Lung Cancer Blood Test Licensed

by Amy Ratliff, UK Public Relations
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Lung cancer research by two University of Kentucky faculty members, featured in The Wall Street Journal and on the global radio program The Voice of America, is now moving an important step closer to the marketplace. Markey Cancer Center researchers Edward Hirschowitz and Li Zhong have spent the last five years working on a blood test that has been 85 percent accurate in predicting non-small cell lung cancer (NSCLC) years before the cancer could be detected by a CT scan.

Approximately 213,000 people are diagnosed with lung cancer each year, and 85 percent of those will die within the first five years of diagnosis. Kentucky has the highest incidence of and death rate from lung cancer—49 percent higher than the national average.

The Maryland-based company 20/20 GeneSystems Inc., which develops diagnostic products for early disease detection, has entered into an agreement with Ortho-Clinical Diagnostics (OCD), a Johnson & Johnson company, to license—and ultimately market—the Hirschowitz and Zhong blood test. The agreement provides 20/20 with funding for further development of the blood test as well as incentives to market it.

The researchers have been awarded almost $1.5 million in funding for the development of the test from various sources, and they recently received an additional four years of funding from the National Institutes of Health. Hirschowitz says moving this test from the laboratory to the clinic involves assuring the reliability and applicability to the general population (with more patients, different demographics).

Studies currently are under way to confirm the reliability of the test on a larger group of blood samples. If successful, 20/20 plans to introduce the test within the next year. It would become the first blood test to predict cancer since the prostate specific antigen test was introduced in the 1970s.

“Only 25 percent of non-small cell lung cancer is diagnosed at an early, curable stage,” says Jonathan Cohen, president and CEO of 20/20. “By partnering with world leaders like OCD we hope to help establish the first accurate blood test for lung cancer that can detect the disease years earlier than the current gold standard.”

The test identifies panels of antibodies generated by the body’s immune system in response to very early stage NSCLC. Studies have shown that the presence and amounts of these antibodies in the blood predicted NSCLC with 85 percent accuracy, suggesting that the disease may be present three to five years before reaching the necessary size needed for diagnosis by a CT scan.