NEW YORK (GenomeWeb News) – Enzo Biochem today announced that its clinical lab has been approved by Pennsylvania.
The Enzo Clinical Labs is CLIA approved and CAP accredited but in order to operate in Pennsylvania needs separation approval from regulators in that state.
The company also has pending license application in Maine, Maryland, and California.
The license from Pennsylvania is a "significant step in our ability to solicit business and accept specimens from locations" other than the metropolitan New York City area," Kevin Krenitsky, president of Enzo's Clinical Labs division, said in a statement. The lab is also approved by New York state.
"Patient care ins moving increasingly to predictive diagnostics utilizing markers and gene-based programs, and 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," Krenitsky said.
The company is developing its ColonSentry colon cancer risk-stratification assay, multiplex DNA sequencing, alternative amplification/detection methods for pathogens, and other diagnostic tests.