UK Lung Cancer Blood Test Licensed

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LEXINGTON, Ky. (Feb. 7, 2008) − Lung cancer research from two University of Kentucky faculty members that has garnered worldwide attention is now moving an important step closer to the marketplace.

Drs. Edward A. Hirschowitz and Li Zhong have spent the last five years working on a blood test that has been 90 percent accurate in correctly predicting non-small cell lung cancer in patients years before being detected by a CT scan.

No other test has been able to successfully detect  lung cancer. Worldwide, 10 million people are diagnosed with lung cancer each year. And in the United States, Kentucky has the highest incidence and death rate from lung cancer – 49 percent higher than the national average.

Now, Rockville, Md.-based, 20/20 GeneSystems, Inc. (20/20), a developer of innovative diagnostic products for early disease detection and personalized medicine, 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 will help 20/20 with funding for further development of the blood test as well as incentives to market it.

The test has attracted national and worldwide attention in media outlets including the Wall Street Journal and the global radio program The Voice of America.

Although the researchers have received almost $1.5 million in funding for the development of the test from various sources, they recently received an additional $175,000 National Institutes of Health grant to transform the blood test into a format that real-world clinicians could easily use. And with further studies confirming the reliability of the new format, it could become the first blood test to predict cancer since the prostate specific antigen (PSA) test was introduced in the 1970s.

Studies currently are underway to confirm the reliability of the test on larger numbers of patient samples.  If successful, 20/20 plans to introduce the test within the next 12-18 months.

“Currently, only 25 percent of non-small cell lung cancer is diagnosed at an early, curable stage.  There is a compelling need for tools that lead to the detection of lung cancer in its earliest, most treatable stages” said Jonathan Cohen, president and CEO, 20/20.   “By partnering with world leaders like OCD our goal is to help establish the first accurate blood test for lung cancer that can detect the disease years earlier than the current gold standard."

The 20/20 test identified 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 about 85% accuracy suggesting that the disease may be present 3-5 years before reaching the conventional size limits needed for diagnosis by current radiographic screening methods (0.5 mm).  In several studies, researchers used blood taken from patients several years before their tumors were picked up using CT scans.