Quidel Receives FDA Clearance for its New Solana(R) Molecular Assay for the Detection of Clostridium difficile Infections
May 11, 2017 at 07:30 pm
Share
Quidel Corporation announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) to market its Solana® C. difficile Assay for the direct, qualitative detection of the Clostridium difficile DNA in unformed stool specimens of patients suspected of having Clostridium difficile-infection (CDI). Clostridium difficile is the most frequently identified enteric pathogen in patients with antibiotic-associated diarrhea and colitis. Per the Centers for Disease Control and Prevention (CDC), C. difficile was responsible for approximately half a million infections in the United States in 2011, with 29,000 patient deaths occurring shortly after the initial diagnosis. Clostridium difficile bacterial infections are life threatening, especially for the elderly, for the immunocompromised, and for patients on a prolonged antibiotic regimen. Typical CDI symptoms include nausea, fever, watery diarrhea and abdominal pain due to inflammation of the colon. Traditional methods for diagnosing CDI, such as glutamate dehydrogenase (GDH) or toxin antigen tests, can lack sensitivity and increase lab costs due to additional confirmation testing. In addition to significant technical expertise, cytotoxicity assays and toxigenic culture require 24 to 48 hours and 3 to 5 days, respectively, before reliable results can be obtained. The Solana C. difficile assay will now enable laboratories to offer a fast and sensitive result generated by molecular methods, without an upfront nucleic acid extraction step. The Solana C. difficile Assay is an easy-to-use, accurate, molecular diagnostic test that generates an accurate result in about 35 minutes. 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.
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.
QUIDELORTHO CORPORATION 
