Radient Pharma: New Onko-Sure Test Results

TUSTIN, Calif. (TheStreet) --Radient Pharmaceuticals(RPC) said Wednesday that its Onko-Sure cancer-monitoring test performed better than an older, competing test in detecting early-stage colon cancer, but the company didn't disclose how the performance of the two tests compared across all stages of colon cancer.

The new but limited disclosure about Onko-Sure's performance comes from what Radient described as the "final data set analysis" of a U.S. clinical validation study. This study was designed to compare the efficacy of Onko-Sure against the carcinoembryonic antigen (CEA) test. Both Onko-Sure and CEA are approved in the U.S. as lab tests that doctors can use to monitor the progression of colon cancer in previously diagnosed patients.

Radient's Onko-Sure test "can be up to 17% more effective" at detecting colon cancer in stages I and II compared to the CEA test, the company said Wednesday. Radient did not say whether this 17% advantage was statistically significant, nor were important and relevant details provided such as the comparable sensitivity and specificity of the Onko-Sure and CEA tests, respectively.

When Radient released interim results from this same study on March 31, the company said Onko-Sure demonstrated a "significant advantage" over the CEA test in detecting early-stage colon cancer.

The Onko-Sure study was designed to test blood samples taken from 976 patients with all stages of colon cancer. Radient has not disclosed how Onko-Sure performed relative to the CEA test when all the colon cancer patient blood samples were analyzed. Radient did not give an explanation Wednesday for releasing partial results from the study's final analysis.

The combined use of Onko-Sure and CEA was more sensitive at detecting colon cancer progression than the use of either test by itself, Radient said Wednesday in a repeat of a claim made when the company announced preliminary results on March 31.

This Onko-Sure clinical validation study is the same one that Radient previously claimed was being conducted with the prestigious Mayo Clinic research hospital. As first reported by TheStreet in March, the Mayo Clinic said it did not work with Radient on the Onko-Sure clinical trial, explaining that it only sold blood samples to Radient for use in the Onko-Sure study.