A group of Boulder researchers at MiRagen Therapeutics Inc. do research that could lead to just such a test. They have found that heightened levels of the molecule they have named MIR-208 in the blood can lead to heart damage and heart failure, said Bill Marshall, chief executive officer and a founder of the company.
The researchers came up with test information as they worked on creating a new heart disease treatment drug. They set up studies to monitor microRNA variations in blood, based on the drug treatment, Marshall said. Other research from around the United States shows that changes in microRNAs in the blood can be correlated with the severity of a variety of diseases, he said.
“This piqued our interest,” Marshall said. “We have been able to find several (microRNAs) that are altered in the bloodstream … that appeared to be indicative of further worsening of the disease.”
Since coronary heart disease is the leading cause of death in the United States, the research could lead to big sales after it goes through an approval process with the Food and Drug Administration. A biomarker is any biological measurement that can be used to indicate something about your body. It can be simple, such as your height, or complex, such as the molecule in question found in your blood.
MiRagen plans to focus on drug treatment rather than microRNA tests, however, Marshall said. In the future, MiRagen may partner with Boulder bioscience company SomaLogic Inc. or another diagnostic company in the region to develop the test, he said.
“It’s a win-win scenario, since a lot of the research we do guides us in how the drug is working,” Marshall said. “It’s advantageous in identifying markers so that we can target therapeutic agents. The early work is to identify the important biomarkers.”
MiRagen is one of several local companies that are considered leaders in the global biomarker research field. SomaLogic, which researches proteins, is considered a forerunner in the field. Boulder diagnostic company Biodesix Inc. is another player, as is TeraBAT Inc. in Longmont.
“The field is just booming, as people are using these new tools to try to understand how to improve medicine,” said David Brunel, a founder of Biodesix. “I think it’s one of the big growth areas in biotechnology in the next decade.”
As the cost of health care continues to rise, the diagnostic market gets ever more important, Brunel said. He estimated the worldwide market for diagnostic products at $5 billion. A clinician may take weeks or months to diagnose a disease for, example, but new blood tests may be able to give results in days, according to Brunel. Biodesix researchers are developing the VeriStrat diagnostic lung cancer test.
While the biomarker field is getting attention from others in the health-care industry these days, SomaLogic Inc. has been researching protein biomarkers in the blood for the past 23 years, said company founder Larry Gold. SomaLogic now partners with national pharmaceutical players such as Novartis International AG (NYSE: NVS in the United States) and Quest Diagnostics Inc. (NYSE: DGX) to develop its products.
Now that the company is close to having marketable products, “it’s an exciting time,” Gold said.
“We are fortunate to have done something that no one else has been able to do — to measure precisely and quantitatively, proteins in a way that nobody else can do,” Gold said. “I think everyone believes we’re on the leading edge of it, and it’s so much fun to be there.”
The field also includes biomarkers found in exhaled breath, said Eyal Gerecht, a founder of TeraBAT Inc. in Longmont, which does research on the heart disease biomarkers found in exhaled breath. TeraBAT is competing with companies across the nation to come up with technology that patients can breathe into in every emergency room and every drugstore in the future, Gerecht said.
Jack Wheeler, TeraBAT’s chief business officer, points to Gold as the impetus for the region’s reputation as a biomarker research hub. So does Brunel, who worked with Gold to license the rights to the original University of Colorado-Boulder research to start SomaLogic.
“SomaLogic now is probably leading the industry,” Brunel said. “It’s one thing to be able to measure something. To do it reliably and produce it day in and day out takes a lot of work.”
MicroRNAs and proteins aren’t the only potential biomarkers being researched in the human body, however, Marshall said. Local and national researchers also look at the changes in peptides and metabolites to try to come up with new products, he said.
“At the end of the day, our goal is to create human therapeutics that change the course of these difficult-to-treat diseases,” Marshall said. “It’s treating the right patient at the right time with the right medicine.”