Quidel Corp (QDEL) Granted FDA 510(k) Clearance for New Solana Molecular Assay

November 29, 2016 10:03 AM EST

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Quidel Corporation (NASDAQ: QDEL) 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.

The Centers for Disease Control and Prevention (CDC) estimates that there are almost 800,000 new cases of herpes in the United States each year, and about 1 in 6 Americans aged 14 to 49 have a genital HSV-2 infection. 1 An estimated 87.4% of 14-49 year olds infected with HSV-2 have never received a clinical diagnosis. According to the CDC, transmission of HSV-2 most commonly occurs from an infected partner who does not have visible sores and who may not know that he or she is infected.

Herpetic lesions can be a result of the primary infection by the virus or from a reactivation of the latent virus, causing recurrent episodes of the disease. HSV-1 and HSV-2 are genetically and antigenically distinct forms of HSV. HSV-2 is the most common cause of genital infections, due to venereal transmission; HSV-1 is commonly associated with other disease locations although both serotypes have been shown to cause disease in all locations of the body.

Varicella-zoster virus (VZV) is a DNA virus of the family Herpesviridae. Primary VZV infection results in chickenpox (varicella), which rarely results in complications including encephalitis or pneumonia. Even when clinical symptoms of chickenpox have resolved, VZV remains dormant in the nervous system of the infected person (virus latency). In approximately 10 to 20% of cases, VZV reactivates later in life, producing shingles.

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.

"Quidel has long been a leader in developing innovative Respiratory and Women's Health assays. Our latest product introduction, the Solana® HSV-1+2/VZV assay, broadens our molecular diagnostic offerings for Women's Health assays in the moderately complex setting," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "We believe that the Solana platform will provide the laboratorian with a fast and accurate method to diagnose many Women's Health conditions, including shingles, herpes, and trichomonas infections."

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.

1 http://www.cdc.gov/std/Herpes/STDFact-Herpes.htm



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