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SACRAMENTO, Calif. -- Researchers at UC Davis Medical Center hope to bring to market one day a test that will expose ovarian cancer -- long known as "the silent killer" -- while it's still in its early, treatable stages.
The road to profitability for a new diagnostic test is long and fraught with uncertainties.
Yet Carlito Lebrilla is willing to take the risk. The chemist and his research partners are stalking cancer cells, studying their tendency to produce and slough off strange carbohydrate molecules.
These compounds can then be detected -- at extremely low concentrations -- in a patient's blood. Even the stealthiest of killers leaves clues.
"People have known for a long time that the carbohydrates change" in a patient with cancer, said Lebrilla. "What has been difficult is developing methods to analyze them."
Lebrilla stressed that the new detection method is in its infancy. While it has shown enough promise to prompt the University of California to patent it, it must be validated by further research.
And, before the researchers can turn their discovery into a business, they must attract investors. That won't be easy in an environment where even the most innovative tests don't always net a juicy payoff.
"Investors in general are much more inclined to invest in therapeutics" -- such as new medications -- than in diagnostic tests, said Peter Matlock, a Davis consultant who advises life science companies.
Revenues for companies in the diagnostic test business are largely determined by Medicare reimbursement rates, Matlock explained. It's a struggle to get Medicare, and the many private insurers that use the federal program as a benchmark, to raise payout levels to a level that can make a costly new test profitable for the company that developed it.
The researchers have founded a West Sacramento-based company, Glycometrix Inc., and are in discussions with venture capitalists.
Glycometrix adds to the list of Sacramento-area companies trying to capitalize on one of the region's key biotechnology resources: a collection of chemists who are experts at analyzing tiny concentrations of naturally occurring molecules. It's one outgrowth of decades of UC Davis research on the delicate chemistry of plants, people and, for that matter, wine.
Glycometrix's test, if successful, would benefit thousands: More than 16,000 women died in the United States last year from ovarian cancer, a disease that so far has no reliable early detection test.
Doctors use a decades-old blood test to check for ovarian cancer, but it is useful only for monitoring patients who have been treated for the disease, said Gary Leiserowitz, a member of the research team and the chairman of the Division of Gynecologic Oncology at University of California, Davis, Medical Center. As an early detection tool, he added, it's terrible because it gives a positive result for many women who don't have ovarian cancer.
A make-or-break period for the new test is coming up, as researchers see if its early promise stands up to further testing.
The researchers are optimistic that their test will succeed where others have failed because it approaches the cancer detection problem from a new angle. While competitors have focused on detecting small changes in the very complex protein molecules that cancer cells produce, the Davis group is looking at changes in certain carbohydrates, which are much simpler.
Ordinary human blood is full of many different carbohydrates, but certain types appear only when cancer is growing somewhere in the body. However, the concentration of those telltale molecules generally is so low and the chemical aberrations so subtle that, until recently, it was not been practical to look for them as harbingers of disease.
The group is publishing in the Journal of Proteome Research today the results of a preliminary study that analyzed blood taken from 10 research subjects.
At this point, the researchers don't know if the test can distinguish between carbohydrates produced by ovarian cancer cells and those generated by other types of cancer cells. They plan experiments to answer that question.
About 22,000 women in the United States are diagnosed with ovarian cancer annually, according to the American Cancer Society.
For women, it is the fourth most deadly type of cancer -- behind lung, breast and colon cancer.
Once ovarian cancer spreads beyond the ovaries, only 28 percent of patients survive. But when doctors detect the disease before it spreads, the survival rate jumps to 95 percent.
About half of women who have early stage ovarian cancer do show some symptoms, like bloating or vague abdominal pain, Leiserowitz said. Unfortunately, since those symptoms could have many other causes, patients seldom end up getting a pelvic exam, which might reveal signs of cancer.
Even if a pelvic exam does spot an abnormality, the course of treatment isn't immediately clear, he said.
Because the process of taking a tissue sample from an ovary presents a high risk of spreading the cancer if it is present, the entire ovary must be removed and sent to a pathologist for analysis.
"You end up having to do a major surgical procedure to determine what's going on," he said. "All you need is a better test."
c.2006 The Sacramento Bee
