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Quidel Corp. Gains FDA Clearance for 2 Diagnostic Tests

QUIDEL CORP.

President and CEO: Douglas Bryant.

Revenue: $113.3 million in 2010; $164.3 million in 2009.

Net loss: Net loss of $11.3 million for 2010; Net income of $32.9 million in 2009.

No. of local employees: 273.

Headquarters: Sorrento Valley.

Year founded: 1979.

Stock symbol and exchange: QDEL on Nasdaq.

Company description: A maker of pregnancy tests and other diagnostic health care products, many of which are sold under the QuickVue brand. Its tests are made primarily for use by medical professionals in doctor’s offices, hospitals, labs and clinics.

Key factors for success: The company has leading market share for its influenza diagnosis products and has built a large presence in tests for other respiratory conditions.

San Diego-based Quidel Corp. said the Food and Drug Administration has cleared the company’s first two molecular diagnostic tests for infectious diseases.

One of the tests screens for a respiratory disease called human metapneumovirus, and the other detects two variations of the influenza virus. The FDA reviewed the products under its 510(k) process for medical devices.

The timing of the clearances means that Quidel can begin marketing the tests in time to capture business from the 2012 flu and respiratory disease season, the company said on Dec. 23. In the United States, flu season occurs in the fall and winter, but typically peaks in February, according to the Centers for Disease Control and Prevention.

Quidel’s first molecular product is the Quidel Molecular hMPV Assay, which tests for a virus discovered in 2001 that most often infects young children, the elderly and others with weak immune systems.

Human metapneumovirus accounts for about 7 percent of children admitted to the hospital with respiratory infection, Quidel said, with symptoms sometimes indistinguishable from those caused by a virus called RSV, or human respiratory syncytial virus.

“We are very excited about the clearance of our first molecular offering in the United States,” said Quidel President and CEO Douglas Bryant.

The second product, the Quidel Molecular Influenza A+B Assay, “offers users a reliable, easy-to-use option for the diagnosis of influenza virus infections,” Bryant said.

Both products are part of the new Quidel Molecular product line, which sells disease-testing kits that molecular diagnostic labs can run on their existing equipment, the Applied Biosystems 7500 Fast DX thermocycler.

Quidel said the tests are designed for simple transport and storage, convenient workflow, and fast results. Both of the tests launched in Europe during the second half of 2011 after receiving the European Union’s CE Mark.

Although Quidel is taking action to broaden its product portfolio, its financial performance is still closely tied to the U.S. flu season. The company posted a net loss of $11.3 million in 2010, citing the absence of a flu season, compared with a profit of $32.9 million for the year earlier when the nation was dealing with a swine flu epidemic.

Quidel ranks 36th on the San Diego Business Journal’s list of Largest Public Companies with market capitalization of $415 million as of January 2011.

Most of Quidel’s diagnostic products — including its tests for influenza, strep and mononucleosis — are distributed under the QuickVue brand.

Quidel’s stock trades on Nasdaq under the symbol QDEL. Shares were at $15.50 on the morning of Jan. 4 — about midway between their 52-week high of $19.09 and 52-week low of $11.31.

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