510(k) clearance granted for COVID-19 diagnostic PCR kit

Thermo Fisher Scientific has announced that its Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit has received 510(k) clearance from the US Food & Drug Administration (FDA). Initially introduced as an Emergency Use Authorized (EUA) test, the 510(k) clearance now allows clinical and public health laboratories to transition to an in vitro diagnostic (IVD) workflow. This marks a significant step in supporting the ongoing response to the COVID-19 pandemic.

Thermo Fisher Scientific remains committed to driving continuous innovation for its clinical customers. The 510(k)-cleared TaqPath COVID-19 Diagnostic PCR Kit is built upon the same chemistry as the EUA kit, which was used to test over one billion patient samples during the height of the COVID-19 pandemic. The kit is intended for use with nasopharyngeal and anterior nasal swab samples, and it includes all necessary assays and controls for real-time PCR detection of RNA from the SARS-CoV-2 virus. The multi-gene target design of the TaqPath COVID-19 Diagnostic PCR Kit, which includes the ORF1ab, N gene, and S gene, provides greater confidence in results and supports an accurate diagnosis as new mutations of the virus continue to emerge.

The TaqPath COVID-19 Diagnostic PCR Kit is designed for use in a range of settings, including reference and clinical laboratories, public health laboratories, and academic medical centres. With a proven track record of performance and reliability, the kit is validated for use on common PCR instruments in the United States. Building on the foundation of the emergency-use-authorised COVID-19 test, the 510(k)-cleared version ensures consistent performance and is ready for widespread use. Results can be delivered in as little as three hours, enabling care teams to make rapid, informed decisions and determine the best course of treatment for patients. Thermo Fisher’s continuous commitment to improving diagnostic solutions helps laboratories maintain high standards of accuracy and reliability in the ongoing battle against COVID-19.

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