Medical Device Network

AMDI scores $5.3m NIH grant for point-of-care viral testing

AMDI is developing a fast PCR panel that can detect up to 32 targets per sample in less than ten minutes, including respiratory viruses.

Autonomous Medical Devices Incorporated (AMDI) has received a National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) Tech award of up to $5.3m in financing to develop a fast polymerase chain reaction (PCR) system.

PCR is used to amplify a sample of DNA. It usually takes approximately an hour to complete and is commonly used for lab-based disease detection.

AMDI’s point-of-care PCR system is expected to detect up to 32 targets per sample in less than ten minutes. The company is also developing a fast PCR system for the detection of multiple respiratory viruses, including influenza A and B, respiratory syncytial virus (RSV), and SARS-CoV-2.

The use of point-of-care diagnostics has increased following the Covid-19 pandemic. The in vitro diagnostics market is expected to grow to be worth $38.5bn in 2030, as per a GlobalData market model. The infectious disease in vitro diagnostics market subsection is expected to be worth $14.2bn in the same period.

Multiple companies have developed point-of-care testing systems for a variety of purposes. Last month, Roche signed a definitive agreement to acquire LumiraDx’s point-of-care technology. Roche will pay a purchase price of $289m for the acquisition, along with an additional payment of up to $55m to fund operations of the point-of-care technology platform business until the acquisition closes. The deal is expected to close by mid-2024.

In December 2023, Ad Astra Diagnostics received 510(k) clearance from the US Food and Drug Administration (FDA) for its point-of-care QScout rapid-result haematology system. The solution can measure white blood cell counts (WBCs) and neutrophil-to-lymphocyte ratio, as well as differentiate the number and per cent of five types of mature WBCs, along with immature granulocytes.

The current NIH funding is the second one received by the company to develop its PCR point-of-care system. In April 2023, the company received $1.2m in financing from the National Institute of Biomedical Imaging and Bioengineering, part of NIH and responsible for disbursing the RADx Tech award.