Agilent Registers Cedar Creek Facility with FDA to Manufacture Diagnostic Products
News Jun 30, 2011
Agilent Technologies Inc. has announced that its Cedar Creek, Texas, reagent manufacturing facility has been registered with the U.S. Food and Drug Administration as a medical device establishment.
This registration is required for the manufacture of diagnostic products, which Agilent intends to develop.
“Many of Agilent’s proven research platforms hold potential in diagnostic markets,” said Robert Schueren, Agilent vice president, Genomics.
Schueren continued, “We’ve made a commitment to bring improved diagnostic tools to the medical community. Having an FDA-registered manufacturing facility is yet another step in this endeavor.”
Agilent currently manufactures and packages a wide range of research bioreagents at the 80,000-square-foot Cedar Creek facility, including enzyme-based reagents and high-fidelity oligonucleotides.
The company has built separate, dedicated diagnostics space with additional room for expansion as needed.
In a small study of patients referred to the Johns Hopkins Early Psychosis Intervention Clinic (EPIC), researchers report that about half the people referred to the clinic with a schizophrenia diagnosis didn’t actually have schizophrenia. People who reported hearing voices or having anxiety were the ones more likely to be misdiagnosed.