Camarillo Firm Gets FDA Approval to Sell Test Kit

Biopool International of Camarillo has received approval from the Food and Drug Administration to market a medical test kit that helps identify people at risk of developing blood-clotting disorders.

The Bioclot Protein S Assay, which has been used in clinical trials for about a year, is now available to hospitals, laboratories and other health-care providers.

Biopool manufactures chemicals to help diagnose blood, vascular and other disorders, as well as to detect drug abuse. The chemicals react with a patient’s blood to test enzyme levels, glucose levels, uric acid content and other indicators of a patient’s health.

Protein S is a natural anticoagulant, which helps regulate the body’s clotting process. Doctors have discovered that people with deficiencies of this protein are at risk of having clotting problems.

Biopool also makes kits that test for two other proteins--Protein C and Antithrombin III--that have similar anticoagulant effects.

“The Protein S test kit will allow physicians or labs to test anybody’s plasma to see if they have a normal or abnormal level of Protein S,” said Michael Bick, chairman and chief executive of Biopool.

“A lot of Biopool test kits fall into this category of being able to screen people for certain risk factors. This may be a $4 to $5 test. If people can identify the problem early, they can save tens of thousands of dollars in hospitalization and other medical related costs.”

Bick did not estimate the potential market for the Protein S test kits, but he said there are 300,000 to 600,000 hospitalizations in the United States annually for severe clot-related disorders.

Biopool reported net income of $484,902 on sales of $4,977,749 for the first three quarters of 1995, as compared with a net income of $549,198 on sales of $4,058,124 for the same period in 1994.