QuidelOrtho Receives FDA Approval for Savanna® Multiplex Molecular Platform

QuidelOrtho has received US FDA 510(K) clearance for its innovative Savanna PCR platform and Savanna HSV 1+2/VZV assays 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 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 approximately 25 minutes. Savanna is a fully integrated, sample-to-result, automated IVD platform designed to aid in the diagnosis of related diseases, ensuring patients receive the right diagnosis quickly and accurately.

The Savanna platform’s small footprint hides a powerful set of features, such as integrated sample prep combined with rapid real-time PCR amplification and detection technologies, making it a perfect fit for syndromic testing in hospitals and moderate-complexity labs, with the goal of eventually accessing physician offices, urgent care clinics and other point-of-care locations,” said Douglas Bryant, President and CEO of QuidelOrtho.

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