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.
With the waiver we can now sell the Sofia test system to CLIA-waived physician office labs, emergency departments and other CLIA-waived facilities. What’s more, the newer claims eliminate the age limitation and extend the read time of the test, making the product even more flexible and accessible to patients and healthcare professionals alike. Our CLIA waiver allows for both walk-away and read now modes. Walk-away of course means that a test cartridge containing a patient specimen can be inserted into the instrument and the operator can walk away. In a read now mode, an operator can ink date multiple tests at a time and at any time within fifteen to thirty minutes, the operator can return and read results one right after the other in a read now mode that cycles every 45 seconds.
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