Quidel Corporation (JOBS) Announces Joint Development and Commercialization Agreement with BioHelix

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SAN DIEGO, Calif. & BEVERLY, Mass.--(BUSINESS WIRE)--Quidel Corporation, a leading provider of rapid point-of-care diagnostic tests, announced today that it has entered into a joint development and commercialization agreement with BioHelix Corporation. The agreement with BioHelix focuses on the development and commercialization of in vitro molecular diagnostic tests utilizing BioHelix’s novel isothermal amplification technology.

The partnership combines BioHelix’s expertise in the research and development of nucleic acid technologies for diagnostic applications with Quidel’s strength in the development, manufacture and commercialization of diagnostic tests. Under the partnership, Quidel will fund and jointly develop with BioHelix assays for rapid detection of infectious pathogens in a non-instrumented, handheld format utilizing BioHelix’s isothermal amplification technology. BioHelix undertakes primary responsibility for assay development while Quidel has primary responsibility for manufacturing, marketing and selling the new products developed under the agreement and exclusive, worldwide commercialization rights for the new products.

“We are extremely pleased with this strategic partnership as both companies look to leverage their respective strengths in bringing novel diagnostic solutions to the clinical diagnostic market,” commented Douglas Bryant, president and chief executive officer of Quidel Corporation. Huimin Kong, Ph.D., president and chief executive officer of BioHelix Corporation, added, “We are excited to work with Quidel in the further development and commercialization of simple, cost-effective molecular diagnostic tests, which is a major focus for our company.”

About Quidel

Quidel Corporation serves to enhance the health and well being of people around the globe through the discovery, development, manufacturing and marketing of rapid diagnostic solutions at the point of care (POC) in infectious diseases and reproductive health. Marketed under the leading brand name of QuickVue®, Quidel’s portfolio of products currently includes tests that aid in the diagnosis of several disease or condition states, including influenza, respiratory syncytial virus, Fecal Occult Blood, Strep A, pregnancy, H. pylori and Chlamydia. Quidel's products are sold to healthcare professionals with a focus on the physician office lab and acute care markets through leading medical distribution partners on a worldwide basis. Quidel's Specialty Products Group (SPG) develops research products in the fields of oncology and bone health with potential future point-of-care applications. By building value in rapid diagnostic tests, Quidel provides leadership to the industry and among healthcare professionals allowing for the movement of patient testing out of the central laboratory setting and into the physician office, urgent care and other outpatient settings where rapid testing and treatment have an impact on clinical outcomes and provide an economic benefit. For more information, visit www.quidel.com, www.colorectal-test.com, www.rsvtesting.com and www.flutest.com.

About BioHelix

BioHelix Corporation, a privately held molecular diagnostics company located in Beverly, Massachusetts, specializes in the development of next-generation diagnostic solutions and nucleic acid tests based upon its isothermal nucleic acid amplification platform for infectious diseases and for genetic variations. BioHelix’s mission is to improve the quality of healthcare through the development of simple molecular tests for near patient settings, wherein rapid solutions are necessary for prompt medical intervention. The company's IsoAmp® Molecular Analyzer is an "instrument-free" molecular diagnostic platform consisting of its proprietary Helicase-Dependent Amplification (HDA) technology and a disposable detection device entitled the BESt™ Cassette. Additional information about BioHelix Corporation is available at www.biohelix.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. 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, seasonality, the timing of onset, length and severity of cold and flu seasons, the level of success in executing our strategic initiatives, uncertainty surrounding the detection of novel influenza viruses involving human specimens, adverse changes in the competitive and economic conditions in domestic and international markets, actions of our major distributors, technological changes and uncertainty with research and technology development, including any future molecular-based technology, the reimbursement system currently in place and future changes to that system, manufacturing and production delays or difficulties, adverse actions or delays in product reviews by the U.S. Food and Drug Administration, intellectual property, product liability, environmental or other litigation, required patent license fee payments not currently reflected in our costs, potential inadequacy of booked reserves and possible impairment of goodwill, and lower-than-anticipated sales or market penetration of our new products. 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 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 Corporation John M. Radak, Chief Financial Officer 858-646-8032 or Porter Novelli Life Sciences Pam Lord, 619-849-6003 plord@pnlifesciences.com

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