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QuidelOrtho Gets FDA 510(k) Clearance for Savanna MDx System, HSV Test

NEW YORK — QuidelOrtho said on Wednesday that it has received 510(k) clearance from the US Food and Drug Administration for its Savanna PCR-based molecular diagnostics system, as well as for a herpes simplex virus (HSV) assay that runs on the instrument.

Savanna, which has been in development since around 2011, is a fully integrated, sample-to-result, automated system designed for the analysis of up to 12 pathogens or targets, plus four controls, in a single test cartridge by real-time PCR. The newly cleared Savanna HSV 1+2/VZV test panel is designed to detect and differentiate HSV-1, HSV-2, and varicella-zoster virus nucleic acids obtained from cutaneous or mucocutaneous lesion specimens.

The platform, along with a four-target syndromic respiratory virus panel called RVP4, is already CE marked in Europe. QuidelOrtho said last month that it has already manufactured instrument inventory in anticipation of the FDA clearance. Savanna is now available to US customers, according to the firm.

"The Savanna platform's … features, such as integrated sample prep combined with rapid real-time PCR amplification and detection technologies [make] 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," QuidelOrtho President and CEO Douglas Bryant said in a statement.