Quidel Receives FDA Clearance for Its Hand-Held Molecular Diagnostic Test - AmpliVue(R) Group B Strep Assay

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 510(k) clearance from the United States Food and Drug Administration (FDA) for the sale of its AmpliVue Group B Strep Assay. AmpliVue is Quidel's non-instrumented molecular diagnostic test that employs a novel amplification technology with an easy-to-use, hand-held device. The AmpliVue Group B Strep Assay combines isothermal Helicase Dependent Amplification (HDA) with Quidel's well-established expertise in lateral flow technology to detect Group B Streptococcus (GBS) from enriched broth cultures of specimens from antepartum women.

 

GBS is responsible for illness in people of all ages, but it is a particularly serious pathogen for newborns in whom it can cause life-threatening sepsis, pneumonia and sometimes meningitis with a risk for long lasting effects, including deafness and developmental disabilities.¹ According to the Centers for Disease Control and Prevention (CDC), roughly 10% to 30% of pregnant women carry GBS that can be transmitted to the newborn at delivery. CDC guidelines recommend that all pregnant women should be tested for GBS infection between 35 and 37 weeks of pregnancy.²

Although more rare, serious GBS infections can also occur in adults, leading to bloodstream infections, pneumonia, and other infections that can be fatal.³

"We are pleased to receive 510(k) clearance for our AmpliVue Group B Strep assay," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "We can now provide the hospital laboratories with another AmpliVue assay for fast, accurate infectious disease testing without the need for additional investments in expensive equipment."

The AmpliVue Group B Strep assay now enables laboratories of all sizes to perform highly sensitive and specific molecular tests and is Quidel's second assay to launch in the hand-held, disposable AmpliVue format. The AmpliVue C. difficile assay was launched earlier this year for the detection of toxigenic Clostridium difficile bacterial DNA. Both assays are now available for sale throughout the U.S. and Europe. Diagnostic tests for other analytes of interest that will use the novel AmpliVue platform are in development.

¹http://www.cdc.gov/groupbstrep/about/index.html
²http://www.cdc.gov/groupbstrep/about/fast-facts.html
³http://www.cdc.gov/groupbstrep/about/adults.html

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 QuickVue®, D3® Direct Detection and Thyretain® leading brand names, as well as under the new Sofia® and AmpliVue® brands, Quidel's products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, influenza, respiratory syncytial virus, Strep A, 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 www.quidel.com and Diagnostic Hybrids at www.dhiusa.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 and changes in the buying patterns of our distributors; our development of new technologies, products and markets; our development and protection of intellectual property; 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 POC diagnostic products; changes in government policies; adverse actions or delays in product reviews by the U.S. Food and Drug Administration (the "FDA"); 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; the loss of key personnel; international risks, including but not limited to, compliance with product registration requirements, exposure to currency exchange fluctuations, 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; our failure to maintain adequate internal control over financial reporting; 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," and similar words, although some forward-looking statements are expressed differently. The risks described under "Risk Factors" in reports and registration statements that we file with the Securities and Exchange Commission (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 the forward-looking statements, except as required by law.

 

Contact:

Quidel
Quidel Corporation
Randy Steward
Chief Financial Officer
(858) 552-7931

Media and Investors
Quidel Corporation
Ruben Argueta
(858) 646-8023