Imagine having the tools necessary to see potential drug side effects before they occur, or to diagnose disease at the very early stages before symptoms are experienced.

It could change the whole drug development landscape.

Companies could design drugs with more precision, and with early diagnosis through a tiny blood sample, those drugs could change the path of disease. Some of the sharpest minds in biotech anticipate that this very field could greatly influence tomorrow's health care.

It's an area of research in which privately held Predicant Biosciences Inc., of South San Francisco, might have a huge impact if its diagnostic technology reaches the market on schedule in the first half of 2006. The company is using microfluidics for its proteomic tests designed to identify complex protein patterns in blood in order to diagnose and monitor disease. With microfluidics, fluids move through a network of channels, each of which is narrower than a human hair.

Predicant signed an agreement this week concerning the microfluidics patent estate of Hopkinton, Mass.-based Caliper Life Sciences Inc. Caliper has been working near the front of the field with the hope that its technologies will help biotech and pharmaceutical companies develop more effective diagnostics and therapies.

"What we've been focused on is the opportunity to get results with much smaller sample sizes," said Kevin Hrusovsky, CEO and president of Caliper. "Some of the technologies we're developing have a significant amount of precision and accuracy that could enable the observation of mutant genes at a much higher sensitivity. If you can identify mutant genes, you have the potential to see things sooner."

Through the agreement, Predicant gains nonexclusive rights to a major portion of Caliper's microfluidics patent estate with plans to use the technology to analyze proteins using mass spectrometry. The agreement covers the full set of Caliper's intellectual property assets relevant to Predicant's product-development efforts. It does not include Caliper's reagent IP and certain microfluidic patents not related to Predicant's programs.

While financial terms were not disclosed, Caliper's agreements typically include an up-front payment and a royalty if a product is developed and marketed.

Shawn Becker, Predicant's vice president of marketing, said the potential for its technology is large and might be applied to many different kinds of diseases.

"We think the whole field of molecular diagnostics is about to take off," Becker told BioWorld Today. "The goal of our company is to provide clinicians with key clinical information that they wouldn't otherwise be able to get."

Predicant's technology involves the collection of a blood sample that is run through microfluidics in order to identify key proteins, which are introduced to the company's mass spectrometer.

Samples are processed faster with microfluidics, and they are more reproducible than samples processed with traditional separation techniques, Predicant said.

Caliper's technologies can be applied to drug discovery, as well as diagnostics. The goal is to develop tools with extra sensitivity to find the same results in smaller quantity samples, Hrusovsky said.

"We've done this in the drug discovery markets where there's a lot of concern today about drugs having side effects, such as Vioxx, Aleve and even Celebrex," he said.

The company's LabChip 3000 enables researchers to see when a compound might have inhibition activity on a kinase. Caliper launched the product in mid-2004 and already has installed the product at Pfizer Inc., of New York; Merck & Co. Inc., of Whitehouse Station, N.J.; Aventis, a unit of Paris-based Sanofi-Aventis Group; Johnson & Johnson, of New Brunswick, N.J.; and Amgen Inc., of Thousand Oaks, Calif.

Microfluidics allows the test volume to be so small that the data become a much higher quality or resolution, Hrusovsky said.

"That leads to better decisions, and you can discover drugs more efficiently," he said. "There's a lot of bad data that gets created today and that causes companies to have to run a lot of extra trials to eliminate bad data from good data."

Caliper's technology also allows researchers to analyze and measure the activity of a primary cell as opposed to engineered cell lines, meaning there's a greater chance that scientists will spot human side effects earlier in development.

By pairing up drug research with diagnostic efforts from companies like Predicant, the industry has a young new field of personalized medicine.

"If you identify a cancer before it actually becomes cancer, you may have a very different regimen of how you go at that," Hrusovsky said.

While such methods could lead to finding markers of disease several years before the sickness occurs, possibly preventing it altogether, companies are taking it one step at a time. For now, Predicant mainly is focused on finding disease at the early stages in order to intervene with optimal treatments.

"This whole field of personalized medicine is very nascent," Becker said. "But it's going to take technology such as Predicant's to make that dream a reality."

Founded in 2002, Predicant raised $27 million in a Series A round in 2003 and changed its name from Biospect Inc. early last year. (See BioWorld Today, Oct. 22, 2003.)

Caliper's stock (NASDAQ:CALP) rose 23 cents on Thursday, to close at $7.68.