DDI’s One-Step Pregnancy Test Approved for Sale to Doctors : Medicine: Disease Detection International hopes next step is FDA authorization of over-the-counter sales by year’s end.
Disease Detection International Inc. said Wednesday that the Food and Drug Administration has approved the sale of its quick, one-step pregnancy test to hospitals and doctors’ offices, a move the company hopes will be a springboard for its entry into the lucrative over-the-counter market.
The new “ImmunoCard” test can detect a significant increase in a female hormone, Human Chorionic Gonadotropin, that begins at the start of pregnancy, said the Irvine-based company, which develops and manufactures a number of kits used to detect infectious and sexually transmitted diseases.
All a woman has to do is put drops of her urine into four small receptacles on a white, credit card-size device. In about five minutes, if she’s pregnant, four blue dots will appear on the device. This test is proven effective a day or two after a woman has missed her menstrual period, according to the company.
Since 1989, DDI has marketed a two-step pregnancy test through doctors’ offices and laboratories but it soon realized that the demand is higher for simpler, one-step test kits, H. Thad Morris, DDI’s president, said Wednesday.
The company’s sales tripled from $500,000 in 1989 to $1.5 million last year, but DDI said it lost $4 million during the two-year period. Morris blamed the the losses on start-up development costs for the 7-year-old company, which went public in 1987.
DDI, whose stock is traded over the counter, laid off half its 87 employees in June, 1990, when its lead subcontractor and East Coast distributor filed for bankruptcy. In April, it hired Cincinnati-based Meridian Diagnostics Inc. as its subcontractor and is negotiating with several minor distributors nationwide.
“We have a new distributor now and we’re recovering slowly from that experience which slowed us down,” Morris said.
The ImmunoCard, approved by the FDA since July 19, will be available to doctors and hospitals at the end of August and will sell for between $3 and $5, Morris said.
Morris hopes that DDI, which now has 38 employees, will get FDA approval to market the ImmunoCard directly to women through drugstores and supermarkets by the end of the year. Currently, all of DDI’s seven rapid-test products are approved for sale only in the professional market, which includes reference laboratories, hospitals and physicians’ offices. They include test kits for hepatitis and AIDS.
“This latest approval will broaden our product line and provide us with the opportunity to enter the over-the-counter market,” Morris said.
If approved for direct sales, the pregnancy device should retail between $8 and $12, he said.
The ImmunoCard is expected to compete with several one-step pregnancy test kits in what is considered a very lucrative market. Among them are Clear View, which is made by Unipath Co. in Mountain View, and Answer and First Response, made by New York-based Carter-Wallace Inc.