-Now for Exclusion of Venous Thromboembolism- LEXINGTON, Mass., Aug. 28
LEXINGTON, Mass., Aug. 28 /PRNewswire/ -- Instrumentation Laboratory (IL)
today announced that the US Food and Drug Administration (FDA) has granted
510(k) clearance to expand the intended use for the HemosIL D-Dimer assay to
exclude venous thromboembolism (VTE) in outpatients suspected of deep venous
thrombosis (DVT) and pulmonary embolism (PE), when used in conjunction with a
clinical pretest probability (PTP) assessment model. HemosIL D-Dimer was
originally released in 1998, for the quantitative determination of D-Dimer in
human citrated plasma and in 2005 was FDA cleared for use as an aid in the
diagnosis of VTE.
As a part of the 510(k), IL performed a multi-center clinical study
involving more than six-hundred patients in four different hospitals,
according to a strict protocol reviewed through the FDA. Using a cut-off
value of 230 ng/mL, the Negative Predicative Value was 100% for DVT and PE on
the ACL TOP(R) Hemostasis Testing System and 100% for DVT and 99.1% for PE on
the ACL ELITE(R) system.
In 2007, the FDA granted clearance for the same VTE exclusionary claims
with IL's second-generation HemosIL D-Dimer HS assay. Both assays now have
proven clinical performance for the exclusion of DVT and PE when used with a
PTP assessment model and share the same cut-off value.
"This expanded intended use for our D-Dimer assay allows IL to provide the
tools healthcare professionals need to more accurately and efficiently
rule-out patients suspected of DVT and PE, regardless of the size of their
institution or the throughput of their analyzers," said Giovanni Russi,
Director of Worldwide Marketing, Hemostasis Reagents at IL. "We are
passionate about developing innovative products and offering all of our
customers a full range of solutions through our comprehensive portfolio of
hemostasis reagents and instruments."
HemosIL D-Dimer is fully automated on ACL systems, with time to results in
less than seven minutes. It was the first D-Dimer test automated on IL's ACL
systems and since its launch, much has been published about its excellent
performance for the diagnosis of both DVT and PE.
About VTE
DVT occurs when a blood clot forms in a large vein, usually in a leg. A
potentially fatal PE happens if the blood clot breaks loose, migrates to the
lungs and blocks a pulmonary artery or one of its branches. These conditions
can occur after any surgery, as well as in patients with spinal fractures and
spinal-cord injury, though it is most commonly seen in patients who have
recently undergone orthopedic surgery. Two hundred thousand new cases of DVT
and PE occur in the US annually and 20% suffer sudden death as a result of PE.
Learn more by visiting www.preventdvt.org
Instrumentation Laboratory ( www.ilus.com ), founded in 1959, is a
worldwide developer, manufacturer and distributor of in vitro diagnostic
instruments, related reagents and controls for use primarily in hospitals and
independent clinical laboratories. The company's product lines include
critical care systems, hemostasis systems and information management systems.
IL's GEM(R) product offerings, part of the critical care line, include the new
GEM Premier 4000 analyzer with Intelligent Quality Management (iQM(R)), GEM
Premier(TM) 3000 analyzer, GEM OPL(TM), a portable whole blood CO-Oximeter and
the GEM PCL Plus, a portable coagulation analyzer. IL's hemostasis portfolio
includes the ACL TOP(R) Family of Hemostasis Testing Systems, fully automated,
high-productivity analyzers, including the ACL TOP and the new ACL TOP 500
CTS. IL also offers the ACL ELITE(R) and ELITE PRO, other hemostasis
analyzers and the HemosIL(R) line of reagents. IL is based in Lexington,
Massachusetts.
SOURCE Instrumentation Laboratory (IL)
