I’d like to update you on both. Sofia, as many of you know, is our next generation fluorescent immunoassay analyzer system and one of the cornerstones of our business. Our Sofia Analyzer and our Sofia Influenza A+B fluorescent immunoassay are now CE marked, 510-k cleared and CLIA waived. Although there have been some challenges around selling flu assays and analyzers to a limited audience in a weak flu season we’re seeing strong interest from customers and others in the scientific community who like the ease of use, connectivity aspects and enhanced assay sensitivity that the Sofia system provides.I’m pleased that just last week we received a CLIA waiver from the FDA for our Sofia fluorescent analyzer and our Sofia Influenza A+B assay for the detection of Flu A and B and nasal swab, and nasopharyngeal swab specimens from patients of all ages. Both of these simple-to-use tests employ Quidel-patented technology to yield an automated objective and a highly reliable result for aiding in the diagnosis of flu within minutes of obtaining the swab specimen from the patient. This is a significant milestone because the CLIA waiver designation allows us to penetrate more broadly the influenza diagnostic market, gaining access to the large physician office lab segment in addition to the hospitals, medical centers and smaller clinics that we already serve. This physician office lab segment accounts for the largest part of the approximately $270 million market for the rapid point of care tests that we manufacture currently.
Quidel's CEO Discusses Q1 2012 Results - Earnings Call Transcript
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