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 Quidel Corporation QDEL, a provider of rapid diagnostic 
 testing solutions, cellular-based virology assays and molecular 
 diagnostic systems, announced today it has received 510(k) clearance and 
 Clinical Laboratory Improvements Amendments (CLIA) waiver from the 
 United States Food and Drug Administration (FDA) for Quidel's Sofia 
 Influenza A+B Fluorescent Immunoassay (FIA) to be used with the Sofia 2 
 Fluorescent Immunoassay Analyzer for the rapid, differential detection 
 of Influenza types A and B from direct nasal swab, nasopharyngeal swab, 
 and nasopharyngeal aspirate/wash specimens and nasopharyngeal swab and 
 nasopharyngeal aspirate/wash specimens in transport media from 
 symptomatic patients.
 
 
 Sofia 2 is Quidel's next-generation version of its best-selling Sofia 
 instrumented system. Sofia 2 utilizes the original Sofia's fluorescent 
 chemistry design while improving upon the graphical user interface and 
 optics system to provide an accurate, automated and objective result in 
 as few as 3 minutes. Sofia 2 also integrates wireless connectivity and 
 its barcode scanner within a smaller footprint than the legacy Sofia 
 instrument.
 
 
 The Sofia Influenza A+B assay employs advanced lateral flow and 
 immunofluorescence technologies to provide enhanced clinical sensitivity 
 for Influenza A or B infections. These features help ensure a reliable, 
 objective, rapid, and accurate diagnostic result. The Centers for 
 Disease Control and Prevention (CDC) estimates that flu-related 
 hospitalizations in the United States range from a low of 140,000 
 (during 2011-2012) to a high of 710,000 (during 2014-2015)1.
 
 
 In addition to the several thousand hospitals, medical centers and 
 smaller clinics in the United States, the receipt of CLIA waiver 
 markedly expands the available market for the Sofia 2 test system.
 
 
 "The Sofia 2 instrument is completely compatible with existing Sofia 
 test cartridges, has a modern graphical user interface, is portable and 
 small enough for exam rooms, can be connected to our cloud, and has an 
 integrated barcode scanner. From our perspective, Sofia 2's much lower 
 manufacturing cost is an important benefit, as it will allow us to place 
 instruments in an increased number of settings and to expand our reach," 
 said Douglas Bryant, president and chief executive officer of Quidel 
 Corporation. &#34;From the customer's perspective, we believe that the 
 biggest benefit for Sofia 2 users will be its ability to report a 
 positive test result in as little as three minutes, which will be a 
 significant help in managing patient workflow. Sofia 2 is expected to be 
 an important product for us moving forward as it has a number of 
 features that will be beneficial to an even larger set of existing and 
 new customers.&#34;
 
 
 1. <a xmlns="http://www.w3.org/1999/xhtml" href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.cdc.gov%2Fflu%2Fabout%2Fqa%2Fhospital.htm&amp;esheet=51566838&amp;newsitemid=20170530006124&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.cdc.gov%2Fflu%2Fabout%2Fqa%2Fhospital.htm&amp;index=1&amp;md5=fc2ceb2286e95eafa48369272001e6a6" rel="nofollow" rel="nofollow">https://www.cdc.gov/flu/about/qa/hospital.htm</a>
 
 
 About Quidel Corporation
 
 
 Quidel Corporation serves to enhance the health and well-being of people 
 around the globe through the development of diagnostic solutions that 
 can lead to improved patient outcomes and provide economic benefits to 
 the healthcare system. Marketed under the Sofia®, QuickVue®, D3® Direct 
 Detection, Thyretain® and InflammaDry® leading brand names, as well as 
 under the new Solana®, AmpliVue® and Lyra® molecular 
 diagnostic brands, Quidel&#39;s products aid in the detection and diagnosis 
 of many critical diseases and conditions, including, among others, <a xmlns="http://www.w3.org/1999/xhtml" href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.flutest.com%2F&amp;esheet=51566838&amp;newsitemid=20170530006124&amp;lan=en-US&amp;anchor=influenza&amp;index=2&amp;md5=ca24e1f5dafa77d6c99ac3c031166824" rel="nofollow" rel="nofollow">influenza</a>, 
 <a xmlns="http://www.w3.org/1999/xhtml" href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.rsvtesting.com&amp;esheet=51566838&amp;newsitemid=20170530006124&amp;lan=en-US&amp;anchor=respiratory+syncytial+virus&amp;index=3&amp;md5=b55473bc9827040b44f42173acb706e5" rel="nofollow" rel="nofollow">respiratory 
 syncytial virus</a>, Strep A, herpes, pregnancy, <a xmlns="http://www.w3.org/1999/xhtml" href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.thyretain.com%2F&amp;esheet=51566838&amp;newsitemid=20170530006124&amp;lan=en-US&amp;anchor=thyroid+disease&amp;index=4&amp;md5=5cd355e83723406da81375f8f4202ca6" rel="nofollow" rel="nofollow">thyroid 
 disease</a> and <a xmlns="http://www.w3.org/1999/xhtml" href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.colorectal-test.com%2F&amp;esheet=51566838&amp;newsitemid=20170530006124&amp;lan=en-US&amp;anchor=fecal+occult+blood&amp;index=5&amp;md5=28a3335c6545ed08da40b7668f5d6b7a" rel="nofollow" rel="nofollow">fecal 
 occult blood</a>. Quidel&#39;s research and development engine is also 
 developing a continuum of diagnostic solutions from advanced 
 lateral-flow and direct fluorescent antibody to molecular diagnostic 
 tests to further improve the quality of healthcare in physicians&#39; 
 offices and hospital and reference laboratories. For more information 
 about Quidel&#39;s comprehensive product portfolio, visit <a xmlns="http://www.w3.org/1999/xhtml" href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.quidel.com%2F&amp;esheet=51566838&amp;newsitemid=20170530006124&amp;lan=en-US&amp;anchor=quidel.com&amp;index=6&amp;md5=5212436bbc4bccc476ae4947a4b1d7d3" rel="nofollow" rel="nofollow">quidel.com</a>.
 
