The AMDI Fast PCR System provides results for RSV, influenza, and COVID-19 in less than 10 minutes.
RT’s Three Key Takeaways:
- Rapid Diagnostic Results: The Fast PCR System delivers multiplex results in under 10 minutes to enable immediate clinical decision-making during patient visits.
- Regulatory Clearance: The FDA granted 510(k) clearance and a CLIA waiver for the 4-plex molecular panel and instrument.
- Clinical Utility: The system detects RSV, Influenza A, Influenza B, and SARS-CoV-2 simultaneously to help providers manage common respiratory pathogens in decentralized healthcare settings.
The FDA has granted 510(k) clearance and a CLIA waiver for the AMDI Fast PCR Instrument and Mini Respiratory Panel, according to Autonomous Medical Devices Inc.
The system is a multiplex RT-PCR test designed for the simultaneous detection and differentiation of Respiratory Syncytial Virus (RSV), Influenza A, Influenza B, and SARS-CoV-2 using anterior nasal swab specimens, according to the company. The Fast PCR System provides results in under 10 minutes, which the company states helps providers act within the “Time of Care” during urgent care and physician office visits.
“Pursuing the FDA’s dual 510(k) clearance and CLIA waiver pathway was a deliberate strategy to bring this innovation to market with the validation needed for clinical use in the urgent care setting,” said Aiying Sun, evp, quality, regulatory and clinical affairs at AMDI, in a news release. “It shows that Fast PCR combines strong RT-PCR performance with the simplicity needed for confident molecular testing at the point of care.”
The company has scaled manufacturing for both instruments and consumables at its facility in Santa Ana, California, to support deployment across decentralized healthcare settings.
“The AMDI Fast PCR System combines streamlined workflow with lab-quality molecular testing during the office visit, making it an ideal solution for urgent care and physician offices particularly those requiring RSV testing results,” said Brian Miller, evp of marketing at AMDI.
RSV remains a priority target for clinicians as it can cause significant disease in infants, older adults, and patients with underlying risk factors. In point-of-care settings, the rapid detection of RSV alongside other common respiratory pathogens can support more informed clinical decisions during a single visit.
“The AMDI Fast PCR fits naturally into the clinic workflow,” said Christopher Price, MD, clinical investigator at ERA Health Research, in a news release. “Staff can run the test without adding complexity, and getting a molecular result during the visit helps us make decisions while the patient is still in front of us instead of chasing follow-up later.”
The platform is built on proprietary technology with an architecture that allows for scalability up to 32-plex for future menu expansion, the company stated. The system also includes cloud connectivity and EHR integration to support deployment across distributed provider networks.
