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      AMDI Receives NIH RADx® Tech Funding to Advance Its 10 Minute RT-PCR Point-of-Care System


      News provided by

      Autonomous Medical Devices Incorporated

      Apr 12, 2023, 11:59 ET

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      SANTA ANA, Calif., April 12, 2023 /PRNewswire/ -- 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. 

      Continue Reading

      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 announced today that it has been awarded Phase 1 funding from the NIH RADx® Tech program.

      Post this

      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.

      About AMDI 

      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.

      Contact: Brian Miller, [email protected]

      SOURCE Autonomous Medical Devices Incorporated

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      AMDI™ Fast PCR System Receives FDA 510(k) Clearance and CLIA Waiver for Sub-10-Minute Respiratory Panel

      AMDI™ Fast PCR System Receives FDA 510(k) Clearance and CLIA Waiver for Sub-10-Minute Respiratory Panel

      Autonomous Medical Devices Incorporated (AMDI) today announced that the U.S. Food and Drug Administration has granted both 510(k) clearance and CLIA...

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