 
 This press release contains forward-looking statements within the 
 meaning of the federal securities laws that involve material risks, 
 assumptions and uncertainties. Many possible events or factors could 
 affect our future financial results and performance, such that our 
 actual results and performance may differ materially from those that may 
 be described or implied in the forward-looking statements. As such, no 
 forward-looking statement can be guaranteed. Differences in actual 
 results and performance may arise as a result of a number of factors 
 including, without limitation, fluctuations in our operating results 
 resulting from seasonality, the timing of the onset, length and severity 
 of cold and flu seasons, government and media attention focused on 
 influenza and the related potential impact on humans from novel 
 influenza viruses, adverse changes in competitive conditions in domestic 
 and international markets, changes in sales levels as it relates to the 
 absorption of our fixed costs, lower than anticipated market penetration 
 of our products, the reimbursement system currently in place and future 
 changes to that system, changes in economic conditions in our domestic 
 and international markets, the quantity of our product in our 
 distributors' inventory or distribution channels, changes in the buying 
 patterns of our distributors, and changes in the healthcare market and 
 consolidation of our customer base; our development and protection of 
 intellectual property; our development of new technologies, products and 
 markets; our reliance on a limited number of key distributors; our 
 reliance on sales of our influenza diagnostics tests; our ability to 
 manage our growth strategy, including our ability to integrate companies 
 or technologies we have acquired or may acquire; intellectual property 
 risks, including but not limited to, infringement litigation; our debt 
 service requirements; our inability to settle conversions of our 
 Convertible Senior Notes in cash; the effect on our operating results 
 from the trigger of the conditional conversion feature of our 
 Convertible Senior Notes; the possibility that we may incur additional 
 indebtedness; our need for additional funds to finance our operating 
 needs; volatility and disruption in the global capital and credit 
 markets; acceptance of our products among physicians and other 
 healthcare providers; competition with other providers of diagnostic 
 products; adverse actions or delays in new product reviews or related to 
 currently-marketed products by the U.S. Food and Drug Administration 
 (the "FDA"); changes in government policies; compliance with other 
 government regulations, such as safe working conditions, manufacturing 
 practices, environmental protection, fire hazard and disposal of 
 hazardous substances; third-party reimbursement policies; our ability to 
 meet demand for our products; interruptions in our supply of raw 
 materials; product defects; business risks not covered by insurance and 
 exposure to other litigation claims; interruption to our computer 
 systems; competition for and loss of management and key personnel; 
 international risks, including but not limited to, compliance with 
 product registration requirements, exposure to currency exchange 
 fluctuations and foreign currency exchange risk sharing arrangements, 
 longer payment cycles, lower selling prices and greater difficulty in 
 collecting accounts receivable, reduced protection of intellectual 
 property rights, political and economic instability, taxes, and 
 diversion of lower priced international products into U.S. markets; 
 dilution resulting from future sales of our equity; volatility in our 
 stock price; provisions in our charter documents, Delaware law and our 
 Convertible Senior Notes that might delay or impede stockholder actions 
 with respect to business combinations or similar transactions; and our 
 intention of not paying dividends. Forward-looking statements typically 
 are identified by the use of terms such as "may," "will," "should," 
 "might," "expect," "anticipate," "estimate," "plan," "intend," "goal," 
 "project," "strategy," "future," and similar words, although some 
 forward-looking statements are expressed differently. The risks 
 described in reports and registration statements that we file with the 
 Securities and Exchange Commission (the "SEC") from time to time, should 
 be carefully considered. You are cautioned not to place undue reliance 
 on these forward-looking statements, which reflect management's analysis 
 only as of the date of this press release. Except as required by law, we 
 undertake no obligation to publicly release the results of any revision 
 or update of these forward-looking statements, whether as a result of 
 new information, future events or otherwise.
 
 
 
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Press Releases

Quidel Receives FDA Clearance and CLIA Waiver for Its Point-of-Care Sofia® 2 Immunoassay Analyzer for Use with Sofia Influenza A+B Assay - QuidelOrtho (NASDAQ:QDEL)

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Quidel Receives FDA Clearance and CLIA Waiver for Its Point-of-Care Sofia® 2 Immunoassay Analyzer for Use with Sofia Influenza A+B Assay


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