Irvine Firm Wins Federal Approval for Fast, Simple on-a-Card Blood Tests : SCIENCE/TECHNOLOGY
Doctors seeking new services for their patients and new sources of revenue are being courted by Disease Detection International Inc.
The Irvine firm this week received approval from the U.S. Food and Drug Administration to market another new blood test that doctors can perform in their offices, instead of sending their patients’ blood to clinical laboratories.
According to Fred Horstman, Disease Detection International vice president of corporate planning, there is a growing market for such tests so that doctors can augment their traditional business.
In addition, Horstman said, patients benefit from having tests made in doctors’ offices where they can obtain quicker diagnosis and treatment than they would get if they had to wait for laboratories to send test results to their physicians.
Horstman said Disease Detection International hopes to be the first company to obtain FDA approval for a panel of four tests that obstetricians can administer in their offices to determine if pregnant women have immunity to diseases that can cause birth defects.
Horstman said the test approved by the FDA this week is to assess immunity to toxoplasma, a parasitic organism commonly found in the environment but especially associated with cats and uncooked pork products. In addition, he said the company received FDA approval a month ago to market a test for immunity to German measles. These are the first human diagnostic tests the company has begun to market. The 3-year-old company previously developed veterinary diagnostic tests.
All of the tests, Horstman said, are performed on plastic cards embedded with membranes, on which the doctors place a drop of blood and reagents supplied in the test kits. If a blue spot appears, it means that the patient has immunity.
Disease Detection International expects to sell the tests to doctors at a price of about $3 per card. Company officials expect that doctors in turn will charge their patients about $20 for each test, or about the same that a clinical laboratory would charge.
