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      AMDI Receives a $5.3M NIH RADx® Tech Award to Finalize Development of Its 10 Minute RT-PCR Point-of-Care System and Respiratory Panel


      News provided by

      Autonomous Medical Devices Incorporated

      Feb 28, 2024, 12:00 ET

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      SANTA ANA, Calif., Feb. 28, 2024 /PRNewswire/ -- Autonomous Medical Devices Incorporated (AMDI) has received a National Institutes of Health (NIH) RADx Tech award from the National Institute of Biomedical Imaging and Bioengineering (NIBIB), part of the NIH. Up to $5.2 million in funding will be used by AMDI to complete development of its Fast PCR System, a CLIA-waivable RT-PCR point-of-care system that can detect up to 32 targets per sample in less than 10 minutes. The funding will also be used to complete the first test panel for the Fast PCR system, targeting detection of multiple respiratory viruses: Influenza A and B, respiratory syncytial virus (RSV), and SARS-CoV-2.

      The RADx Tech program was created to speed innovation and address critical public health challenges like the COVID-19 pandemic. AMDI's selection of an additional award, after timely and successful completion of its previous award, underscores the continued market need and the potential of a cloud connected, multiplex point-of-care device.

      "AMDI is grateful for the recognition by the NIBIB for a second award that gives us the opportunity to complete the development of the Fast PCR System," said David Okrongly, CEO of AMDI. "Our market research indicates that our technology, when combined with cloud connectivity, can revolutionize patient care in the CLIA Waived setting."

      "The core of our system is the Hyperbaric Heating (HBH) sample prep technology combined with our ultrafast PCR chemistry. The HBH technology removes the time constraints and costs associated with traditional sample prep", said Regis Peytavi, CTO of AMDI. "Combining HBH with our ultrafast thermal cycling allows us to stay under 10 minutes regardless of the number of targets we put on the test disc."

      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) is a California company employing a world class team of engineers, scientists, clinicians, and manufacturing experts dedicated to the development and manufacture of best-in-class point-of-care diagnostic devices using innovative technology, factory automation, and cloud connectivity. AMDI is headquartered in Santa Ana, CA where it manufactures its test cartridges in an ISO:13485 certified 110,000 square foot facility.

      Media contact: Brian Miller
      media@amdilabs.com

      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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