NEW YORK — Siemens Healthineers said on Wednesday that it is now distributing Ark Diagnostics' fentanyl assay to laboratories.
The ARK Fentanyl Assay — which was cleared by the US Food and Drug Administration in 2018 and is CE marked — detects both fentanyl and norfentanyl, a metabolized form of fentanyl, "enabling laboratories to identify more true positives."
Siemens noted that about 90 percent of a dose of fentanyl is excreted in urine as norfentanyl, while parent fentanyl accounts for less than 7 percent. Because fentanyl metabolizes rapidly, assays that measure only fentanyl typically have a shorter window of detection. The Ark Fentanyl Assay extends the timeframe in which fentanyl and norfentanyl can be detected, enabling clinicians to triage patients more appropriately, the company added.
According to Siemens, many healthcare facilities done have fentanyl testing on their assay menu, compromising the ability of patients to seek detox support, while insurers often require a positive drug test to cover treatment costs.
"Fentanyl testing provides necessary clinical information for more effective patient care where a gap currently exists," Siemens Healthineers President of Laboratory Diagnostics Deepak Nath said in a statement. "Adding the ARK Fentanyl Assay to the Atellica Solution menu offers laboratories an extensive drugs-of-abuse testing menu, which can be run efficiently on a single instrument."
The assay can also be used on other Siemens clinical chemistry analyzers, including the Viva Systems, Dimension, and Dimension Vista Systems.