By Kirell Lakhman
GeneNews is expected to debut in its ColonSentry colorectal cancer screening LDT in New York State either by the end of the year or within the first three months of 2011, according to an equities analyst.
Reni Benjamin of Rodman & Renshaw on Tuesday said GeneNews's R&D partner Enzo Biochem's clinical lab division has finished validating the PCR-based test, and is about to submit the final data package to state regulators.
The prediction comes one week after GeneNews granted Enzo a license to do business in Pennsylvania, which is part of GeneNews' broader goal to become a national provider of molecular diagnostics.
In a report to investors yesterday, Benjamin said that the validation process showed “consistency" between the risk stratification scores obtained by both companies across a panel of 50 patients.
With that out of the way, he said, Enzo will submit the data to state regulators sometime before the end of September, and "anticipates" regulators to take between three and six months to review and respond.
He said the test has the "potential [for] approval by year end or in the first quarter of 2011."
ColonSentry uses art-PCR to quantify the differential expression of a panel of seven mRNA biomarkers in whole blood taken from colorectal cancer patients and compared with controls. GeneNews has also developed an algorithm that assigns a risk-stratification score based on the relative expression profile of the genes.
The companies' partnership began last November when GeneNews granted Enzo Clinical Labs exclusive rights to market ColonSentry in New York and New Jersey.
Last week, GeneNews announced steps to expand its reach by eventually offering the assay in Pennsylvania. The three-state play is part of GeneNews' goal of selling its molecular diagnostics nationwide.
Enzo Clinical Labs, based in Farmingdale, NY, has CAP and New York State accreditation. GeneNews is headquartered in Toronto. ColonSentry is currently sold only in Canada.
Besides New York, New Jersey, and Pennsylvania, Enzo has pending license applications in Maine, Maryland, and California.
Last week my colleague Ben Butkus spoke with David Goldberg, vice president of corporate development for Enzo Biochem, who said the company is "exclusive in the New York/New Jersey area, but we are free at this point to go anywhere we want. The more states we can accept specimens from … the more we can broaden our appeal" for the tests.
"Once we get New York state approval on an LDT, then all the other states that we have licensure in will go along. If it's an LDT in New York, then that makes it CLIA-waived," Goldberg added. "And at that point we don't have to go back to the other states that we have licensure in and get an LDT approval there."