AMDI Receives NIH RADx® Tech Funding to Advance Its 10 Minute RT-PCR Point-of-Care System
Santa Ana, CA
April 12, 2023 – Autonomous Medical Devices Incorporated (AMDI) announced today that it has been awarded Phase 1 funding from the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx®) Tech program in support of its RT-PCR Point-of-Care system. The initial award of $1.2M has the potential for Phase 2 funding pending successful completion of Phase 1. The RADx Tech award is funded by the National Institute of Biomedical Imaging and Bioengineering (NIBIB) and will help AMDI to support the continued development and validation of its novel molecular system as it moves toward product commercialization.
Originally launched in April 2020, the NIH RADx Tech program was created to speed innovation in the development of COVID-19 tests by providing funding and access to technical, regulatory, clinical, and commercial experts. In September 2022, another round of funding up to $300 million was announced to improve performance of over the counter (OTC) and point-of-care (POC) COVID-19 tests with a focus on universal design features to ensure ease of use, decrease the need for serial testing, and account for future variants. Products for this round must be ready for commercialization within 12-36 months.
AMDI’s RT-PCR POC system provides a 10-minute sample-to-result of up to 32 individual target sequences without the need for a separate, offline sample preparation. “We designed the AMDI ultrafast system to deliver highly sensitive, lab quality results with the accessibility needed to address the testing needs of both the current and future pandemics”, said Regis Peytavi, VP of Molecular Systems.
“We are grateful to receive this recognition and funding from the NIH and RADx Tech program. We feel this proprietary new product will allow public health officials to respond quickly to new variants and provide patients and their providers access to fast, high-quality molecular results”, said David Okrongly, CEO of AMDI.
This project has been funded in part with Federal funds from the National Institute of Biomedical Imaging (NIBIB), National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92023D00001.
Autonomous Medical Devices Incorporated (AMDI), with its principal place of business in California, employs a world class team of engineers, scientists, clinicians, and manufacturing experts dedicated to the development and manufacture of point-of-care diagnostic devices using breakthrough microfluidics, protein engineering, and data/cloud connectivity. AMDI will launch its first products from its ISO:13485 certified 110,000 square foot facility in Santa Ana, CA.
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.
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 less than 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.
Brian Miller firstname.lastname@example.org