Quidel Corp. said a recently issued U.S. patent covers thefoundation technology for the company's birth controldiagnostic products.
The patent, No. 5,118,630, determines the infertile period thatoccurs in women each month. The technology includes the useof immunoassays to detect urinary progesterone metabolitesand a cycle calendar to optimally identify the fewest daysrequired for testing. When concentrations of the hormonemetabolites reach or exceed threshold levels, a woman isconsidered to be in the post-ovulatory infertile period, andthus unlikely to become pregnant.
San Diego-based Quidel's (NASDAQ:QDEL) first product,SafePlan, is in U.S. consumer trials. SafePlan is designed tomeasure the hormone metabolite pregnanediol glucuronide(PDG) and indicate the safest time to have intercourse andavoid pregnancy.
A European release of SafePlan, pending the outcome of data inthe U.S. trials, is expected by March 1993, after which thecompany expects to apply for FDA approval in the U.S.
"To our knowledge, we are the only company working on rapidtype diagnostic tests for this purpose," said Mark Francois,manager of investor relations for Quidel.
"Our tests cater to women who cannot or prefer not to usechemical birth controls methods, such as the pill, the IUD andother methods," he said. "They provide an alternative methodof birth control that is non-invasive and comparably reliable."
The patent application was filed in November 1988 byMonoclonal Antibodies Inc., which merged with Quidel inJanuary 1991. Quidel develops rapid immunodiagnosticproducts that provide simple, accurate and cost-effectivediagnosis in the areas of human fertility, allergy, infectiousdisease and autoimmune disorders.
(c) 1997 American Health Consultants. All rights reserved.