QuidelOrtho Receives 510(K) Clearance for Savanna® Multiplex Molecular Platform and Savanna® HSV 1+2/VZV PCR Assay

Original from: business wire

QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, 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.

“Our relentless pursuit of revolutionizing testing across the healthcare continuum has resulted in the achievement of another major milestone – the clearance of our Savanna platform and the Savanna HSV 1+2/VZV assay,” said Douglas Bryant, President and Chief Executive Officer of QuidelOrtho. “We’re truly differentiating diagnostics in the marketplace and allowing labs and healthcare workers to provide the quick diagnoses needed in critical situations.”

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 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. Savanna is a truly compelling product, our next flagship platform and an important growth driver,” said Bryant.

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.

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Source: QuidelOrtho Receives 510(K) Clearance for Savanna® Multiplex Molecular Platform and Savanna® HSV 1+2/VZV PCR Assay