WisBusiness: EraGen Biosciences builds its internal capacity as steps to growth

By Brian Sweeney

MADISON – EraGen Biosciences, a medical diagnostics company that made a name for itself with its quick response to a need for tests for severe acute respiratory syndrome (SARS) in 2003, has taken that buzz and turned itself into a growing fixture in the industry.

By the end of last year, the company had developed three major products that are on the market and are providing EraGen with a growing share of the diagnostic market.

“We have a whooping cough test, a test for HSV (Herpes Simplex Virus 1 and 2) as well as a respiratory viral panel. Those were the three big products from the end of last year. Those are starting to take off, along with some custom products,” said Dr. Irene Hrusovsky, EraGen’s chief executive officer.

These tests involve EraGen’s patented MultiCode technology, which relies on an expanded genetic alphabet to provide accurate and fast results. But Hrusovsky says last year’s greatest triumphs may not be the products themselves, but the advancements made in the company, its organization and the rigors of regulation.

“One of the key accomplishments from last year was, first of all, attracting three senior executives to lead quality and regulatory, manufacturing and product development efforts. And, at the end of the year, achieving ISO 13485 certification,” she said. “That basically sets you up so you can actually market products into Europe as well as Canada.”

Qualifying for ISO 13485 certification requires full implementation of a quality management system and also affords a company the huge benefits of becoming Food and Drug Administration (FDA) compliant. So, in one step, EraGen gained domestic qualification and the ability to expand internationally, not to mention the internal benefits of the quality management system itself.

“That’s one of the operational milestones you need to achieve as a company. It’s a huge hurdle, especially for a small company because it entails a lot of operational infrastructure. The whole management system needs to be in place, operational. That was the best news of last year – it was really a major milestone,” Hrusovsky said.

The company deals with clinical laboratories almost exclusively, and has collaboration partnerships with a number of institutions such as UW-Madison and some other research institutions. These institutions rely on EraGen’s products as key parts of their research.

“In the case of UW, we’ve been working with Dr. James Gern and his team for the last three years, developing our respiratory panel test together,” Hrusovsky said.

All this came about in tandem with a successful funding campaign, which raised $11.9 million for the company in 2005. That money was used to ramp up product development, which was successful in the release of new products.

The money also helped to get the quality management system fully operational, which EraGen did with ISO 13485 certification and recognition by the FDA. That money helped get EraGen’s products in order and ready to sell, but that is only half the battle.

“We’re going to launch into raising equity for expanding commercialization of our products,” Hrusovsky said. “That involves accelerating product development, accelerating regulatory approvals and expanding the customer base.”

EraGen is looking to expand in a big way, and marketing is the company’s next logical step. But, as the company hits the marketing highway, it won’t stop developing new and innovative products.

“The next wave is to focus on commercialization,” Hrusovsky said. “But now that we’ve got the infrastructure, we also need to get more products registered for FDA approval and be selling more products to more customers.”

Sweeney is a student in the UW-Madison Department of Life Sciences Communication.