Micronics to Roll Out Pocket-Sized Malaria, E. coli Tests This Year

Micronics has been around since 1996, so it hardly qualifies as a startup anymore. But the Redmond, WA-based biotech company has been moving in new directions over the last few years, and is now getting ready to bring its first diagnostic tests to the market.

The 28-person company has been in the microfluidics business—the design of tools to manipulate very small amounts of liquid (sometimes called “lab on a chip”)—since its inception 13 years ago, when it spun out of research from the University of Washington. More recently, says president and CEO Karen Hedine, the company has shifted into using its knowledge and inventions in microfluidics to create novel diagnostic tools.

Micronics has raised a total of about $25 million in funding, Hedine said, including $9 million in 2008 through private Series B investors and a Series C financing round led by the Southwest Michigan First Life Science Fund.

The company has decided to focus on infectious diseases, Hedine said. Micronics’ first diagnostic product, which it hopes to debut by the end of 2009, will be a small, disposable test for malaria. “We look at targets that are unmet needs,” Hedine said. “A malaria diagnostic is one of the most unmet needs out there.”

Right now, Hedine said, even in a best case scenario like a Western world clinic, diagnosing the disease usually requires several clinic appointments and at least a few weeks to get an answer back from the lab. Micronics hopes to turn those weeks into minutes, and reduce the amount of blood or urine required from a large vial to a few drops.

The malaria tests are aimed for use in developing countries, where the disease is most prevalent. Hedine said she expects Micronics’ customers might include clinics in these areas, as well as charity organizations, governments donating aid, non-governmental organizations, or militaries stationed in countries where malaria is common.

So far, Micronics’ money has come from three avenues, Hedine said: investment financing, revenue from lab equipment and consulting services, and grants or contracts for the development of some of its diagnostic tools. The tools are built on small, disposable plastic cards, and use minute amounts of fluids—for both the sample required from the patient and the chemical reagents needed to process it, Hedine said. They’re designed to run on a “finger-stick” worth of blood, similar to home blood-sugar monitors for diabetics.

After the malaria tests, Micronics plans to release a similar test system for E. coli, which has been a recent culprit in widespread food poisoning scares in the United States, as well as a portable, rapid blood-typing test whose development was funded by the U.S. Army. The company is also working with the Centers for Disease Control and Prevention to develop similar tests for HIV. Hedine said diagnostic tests for a panel of other STDs are further down the pipeline.

The malaria and E. coli tests will be ready for regulatory testing by the middle of the year, Hedine said, and she hopes they will be approved in time to be released before 2010. “We’re really revolutionizing the way testing is done,” Hedine said.