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FDA Clears Iris' Prognostic Test for Prostate Cancer

NEW YORK (GenomeWeb News) – Iris International today announced that the US Food and Drug Administration has granted 510(k) clearance for its Nadia ProsVue prognostic cancer test for prostate cancer.

The assay, which combines immunoassay with real-time PCR methodologies, is for determining the rate of change of total prostate-specific antigen in serum over time and is not intended for the diagnosis or monitoring of prostate cancer, Iris said. The test is for use with clinical evaluation to identify patients at reduced risk for recurrence of prostate cancer for eight years after prostatectomy.

In a retrospective clinical study of 304 patients, Nadia ProsVue achieved a negative predictive value of 92.7 percent and a positive predictive value of 78 percent.

"We believe this prognostic assay could help patients avoid unnecessary treatment, reduce morbidity, and lower the cost of management and treatment of post-radical prostatectomy patients," Cesar Garcia, president, chairman, and CEO of Iris, said in a statement.

Iris will initially make the test available through its CLIA laboratory. The company also plans to collaborate with laboratories and diagnostic partners to offer the test, it said.

Citing statistics from the American Cancer Society, the company said that 217,730 new cases of prostate cancer were diagnosed in 2010 in the US with 32,050 deaths, making it the second-leading cause of cancer deaths in men.

FDA clearance "gives us confidence in the capability of our … technology to identify extremely low concentrations of proteins that have not been routinely used as a diagnostic or prognostic aid, in the absence of assays with the sensitivity and precision of Nadia," Thomas Adams, CTO and head of Iris Molecular Diagnostics, said. "We plan to accelerate our efforts to license the Nadia technology and to develop other assays with significant market opportunities in the field of oncology."

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