DDI Wins FDA Approval to Market Pregnancy Test

Disease Detection International Inc. said it has received Food and Drug Administration approval to begin marketing a pregnancy test based on a technology that is at the root of a dispute between the Irvine-based company and its former parent, Environmental Diagnostics Inc.

The test--which can be performed in doctors’ offices, hospitals or medical labs--is one of five DDI diagnostic tests that will be marketed for the next five months by the Du Pont Co. under an interim distribution agreement expected to bring DDI about $500,000 in sales through December.

All five of the tests are based on what DDI says is a new technology that it developed.

Environmental Diagnostics, however, maintains that DDI’s process is merely an improvement of a technology that DDI has used under license from Environmental Diagnostics. The North Carolina firm has launched a proxy contest in which it is seeking to replace all five current DDI directors.

While that contest continues, Environmental Diagnostics alleges that DDI has no right to market products.

A spokesman for Du Pont said the marketing agreement with DDI has not been affected by the dispute with Environmental Diagnostics.

He said Du Pont is “very interested” in DDI’s diagnostic tests, which enable doctors to use a few drops of a patient’s blood to determine immunity to such diseases as rubella, or German measles, and two forms of herpes.

Other tests require the use of whole blood, which must be processed in a medical lab, increasing both the cost and the time it takes to obtain a diagnosis.