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FDA Clears Response Biomedical's Heart Failure Dx Test

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has cleared a Response Biomedical point-of-care test that serves as an aid in diagnosing heart failure, the company said today.
The RAMP NT-proBNP test identifies the marker for BNP, which is secreted from the heart’s left ventricle in response to pressure overload, and it regulates blood pressure, electrolyte imbalance, and fluid volume.
Elevated levels of the NT-proBNP indicate heart failure, and can be used for early detection and management, according to Vancouver, BC-based Response Biomedical.
The test “supports the drive for speed and accuracy of diagnosis for patients presenting in emergency rooms and for early detection in ambulatory care,” said Response Biomedical CEO S. Wayne Kay.
Kay also said that the test is “clinically concordant” with Roche’s Elecsys proBNP test, allowing hospitals to standardize their decisions based on tests from their emergency rooms and central labs.
Affecting nearly 17 million people worldwide, heart failure is “the single most frequent cause of hospitalization in people over 65 years,” the company said.
Response Biomedical recently granted Roche Diagnostics the rights to market its cardiovascular point-of-care tests.  

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