A new blood test to identify heart failure patients in most dire need of treatment when they turn up at an emergency room complaining of shortness of breath proved better than current tests, according to results of a study unveiled on Tuesday.
The pivotal trial of the test developed by privately held German company Brahms AG succeeded in its goal of demonstrating superiority over tests considered the current gold standard.
"I think that this is clearly significantly better than what we have now," Dr. W. Frank Peacock of the Cleveland Clinic, one of the study's lead investigators, said in an interview. "It raises the bar."
The Brahms test was approved for use in Europe on October 1. Nils Morgenthaler, the company's vice president for global medical affairs, said this study would be part of a package Brahms will submit to the U.S. Food and Drug Administration by the end of this year as it seeks approval in the world's biggest market.
"If approved in the U.S., the MR-proADM test will help ensure patients are accurately diagnosed and rapidly receive the treatment they need," Peacock said.
Results of the study were presented at the American Heart Association scientific meeting in New Orleans.
Morgenthaler said the company would be open to licensing its test to one of the larger diagnostic companies, such as Roche Holding AG. He also said Brahms was likely to become a public company in the foreseeable future.
The Brahms test uses a biomarker it discovered called MR-proADM (Mid-Regional pro-Adrenomedullin). The 1,641-patient study called Bach compared its accuracy in predicting patients likely to die of heart failure within 90 days with that of currently used tests known as BNP and NT-proBNP.
The Brahms heart failure test had a 73.1 percent accuracy rate compared with 60.6 percent for the BNP test and 63 percent with the NT-proBNP test. The results were deemed to be statistically significant.
Peacock called the MR-proADM accuracy data "way better than I expected. This is an important change."
Doctors said heart failure can be difficult to diagnose in the emergency room setting.
Only about a third of people who come to emergency rooms due to shortness of breath actually have heart failure — a condition in which the heart is unable to pump blood efficiently enough to supply the body's needs — Peacock explained. Others may have pneumonia or lung disorders.
But patients identified with serious heart failure need more immediate treatment and likely need to be admitted to the hospital.
"These patients deserve the most aggressive interventions and warrant close surveillance," said Dr. Stefan Anker of the Charite Medical School in Berlin, who presented the data at the AHA meeting.
"Biomarkers that can help the physician identify these patients can improve the patients' quality of life and help direct resources and hospital therapies where they are needed most," Anker said.
A third of the patients tested in the study were suffering from heart failure and 10 percent of them were dead within 90 days, researchers said.
Asked if the Brahms test should become standard emergency room practice in patients complaining of shortness of breath, Peacock said: "This falls under the category of no brainer."