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Simple, Inexpensive Pcb And Dioxin Tests On The Horizon

BT Catalyst, Jan, 2000

HYBRIZYME WORKING TO VALIDATE TESTING KITS IN EUROPE AND JAPAN

There are a few proven ways to take your company's products and services to Europe and the Far East. One approach may be to methodically develop contacts and name recognition over time with a dedicated sales force.

But there is another less common approach: spring into action when a catastrophe or market condition arises.

Hybrizyme Corp. of Raleigh employed the later approach last year as food contamination threatened Belgium and surrounding countries, forcing the closure of about 1,000 farms that received animal feed tainted with polychlorinated biphenyls (PCBs) and traces of dioxins.

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Since there weren't any quick and inexpensive tests on the market at the time to determine toxicity levels, Hybrizyme moved in on the opportunity to validate its immunoassay for the speedy detection of PCBs in animal fat, cooking grease and animal feed.

PCBs and dioxins are chemicals released into the environment mostly through incineration and manufacturing processes. These chemicals are so common in the environment that they typically end up being ingested in minute amounts by humans and animals and stored in fatty tissues.

In Belgium, however, the PCB/dioxin contamination was linked specifically to animal-fat storage tanks that were not sufficiently cleaned after being used to hold mineral and industrial oils.

Exposure to these chemicals have been linked to cancer, harmful reproductive and developmental defects, immunotoxicity, diabetes and endometriosis. However, significant epidemiological data on human toxicity has been limited partly because of the lack of a simplified, inexpensive method of assessing harmful levels of exposure.

Founded in 1995 by CEO Randy L. Allen, Hybrizyme has an exclusive, worldwide license to a patented and proprietary assay system that accurately measures these chemicals using human Ah receptors.

"The Ah receptor is nature's perfect device for testing these sorts of compounds," Allen said. "We are excited that our tests will utilize genetically engineered Ah receptor as an analytical tool, delivering dioxin analysis in a kit that can be packaged and shipped throughout the world -- something that has never been done before."

Allen says it costs about $200 to test each sample for PCBs with the currently accepted analytical method of gas chromatography/mass spectrometry (GC/MS), which can be time consuming. Hybrizyme's method costs $20 per sample and analyzes about 80 samples per day.

Validation and approval of Hybrizyme's test is scheduled for completion this month by the European Commissions Joint Research Center of the Institute for Health and Consumer Protection in Ispra, Italy. The Center validates all food testing methods used in Europe.

In the Far East, Hybrizyme is helping the Japanese government with mandatory environmental testing of smokestack emissions for dioxins. The company is collaborating with Toman Corp. and Fuji Chemical Co. of Japan for the distribution of dioxin testing kits in that country.

"We think we are set for Europe and Japan. But we never really thought we would be an international company," Allen said.

With a mere seven people on staff, Hybrizyme works very hard just in the U.S. for name recognition and acceptance. There haven't been any significant events in the U.S. to boost the company's products into the public eye.

Although Hybrizyme has the backing of the U.S. Environmental Protection Agency, Allen said that recognition and acceptance is slower here than it is abroad. "It is an educational process of those who do the testing." Analytical methods such as GC or GC/ MS, which have been around for 20 years, are still the preferred method of analysis in the U.S., but Hybrizyme hopes to change that some day.

Hybrizyme has also established a partnership with Wellesley, Mass.-based PerkinElmer Inc. (NYSE: PKI), formerly EG&G. The company is a worldwide supplier of assay kits for neonatal testing and high-throughput screening tools for drug discovery. PerkinElmer provides Hybrizyme with the rights to assay technology and clinical instrumentation, and manufacturers some of the components that are part of Hybrizyme's test kits.

So far, Hybrizyme hasn't had to rely on a lot of outside funding to see it through the last five years. In addition to corporate partners and private investors, the company has received several federal SBIR grants and a $50,000 loan from the Business and Technology Development Program of the North Carolina Biotechnology Center.

Money from product sales is starting to trickle in now, and net profits will come once Hybrizyme can complete validation activities in the U.S. and finish development work on some of its test kits.

"Until then, our fulfillment lies in knowing that we will make a difference in the quality of life for so many people," Allen said.

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Simple, Inexpensive Pcb And Dioxin Tests On The Horizon

BT Catalyst, Jan, 2000

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