MUKILTEO, Wash.—For many in the pharmaceutical and medical industries, personalized medicine has become the latest holy grail, and CombiMatrix Corp. believes it has the right DNA microarray capabilities to be a leader in making personalized medicine a reality. As such, the company recently formed a wholly owned subsidiary called CombiMatrix Molecular Diagnostics (CMD), which will be led by two former executives of Irvine, Calif.-based US Labs.

 

At the heart of personalized medicine is the notion of looking at diseases and treatments on a molecular and genomic level so that diagnostic and therapeutic options can be targeted to specific patients and populations. This, of course, requires significant insight into genetics, something which Dr. Amit Kumar, president and chief executive officer of CombiMatrix, says CMD will provide in abundance.

 

"CombiMatrix believes DNA microarrays are the future of diagnostics and personalized medicine," Kumar says. "CombiMatrix has a unique approach to this opportunity, and we are moving now to capitalize on it through the formation of CMD."

 

To lead CMD, CombiMatrix tapped Matthew C. Watson, former vice president of laboratory operations for US Labs, to be CMD's CEO, and Dr. David A. Baunoch, former vice president of research and development for US Labs, to be president and COO.

 

"Not only are they highly talented from an experience standpoint, but they are highly entrepreneurial," Kumar says. "They are well-connected in the industry and have great credibility in the investor community, and they are already looking for strategic partnerships. If you are going to do any kind of startup in this industry, these are the two guys you want to have on board to do it."

 

Since 1999 or 2000, personalized medicine and how molecular diagnostics could make it a reality have been a hot topic in the industry, Kumar recalls, but the idea was too early, and the technology still too young, to move theory into reality. Not so anymore, according to CombiMatrix and CMD.

 

"Molecular diagnostics is about to revolutionize the way illnesses are diagnosed and treated, and CMD will be at the forefront of this paradigm shift," Watson says.

However, despite recent technological improvements, hurdles remain. One of the biggest, as Kumar sees it, is approval of laboratory testing technologies by the U.S. Food and Drug Administra-tion (FDA). The process can take years and millions of dollars, he says, and that can hold up laboratories and others from being able to access testing that will allow personalized medicine to take root soon.

 

That's where CombiMatrix and its new CMD subsidiary come into the picture.

"The FDA doesn't have to approve lab-developed tests, also known as 'home-brew' tests. Flow cytometry, PCR and pretty much all molecular diagnostics fall into that category and thus can be used—and get reimbursement—even though they aren't FDA-approved," Kumar explains. "Labs heard that we could prove chip synthesizers so that they could start making microarray chips themselves, and thus have those chips considered home brew."