December 22, 2023- Quidel Corporation has received 510(K) clearance from the U.S. Food and Drug Administration for its innovative Savanna PCR platform and Savanna HSV 1+2/VZV in vitro diagnostic test for the detection and differentiation of Herpes simplex virus type 1 (HSV-1), Herpes simplex virus type 2 (HSV-2) and Varicella-zoster virus (VZV) nucleic acids isolated and purified from swabs obtained from cutaneous or mucocutaneous lesion specimens obtained from symptomatic patients.
The clearance allows QuidelOrtho to market and sell the Savanna multiplex molecular platform and the Savanna HSV 1+2/VZV assay to laboratories performing moderate or high complexity diagnostic testing in the United States.
The Savanna multiplex molecular platform enables professional customers to analyze up to 12 pathogens or targets, plus up to four controls, from a single test run in roughly 25 minutes, depending on the assay. Savanna is a fully integrated, sample-to-result, automated in vitro diagnostic platform that performs real-time polymerization chain reaction (“PCR”) tests by using the Savanna instrument and Savanna assay cartridges.
After inserting the customizable test panel cartridge, the instrument performs sample and reagent preparation, nucleic acid extraction and amplification, real-time detection of RNA or DNA target sequence, and qualitative or quantitative result interpretation from a variety of sample types. The Savanna platform is intended to aid in the diagnosis of related diseases, ensuring patients get the right diagnosis quickly and accurately.
The Savanna HSV 1+2/VZV test panel is intended to aid in the differential diagnosis of infections with these viruses. Savanna will be available to professional customers on December 20, 2023.