The Siemens Healthcare
Diagnostics D-dimer assay for the company’s Stratus CS Acute Care Diagnostic
System has been cleared by the FDA to exclude pulmonary embolism (PE) in
conjunction with a non-high clinical pretest probability (PTP) assessment model
in point-of-care. Currently, this is the only assay available in the U.S. to achieve
this clinical validity for use in the point-of-care setting.
Studies show that elevated
D-dimer levels, which are indicative of reactive fibrinolysis, correlate with a
variety of clinical conditions, including PE. PE results when a blood clot from
another part of the body, such as the arms or legs, breaks loose (embolizes)
and travels through the blood stream to the lungs, where it can block the
pulmonary artery.
The expanded use of the
Stratus CS system D-dimer test to quickly exclude PE helps physicians at the
point-of-care provide a more timely assessment in acute situations. Combining a
sensitivity of 97% and a negative predictive value (NPV) of 98% with the precision
and speed assets of the Stratus CS system allows clinicians to have greater
confidence, translating to better patient management. Further, results are
available in as little as 14 minutes, and testing can be run on the same tube
as other Stratus assays, eliminating the need to collect additional tubes or
split samples.
“Clinicians in acute care are challenged to make timely decisions that can
literally mean the difference between life and death for their patients,” says
David Stein, PhD, CEO, Point of Care Business Unit, Siemens Healthcare
Diagnostics. “Siemens is excited to be the first company to offer a test for PE
exclusion at the point of care to help these physicians obtain the fast,
accurate results that they need to guide critical clinical decision-making.”
Siemens Healthcare Sector, www.siemens.com/healthcare
Filed Under: Drug Discovery
