Imagify missed non inferiority on specificity

Acusphere imaging agent succeeds on 2 of 3 goals

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By Bill Berkrot

canada goose store NEW YORK, May 1 (Reuters) Acusphere Inc. canada goose store

But Acusphere shares fell 33 percent as the agent, Imagify, fell short on one measure.

uk canada goose Imagify, showed superior sensitivity, or ability to detect heart canada goose outlet canada disease, and was non inferior canada goose outlet in vancouver in overall accuracy compared with nuclear tests in the study. Imagify missed non inferiority on specificity, or the ability of ultrasound readers to detect a lack of disease. uk canada goose

Friedman, Billings, Ramsey analyst Robert Uhl downgraded his rating on Acusphere shares to perform from saying, have concern that these mixed canada goose outlet mississauga results will led to an uncertain regulatory outlook for this product. approval and suggested the stock sell off was unjustified.

Canada Goose Outlet get canada goose jacket uk FDA approval what they have to do is hit the primary end point and the primary end point canada goose outlet 2015 is accuracy and canada goose outlet real they hit that, said Andrew Forman, an analyst for WR Hambrecht, who believes Imagify to be canada goose outlet in new york superior to nuclear stress tests. Canada Goose Outlet

canada goose uk black friday was phenomenal with Imagify, canada goose victoria parka outlet he said. canada goose uk black friday

Canada Goose Jackets Nuclear stress tests, which use a radioactive agent to measure blood flow, are currently the most frequently used imaging procedure for detecting coronary artery disease. They measures perfusion, or canada goose outlet near me blood flow in the heart muscle, which is considered a sensitive indicator of coronary artery canada goose jacket outlet disease. Canada Goose Jackets

canada goose uk shop Angela Larson, an analyst with Susquehanna Financial Group, agreed that Wall Street might be confused about the results. canada goose uk shop

Canada Goose Coats On Sale think canada goose parka uk the company has to continue to educate the Street on goose outlet canada how to read these studies, she said. bottom line is when you look at the product and compare it with the alternative, this is a great opportunity for patients. health regulators in the fourth quarter of this year. Acusphere Chief Executive Sherri Oberg said she believes Imagify could garner more than $2 billion a year in a rapidly growing cardiac diagnostic market. Canada Goose Coats On Sale

canada goose factory sale Dr. Roxy Senior, canada goose outlet black friday sale one of the study researchers, was enthusiastic about the results and potential for Imagify. canada goose factory sale

is significantly more superior in picking up the disease and it is as accurate as nuclear, Senior said.

canada goose coats really Cheap canada goose a groundbreaking technique because never ever have we been able to look a perfusion at the bedside so easily with an ultrasound machine, said Senior, director of cardiac research at Northwick Park canada goose outlet location Hospital outside London. canada goose coats

He said ultrasound is used to assess heart canada goose outlet parka structure and function but had been unable to measure blood flow as an indication of coronary artery disease.

uk canada goose outlet used to be called the holy grail of echocardiography and we have achieved canada goose outlet winnipeg that, he added. uk canada goose outlet

Canada Goose online Senior said canada goose outlet vancouver the Acusphere agent provides advantages over nuclear testing in that the entire process takes about 20 minutes and involves no radiation, while nuclear testing can canada goose factory outlet take three to five hours to reach a diagnosis. He also noted that ultrasound equipment is much more widely available and far less expensive to use. Canada Goose online

buy canada goose jacket cheap a tremendous combination, Senior said, adding that it is not only far more convenient for patients but many more tests can be performed each day. buy canada goose jacket cheap

Results of the trial were broken canada goose outlet niagara falls into three categories with all patients included in the accuracy measure, which the company believes canada goose jacket outlet uk is the goal on which the Food and Drug Administration will focus.

Patients with heart disease were included flos medicinae generic cialis. under the sensitivity assessment and tests of patients without disease were used for the specificity measure, in which Imagify failed to achieve the goal of non inferiority to nuclear.

canada goose black friday sale Senior said sensitivity was far more important than specificity as you don want to miss the disease. canada goose black friday sale

canada goose uk outlet Serious adverse events were reported in six of 457 patients in the study. The company declined to specify what the serious problems were but said none were life threatening canada goose uk outlet.

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