Quidel Corporation Receives FDA Clearance for its New Solana(R) Molecular Assay for the Detection of Herpes Simplex Virus 1+2 and Varicella Zoster Virus
November 29, 2016 at 03:00 pm
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Quidel Corporation announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) to market its Solana® HSV-1+2/VZV Assay for the qualitative detection and differentiation of herpes simplex virus type 1, herpes simplex virus type 2, and varicella-zoster virus DNA isolated and purified from cutaneous or mucocutaneous lesion samples obtained from symptomatic patients suspected of active herpes simplex virus 1, herpes simplex virus 2 and/or varicella-zoster infection. Quidel's Solana HSV-1+2/VZV Assay detects and differentiates herpes simplex virus type 1, herpes simplex virus type 2, and varicella-zoster virus from cutaneous or mucocutaneous lesion samples obtained from symptomatic patients. Specimens submitted in a broad range of transport media can be tested with the assay. The Solana HSV-1+2/VZV Assay is an easy-to-use, accurate, molecular diagnostic test that is compatible with many commonly used transport media, requires no upfront extraction of DNA and generates three accurate results in less than an hour. The Solana molecular platform leverages the Helicase-Dependent Amplification (HDA) technology that is resident in Quidel's AmpliVue® molecular product line to generate a fast and accurate test result. Solana can process up to 12 patient samples in each run, and provides time-saving workflow advantages to healthcare professionals in moderately complex settings. Solana® HSV-1+2/VZV is Quidel's fifth molecular diagnostic test to receive 510(k) clearance from the FDA in the scalable and versatile Solana format. Solana® Strep Complete received 510(k) clearance in October, Solana® Influenza A+B received 510(k) clearance in September, Solana® Trichomonas assay received 510(k) clearance in August, and the Solana® Group A Strep assay was cleared in June 2015. With the Solana franchise, Quidel has broadened its molecular strategy to include instrumented systems, and grown the number of its molecular platforms that are both FDA cleared and available commercially. Quidel's other FDA-cleared molecular solutions include the AmpliVue® non-instrumented system for lower-volume moderately complex labs and Lyra® reagents for higher throughput, highly complex laboratories that are compatible with existing PCR infrastructure. Solana® HSV-1+2/VZV Assay is not intended for use with cerebrospinal fluid or to aid in the diagnosis of HSV or VZV infections of the central nervous system (CNS). The Solana® HSV-1+2/VZV Assay is not intended for use in prenatal screening.
QuidelOrtho Corporation is engaged in vitro diagnostics, developing and manufacturing intelligent solutions. The Company sells its products directly to end users through a direct sales force and through a network of distributors, for professional use in physician offices, hospitals, clinical laboratories, reference laboratories, urgent care clinics, universities, retail clinics, pharmacies, wellness screening centers, other point-of-care (POC) settings, blood banks and donor centers, as well as for individual, non-professional, over the counter (OTC) use. The Company provides diagnostic testing solutions under various brand names, including AdenoPlus, BIOVUE, FreshCells, InflammaDry, Lyra, MeterPro, MicroVue, Ortho, Ortho Clinical Diagnostics, Ortho Connect, Ortho Plus, Ortho Vision, QuickVue, Quidel, QuidelOrtho, QVue, Savanna, Sofia, Solana, Thyretain, Triage, Virena, Vitros among others. It provides support for its customers across more than 130 countries and territories.
Quidel Corporation Receives FDA Clearance for its New Solana(R) Molecular Assay for the Detection of Herpes Simplex Virus 1+2 and Varicella Zoster Virus