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20/20 Licenses Lung Cancer Blood Test to Ortho-Clinical Diagnostics

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20/20 GeneSystems, Inc. has announced that it has entered into an agreement with Raritan, N.J., based Ortho-Clinical Diagnostics (“OCD”) to license certain 20/20 intellectual property relating to a blood test for the early detection of lung cancer.

The agreement provides 20/20 with up-front fees, development funding, milestone payments, and royalties on product sales by OCD. This agreement also follows a funding award jointly from the Johnson & Johnson Corporate Office of Science and Technology (COSAT) and the Maryland Technology Development Corporation (TEDCO) relating to this blood test.

20/20 and its collaborators from the University of Kentucky have published study results that showed that its multi-biomarker blood test may be able to detect non-small cell lung cancer (NSCLC) significantly earlier and with better accuracy than CT scans, the most advanced technique in current use for detecting this disease, the company says.

Study findings were published in 2006 in the Journal of Thoracic Oncology. Studies are underway to confirm the reliability of the test can be confirmed on larger numbers of patient samples. 20/20 hopes to introduce the test within the next 12 to 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 blood 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 predicts NSCLC at an accuracy rate greater than that of any other known test. This suggests that the disease may be present three to five years before reaching the conventional size limits needed for diagnosis by current radiographic screening methods (0.5 mm).

In several studies, the University of Kentucky group detected cancer in blood samples taken from patients several years before their tumors were picked up using CT scans. In this co-exclusive arrangement, 20/20 retains the right to enter into licenses and business relationships with a limited number of third parties as well as to develop and market its own lung cancer detection test.