BioSource to Manufacture Heart-Attack Test Kits

BioSource International Inc. of Camarillo has signed an agreement with The Pace Corp. of Canada, to be the exclusive manufacturer of a test kit that would enable emergency room doctors to determine more quickly and accurately the nature of a patient’s chest pain.

The BioSource kits would detect in the bloodstream a certain protein that medical studies have shown is an early indicator of myocardial infarction, a sudden reduction of blood flow to the heart. James Chamberlain, CEO of BioSource, said ELISA (Enzyme-Linked ImmuoSorbent Assay) kits should be completed this week for use in clinical trials in the United States, Europe, Japan and Canada. The Pace Corp. owns the marketing rights to the kit and will provide the antibodies necessary for the test.

Chamberlain said if the kits are approved for sale by the federal Food and Drug Administration, they could bring BioSource $2 million to $3 million annually. The Pace Corp. estimates that 7.6 million to 13.6 million tests would be given annually in the U.S. to the approximately 3.8-million patients who visit emergency rooms with chest pains.

“We are hoping to get this test in the format that gives a plus-minus type of result, like a home pregnancy test,” said Chamberlain. “Something quick and definitive. Should we operate or send the patient home with a Rolaids?”

Chamberlain said the ability to quickly determine whether chest pain is caused by a myocardial infarction would speed up treatment for severe cases, and cut down on unnecessary hospital stays for lesser cases.

“If we can send you home comfortably right away, instead of keeping you in the hospital two days while doctors follow you,” he said, “it would save a lot of money.”

BioSource manufactures about 35 different types of ELISA test kits, measuring different types of antigens. Antigens stimulate the production of antibodies within the bloodstream.