Quidel Gains FDA Clearance for 2 Diagnostic TestsThursday, December 29, 2011
San Diego-based Quidel Corp. said the Food and Drug Administration has cleared the company’s first molecular diagnostic tests available in the United States.
One of the tests can identify a respiratory disease called human metapneumovirus, and the other detects two variations of the influenza virus. The timing of the clearances means that Quidel can begin marketing the tests in advance of the upcoming flu and respiratory disease season, the company said in statements on Dec. 23.
The FDA reviewed the products under its 510(k) process for medical devices. Both of the tests launched in Europe during the second half of 2011 shortly after gaining the European Union’s CE Mark.
Quidel said its first molecular product is Quidel Molecular hMPV Assay, which tests for a virus discovered in 2001 that most often infects young children, the elderly and others with a weak immune system. 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 different 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 Douglas Bryant, Quidel president and CEO.
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 Quidel Molecular product line, which sells disease-testing kits that molecular diagnostic labs can use with their existing equipment, the Applied Biosystems 7500 Fast DX thermocycler. Quidel said the products are designed for simple transport and storage, convenient workflow, and quick results.
Quidel has a wide product base with tests that cover an array of health conditions, from pregnancy to osteoporosis. The company’s shares, which trade on Nasdaq under the symbol QDEL, were at $15.25 on the afternoon of Dec. 28, down slightly from the prior day’s closing price.