing to launch the Q-NAb Test as an RUO in 2023 as we gather additional information needed to seek authorization of the Q-NAb test as a diagnostic product" explained David Okrongly, CEO of AMDI.

AMDI Achieves ISO 13485:2016 Certification In Anticipation of Commercializing Products in 2023.

Santa Ana, CA.

September 7, 2022 - Autonomous Medical Devices (AMDI) announced today the certification of its Quality Management System to ISO 13485:2016 by Intertek. This certification is an important milestone, particularly as the Company prepares for commercialization of its first rapid, point-of-care diagnostics platform.

“We are proud to receive this ISO certification. At AMDI, Quality is built into every process and embraced by every employee,” said Aiying Sun, VP Quality Assurance and Regulatory Affairs.

ISO 13485:2016 specifies requirements for an organization's Quality Management System to demonstrate its ability to provide medical devices and related services that consistently meet customer needs and applicable regulatory requirements.

“The ISO certification is an important recognition of AMDI's commitment to develop and manufacture high quality diagnostic products using our breakthrough technology,” explained David Okrongly, CEO of AMDI.

About AMDI

Autonomous Medical Devices Incorporated (AMDI) is an early-stage, California company focused on developing and manufacturing Autolabs and their associated test discs for human clinical diagnostics. Each of AMDI's Autolabs are small, portable point-of-care diagnostics devices using breakthrough microfluidics, hardware, and data/cloud connectivity to deliver lab quality results in <15 minutes. AMDI has built a world class, multi-disciplinary team of engineers, scientists, clinicians, and database experts and will launch its first Research Use Only (RUO) products in 2023 from its 110,000 square foot facility in Santa Ana, CA.

Media Contact

Brian Miller