By Ben Butkus
Enzo Biochem said today that its Enzo Clinical Labs division has been awarded a license to provide clinical diagnostic services in Pennsylvania, the first of several states for which Enzo has applied for licensure.
As a result of the new license, Enzo Clinical Labs, which is headquartered in Farmingdale, NY, and has New York State and College of American Pathologist accreditation, has begun marketing its menu of laboratory tests in Pennsylvania, especially in the Philadelphia area, David Goldberg, vice president of corporate development for Enzo Biochem, said this week.
However, the company is particularly excited about what the new licensure might mean for the eventual uptake of ColonSentry, a PCR-based colon cancer risk-stratification test manufactured by Canadian firm GeneNews and for which Enzo has exclusive distribution rights in New York and New Jersey.
"We are exclusive in the New York/New Jersey area, but we are free at this point to go anywhere we want," Goldberg said. "The more states we can accept specimens from … the more we can broaden our appeal for these esoteric tests."
ColonSentry uses qRT-PCR to quantify the differential expression of a panel of seven mRNA biomarkers in whole blood taken from colorectal cancer patients compared with controls. GeneNews has developed a proprietary algorithm that assigns patients a risk-stratification score based on the relative expression profile of the genes.
The goal of the test "is to get people into the system, if you will, who are non-compliant with getting colonoscopies," Goldberg told PCR Insider. "The test shows whether a person who hasn't had a colonoscopy has a higher risk than the average population, and therefore should get a colonoscopy."
ColonSentry is currently available in Canada, but not in the US. In November, Enzo and GeneNews announced an agreement giving Enzo exclusive distribution rights to the test in New York and New Jersey; and Enzo said that it planned to seek approval for the test in those states and under CLIA requirements.
Enzo is still awaiting clearance from the New York State Department of Health for ColonSentry as a laboratory-developed test. However, "once we get New York state approval on an LDT, then all the other states that we have licensure in will go along," Goldberg said. "If it's an LDT in New York, then that makes it CLIA-waived. 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."
In anticipation of New York approval, Enzo would like to build out its network of states in which it can offer clinical services in order to ensure rapid adoption of ColonSentry.
If ColonSentry becomes popular among physicians — and Enzo believes it will, based on inquiries it has received thus far — "then it's going to cross state lines, because this will be a word-of-mouth test amongst physicians. We don't want doctors in South[ern] New Jersey, where we're licensed, having their colleagues in Pennsylvania [ask] about the test and want to do it, but we don't have the ability."
Enzo also currently has pending license applications with the states of Maine, Maryland, and California. "And we'll announce as we get additional licensure, because it's a good way to get the word out to doctors that are outside of our service area," Goldberg said.
In a statement, Kevin Krenitsky, president of Enzo Clinical Labs, added that as "patient care is moving increasingly to predictive diagnostics utilizing markers and gene based programs … Enzo Clinical Labs, owing to its highly regarded New York State certification, is increasingly focused on developing into a national leader for the application of esoteric testing and the diagnosis of these specimens.
"The granting of our license by Pennsylvania is thus a significant step in our ability to solicit business and accept specimens from locations other than the metropolitan New York area, where traditionally most of our business has derived," Krenitsky added.
Besides ColonSentry, Enzo either offers or is developing what it calls "esoteric and high-value diagnostics" based on multiplex DNA sequencing, alternative pathogen amplification/detection methods, and cytogenetic tests for cancer using proprietary Enzo probe technology.