QuidelOrtho receives 510k clearance for Savanna PCR, HSV

QuidelOrtho Corporation has received 510k 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, Herpes simplex virus type 2 and Varicella-zoster virus 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.”