Stago receives FDA approval for automated, highly sensitive D-dimer test

Sep 17 2014

The first assay to meet the new CLSI H59-A* standards for exclusion of pulmonary embolism

Stago has received approval from the US Food and Drug Administration (FDA) for the reagent STA^® -Liatest^® D-Di, in the exclusion of pulmonary embolism (PE) in patients with low or moderate risk, presenting at an emergency unit. FDA requirements for D-dimer assays for exclusion are now based on the new and more restrictive standards established and published by the Clinical Laboratory Standards Institute (CLSI, H59-A). Stago’s rapid, automated and highly sensitive D-dimer is thus the first test to comply with these new requirements.

In order to comply with the new CLSI guidelines, Stago performed a 2-year, international, prospective study, similar to clinical studies performed in the pharmaceutical field (9 sites, 5 countries, more than 1100 patients, including evaluation of clinical pretest probability, imaging and 3 months of follow-up): a first in the field of Haemostasis diagnostics.

As its coordinator, Prof. Gilles Pernod (Grenoble University Hospital, France) pointed out:

As well as providing the results required to validate this test for the exclusion of PE, this study brought to light a significant evolution of clinical practices and shifts in prevalence. In fact, these results will be presented in some interesting upcoming publications.

This study also confirmed the excellent diagnostic performance of the STA^® -Liatest^® D-Di assay, with a very high negative predictive value (NPV) for the exclusion of PE, far exceeding FDA requirements (>99.7% versus 97%), and excellent sensitivity (>97% versus 95%).

Stephane Zamia, PhD, CEO of Diagnostica Stago, Inc. explains:

STA^® -Liatest^® D-Di is the first D-Di assay to report comprehensive study data that focuses on US-specific care patterns in the package insert. Increases in FDA stringency raises the bar for demonstration of clinical utility and patient safety. Stago is proud for STA^® -Liatest^® D-Di to lead the way once again and set the standard for D-dimer assays.

The second part of this international clinical study, concerning deep vein thrombosis (DVT), is underway and is due to be completed in the next few months. Let us hope that it provides the scientific community with as much relevant data as this first essential phase.