Quidel Corporation Receives FDA Clearance for Its New Solana® Molecular Assay for the Detection of Group B Streptococcal Infections
December 21, 2017 at 06:45 pm EST
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Quidel Corporation announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its Solana® GBS Assay for the direct, qualitative detection of Group B Streptococcus from enriched broth cultures of specimens from antepartum women. GBS is responsible for illness in people of all ages, but it is a particularly serious pathogen for newborns in whom the infection can cause life-threatening sepsis, pneumonia and sometimes meningitis with a risk for long lasting effects, including deafness and developmental disabilities. According to the Centers for Disease Control and Prevention (CDC), roughly 20% to 30% of pregnant women carry GBS that can be transmitted to the newborn at delivery. CDC guidelines recommend that all pregnant women should be tested for GBS infection between 35 and 37 weeks of pregnancy. Although more rare, serious GBS infections can also occur in adults, leading to bloodstream infections, pneumonia, and other infections that can be fatal. The Solana GBS Assay is an easy-to-use, molecular diagnostic test that generates an accurate result from either LIM or Carrot enrichment broth cultures of vaginal/rectal swabs from antepartum women following 18 to 24 hours of incubation. 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 different assays or patient samples in each batched run, and provides time-saving workflow advantages to healthcare professionals in moderately complex settings. The Solana instrumented system offers a comprehensive set of 510(k)-cleared assays that allows laboratories to quickly diagnose many diseases such as Influenza A+B, Strep Complete (Groups A+C/G), RSV+hMPV, HSV 1+2/VZV, Trichomonas, and C. difficile. The commercial introduction of Solana has broadened Quidel’s molecular strategy to include instrumented systems, and grown the number of its molecular platforms that are both 510(k) cleared and available commercially.
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.