Radient Pharmaceuticals Confirms Study for its Onko-Sure® In Vitro Diagnostic Cancer Test
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This project is designed to further validate the efficiency of Onko-Sure® relative to the Carcinoembryonic Antigen (CEA) marker in colorectal cancer patients. Specifically, RPC's study compares the effectiveness of RPC's Onko-Sure® IVD cancer test to the CEA marker in a large population of patients (N=976), including non-cancer patients (normal) and patients in stages I through IV (Dukes A through D) with colorectal cancer.
A single study using serum samples from a large population of colorectal patients has never been conducted, and it is anticipated this study will further clarify the efficacy of Onko-Sure® compared to CEA, and/or, in comparison to potentially combining these two markers.
The study has market significance because of the large number of early stage colorectal cancer patients globally that can potentially benefit from a diagnostic test offering an effective tumor marker for early detection of a recurrence of colorectal cancer.
As part of a collaboration agreement with Mayo Validation Support Services (MVSS), MVSS provided RPC with 976 biospecimens and annotation that were tested by Mayo with the standard CEA cancer screening test.
Radient completed the testing of the biospecimens using its Onko-Sure® IVD cancer screening test on March 4, 2011 and will submit the data from its Onko-Sure® tests, along with the CEA tests performed on the same samples by MVSS, to a third party statistical analysis service for sample decoding. The final study results will be part of RPC's clinical post-launch validation of Onko-Sure®. Under the agreement, the final RPC study data and corresponding results will be returned to MVSS.
The FDA-cleared Onko-Sure® in July 2008 and it has been independently validated by six different peer-reviewed studies with results published in various scientific journals. In 2010 alone, there have been two post-launch validation studies published on Onko-Sure®. The following is the link to the FDA website for RPC's Onko-Sure® clearance.