Innovative PCR Platform Delivers Sample-to-Result Molecular Testing Across All Laboratory Settings

QuidelOrtho Corporation’s (San Diego, CA, USA) innovative Savanna PCR platform is a cutting-edge diagnostic tool that allows professional users to test for up to 12 pathogens or targets and up to four controls in a single run, delivering results in approximately 25 minutes, depending on the specific assay. Savanna is a fully integrated, sample-to-result, automated in vitro diagnostic system that carries out real-time polymerization chain reaction (PCR) testing using the Savanna instrument alongside specific assay cartridges. The platform simplifies the testing process by managing everything from sample and reagent preparation to nucleic acid extraction and amplification, as well as the real-time detection of RNA or DNA target sequences, culminating in either a qualitative or quantitative analysis of the results. This is applicable to a range of sample types. Designed to assist in the precise and rapid diagnosis of related diseases, the Savanna multiplex molecular platform ensures accurate and quick patient diagnoses.

The U.S. Food and Drug Administration has granted QuidelOrtho 510(K) clearance for the Savanna PCR platform, along with its Savanna HSV 1+2/VZV in vitro diagnostic test. This test is specifically designed 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. These are isolated and purified from swabs taken from cutaneous or mucocutaneous lesion specimens in symptomatic patients. The FDA's clearance enables QuidelOrtho to market and sell the Savanna multiplex molecular platform and the Savanna HSV 1+2/VZV assay to laboratories in the United States that perform moderate or high complexity diagnostic testing.

“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 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,” added Bryant.

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