Quidel
This article was originally published in The Tan Sheet
Executive Summary
Submits 510(k) application to FDA on Oct. 26 for its SafePlan OTC urine test, which is designed as an aid in pregnancy prevention by identifying the 10-to-15 days following ovulation in which a woman is non-fertile. The self-contained immunoassay cassette test, which measures a urinary metabolite of progesterone, takes just over five minutes and has demonstrated a 93%-to-95% rate of effectiveness in clinical tests involving more than 1,000 women, Quidel said. SafePlan will be sold in kits of two-to-four tests. The cost of a one-month supply is estimated at $ 8 to $ 15. Quidel will manufacture the test for Akzo, which has exclusive worldwide marketing rights to the test. Quidel is predicting a European launch as early as next spring.
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