SOURCE: Quidel

Quidel

March 17, 2015 13:15 ET

Quidel Receives FDA Clearance for Its AmpliVue Trichomonas Assay: A Hand-Held Molecular Diagnostic Test for Trichomoniasis

SAN DIEGO, CA--(Marketwired - Mar 17, 2015) - Quidel Corporation (NASDAQ: QDEL), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received clearance from the United States Food and Drug Administration (FDA) to market its AmpliVue Trichomonas Assay for the detection of nucleic acids isolated from clinician-collected vaginal swab specimens obtained from symptomatic or asymptomatic female patients. This molecular assay aids in the diagnosis of trichomoniasis, a sexually transmitted disease attributable to infection by the Trichomonas vaginalis parasite.

According to the Centers for Disease Control and Prevention (CDC), an estimated 3.7 million people in the United States have trichomoniasis. This disease is more common in women and, because only about 30% of those infected develop symptoms of trichomoniasis, most infected persons do not know that they carry the parasite.1  For pregnant women, Trichomonas infection is often associated with preterm delivery and low body weight in newborns. Genital inflammation is often associated with disease and can facilitate infection by other sexually transmitted pathogens, including HIV. Importantly, trichomoniasis can be cured with a single dose of antibiotics, emphasizing the need for rapid, highly sensitive tests that can detect this parasite and prompt immediate treatment.

The AmpliVue Trichomonas Assay is an easy-to-use, self-contained, handheld disposable molecular diagnostic test with superb clinical accuracy and with procedural steps consistent with those commonly seen in moderately complex laboratories. The assay requires no upfront extraction of DNA and generates an accurate result in approximately 50 minutes. Like other previously FDA-cleared AmpliVue assays, the AmpliVue Trichomonas Assay does not require the customer to invest in either expensive thermocycling equipment, or any other upfront testing costs. It is anticipated that minimal training will be required, as is the case with Quidel's other five in vitro diagnostic assays that use the AmpliVue platform. Using AmpliVue can therefore significantly lower a laboratory's cost to adopt and maintain the assay's unique molecular testing methods.

"Our AmpliVue Trichomoniasis Assay has shown excellent performance with samples from both symptomatic and asymptomatic patients. We believe that our test will play a critical role in quickly diagnosing this disease, creating opportunities for patient treatment and thereby limiting its spread," said Douglas Bryant, president and chief executive officer of Quidel Corporation.

Quidel's AmpliVue platform now enables laboratories of all sizes to perform highly sensitive and specific molecular tests. The AmpliVue Trichomonas Assay is Quidel's sixth molecular infectious disease assay to receive 510(k) clearance from the FDA in this hand-held, disposable AmpliVue format. In addition to Trichomonas Quidel offers 510(k)-cleared, in vitro diagnostic products on this novel platform for the diagnosis of six other pathogens: C. difficile, Group A Strep, Group B Strep, Pertussis, HSV1 and HSV2.

1) http://www.cdc.gov/std/trichomonas/stdfact-trichomoniasis.htm

About Quidel Corporation

Quidel Corporation serves to enhance the health and wellbeing 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 QuickVue®, D3® Direct Detection and Thyretain® leading brand names, as well as under the new Sofia®, AmpliVue® and Lyra® brands, Quidel's products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, influenza, respiratory syncytial virus, Strep, herpes, pregnancy, thyroid disease and fecal occult blood. Quidel'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' offices and hospital and reference laboratories. For more information about Quidel's comprehensive product portfolio, visit quidel.com.

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; the reimbursement system currently in place and future changes to that system; changes in economic conditions in our 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 quantity of our product in our distributors' inventory or distribution channels, changes in the buying patterns of our distributors and changes in the health care 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; limitations and covenants in our senior credit facility; that we may incur significant 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 US markets; volatility in our stock price; dilution resulting from future sales of our equity; and provisions in our charter documents and Delaware law that might delay stockholder actions with respect to business combinations or the election of directors. 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. We undertake no obligation to publicly release the results of any revision or update of these forward-looking statements, except as required by law.

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