GeneNews partner readying ColonSentry submission

Enzo Biochem’s (NYSE:ENZ) clinical labs division has completed validation testing of the GeneNews (TSX:GEN) ColonSentry pre-screening test for colorectal cancer and is in the final stages of submitting the data package to New York State regulatory authorities, according to a new report by Rodman & Renshaw.

Analyst Reni Benjamin writes that the validation “demonstrated consistency between the risk stratification scores obtained by Enzo and those obtained by GeneNews, across a panel of 50 patients.”

He figures Enzo will submit the data package to regulators in the current quarter. “We anticipate a three-to six-month review period, with a potential approval by yearend or in the first quarter of 2011,” he said.

Last November, GeneNews licensed ColonSentry to Enzo Clinical Labs, with exclusive rights to market the test in New York and New Jersey.

Last week, in Pennsylvania awarded a license to Enzo’s clinical labs division to do business in the state as part of a company plan to become a national provider of molecular diagnostics tests.