Radient Pharmaceuticals Corp announced it has resumed collaborations with Mayo Collaborative Services to conduct a clinical study for the validation of RPC’s US FDA-approved Onko-Sure® in vitro diagnostic (IVD) cancer test as a useful tool in colorectal cancer (CRC) recurrence and treatment monitoring.
Over 1,000 colorectal patient samples with various disease stages will be tested in parallel by RPC and Mayo Clinic to directly compare the results of the Onko-Sure® test with the Carcinoembryonic Antigen (CEA) test.
The primary goal of the study is to determine whether Onko-Sure® is more effective than CEA at detecting early stage colorectal cancers. CEA has been reported to misdiagnose a disproportionate number of early stage cancers. Detecting cancer in earlier stages can lead to improved accuracy in the treatment, monitoring and recurrence monitoring of the disease in cancer patients. This head-to-head study is scheduled to be completed in the fourth quarter FY2010 and data generated will be provided to Mayo physicians and investigators for publication in medical journals.
"We are very excited to resume collaboration with Mayo’s Validation Support Services team.
This marks a critical and potentially market changing milestone for Radient Pharmaceuticals and for our Onko-Sure® IVD cancer test," commented Douglas MacLellan, Chairman and CEO of RPC. "Through this work, we expect to validate the efficacy of RPC’s Onko-Sure® test as a critical tool for treatment, monitoring, and/or recurrence monitoring of colorectal cancer suffers."
Source: Radient Pharmaceuticals Corp
