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Securing the license is important, said Orion President and Chief Executive Nathan Lakey. But other hurdles remain before the company’s test can reach the market and begin affecting people's lives.

First, Orion and its research collaborators must conclude a large prospective trial to determine whether the particular genetic change they are tracking does, indeed, indicate a patient is more likely to develop an early case of colon cancer. That trial is under way, and Lakey said the results could come as soon as the first quarter of next year.

If the data is favorable, it would feed into Orion’s application for marketing approval from the Food and Drug Administration. That process could take months.

And then Orion will need to raise venture capital, and maybe take on a corporate partner to fund sales and marketing.

There’s a tremendous unmet need” for this type of screening, Lakey said. If the test pans out, “the potential for saving lives is strong.”

That’s because colon cancer, also called colorectal cancer, is the third-most commonly diagnosed cancer among men and women in the United States, according to the National Cancer Institute. It is the second-most-deadly type of cancer, in part because the disease has spread to other parts of the body by the time it is discovered in about 60 percent of cases.

This year, the disease will be diagnosed in 148,810 Americans and kill 49,960, the NCI estimates.

Orion is targeting colon cancer because, if it is caught early enough, there are good treatment options for halting its progression, Lakey said. Once patients know that they have the disease, they can act to stop it.

Lakey described the company’s approach:

Orion and the Johns Hopkins team have identified a genetic change, or biomarker, that can be measured in the blood of colon cancer patients. But they are caught in a chicken-and-egg question - did the tumor cause the biomarker to be present, or did the biomarker come first? If the prospective study proves the biomarker was present first, then it could be a useful predictor of whether a person is likely to develop the disease.

If that is the case, Orion would recommend its test be given to people once while they are in their 20s or 30s. A patient who carries the biomarker could immediately begin routine screening tests, such as a colonoscopy, to catch the disease in an early stage.

Today, such screening begins at age 40 for people with a family history of colon cancer; and at 50 for the rest.

Lakey said the Orion test could have an additional benefit: Patients who are negative for the biomarker may be able to put off physical screening tests until they are older than currently recommended, saving health care dollars and delaying the unpleasant procedure.

If the test works, it could serve “as a tool to help physicians in developing targeted monitoring plans and shifting resources to the people most likely to develop colon cancer,” said Dr. Graham Colditz, associate director of prevention and control at the Alvin J. Siteman Cancer Center. He also is a scientific adviser to Orion.

Dr. Len Lichtenfeld, deputy chief medical officer of the American Cancer Society, said genetic research in cancer is “incredibly exciting” and undoubtedly will pay off. The day will come when biomarkers will be clinically useful in helping doctors to parse patients into different risk groups.

But he cautioned that, in general, the science is early and will take years to prove. He is not familiar with the specific work of Orion and its collaborators.

“This is part of a larger picture - we’ve learned so much now about what makes a cancer cell cancerous, and we continue to learn more almost daily,” he said. “There’s a lot of hope that comes out of labs” but in most cases, it will take time until that work is useful in treating patients.

Lakey said he is optimistic that his firm's test will soon be helping to save lives.

“The future's bright, and we’re pretty excited about the opportunities,“ he said.