Quidel Corp. announced Wednesday that it has receivedmarketing clearance from FDA for its one-step, one-minutehome pregnancy test, Conceive.
The test detects pregnancy as early as the first day of a missedperiod, the San Diego company (NASDAQ:QDEL) said. It's amonoclonal antibody-based assay that detects human chorionicgonadotropic hormone (hCGH) in urine, like all the other over-the-counter pregnancy tests now available to the consumer,said Mark Francois, Quidel's manager of investor relations. Butit's difference is in its simplicity and speed, he added.
The home pregnancy testing market is estimated at $158million in the U.S. For consumer diagnostics, it's second only toglucose testing for diabetes, at $195 million annually.
The Conceive One-Step Pregnancy Test is the companionproduct to Quidel's Conceive One-Step Ovulation Predictor Test,which the company has been marketing since last summer.
Quidel also markets a one-step pregnancy test for the doctor'soffice called QuickVue for which it received FDA approval inmid-December. QuickVue can detect pregnancy as early asthree days before a missed period, the company claims. --Jennifer Van Brunt
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