Peer Review Studies Find Decipher® Genomic Test Significantly Changes Postoperative Treatment Recommendations for Prostate Cancer Patients and Increases Confidence in Treatment Decisions

SAN DIEGO, May 14, 2014 /PRNewswire/ -- GenomeDx Biosciences today announced data from two new clinical utility studies demonstrating that Decipher® Prostate Cancer Classifier significantly changed treatment decisions and increased confidence in treatment decision-making for men considering adjuvant therapy following prostate surgery. The studies are being published in upcoming issues of the journals Current Medical Research and Opinion (CMRO) and the British Journal of Urology International (BJUI), respectively.

"The American Urological Association has issued clinical guidelines recommending adjuvant radiation therapy to all prostate cancer patients with adverse pathology after surgery, despite that most men in this group did not develop metastasis or die of prostate cancer," noted John Hornberger, M.D., Principal of Cedar Associates, LLC, adjunct faculty at Stanford and senior author on the study published in CMRO. "By providing a more objective, individualized estimate of metastasis risk based on a quantitative laboratory assay, adoption of the Decipher prostate cancer test may reduce inappropriate or inconsistent use of adjuvant treatment in this population."

In the PRO-ACT study published in CMRO, 15 board-certified, community-based urologists who had ordered the Decipher test to inform management of their current patients were asked to provide treatment recommendations before and after receiving their patients' Decipher test results and then complete a decision conflict scale, a measure designed to assess confidence in treatment recommendations. Prior to receiving the Decipher test results, physicians were asked to make treatment decisions based on clinical risk factors such as Gleason score and tumor stage. Following the receipt of Decipher results, physicians changed their treatment recommendations for 30.8 percent of patients (95% CI, 23-39%). Among the 102 patients for whom observation was initially recommended, physicians changed recommendations to adjuvant radiation for 18 of those patients. Conversely, 17 of the 40 patients who were initially slated for adjuvant radiation saw recommendations change to observation. The genomic information provided by Decipher test results significantly influenced which patients were recommended adjuvant treatment (p<0.001). In addition, decisional conflict with regard to physicians' decision to treat with adjuvant radiation therapy was significantly less with the use of Decipher results than without (p<0.0001).

"Making secondary treatment decisions after our patients have had surgery is not cut and dry.  Most men who do not need additional treatment would prefer to avoid the side effects," said Ketan Badani, M.D., urologic oncologist at Columbia University in New York. "The ASSESS-D study clearly demonstrates that adding a test like Decipher, that gives physicians a readout of the genomic fingerprint of a patient's prostate cancer and provides a more precise measure of the biologic risk of developing metastasis, can help physicians make more appropriate treatment decisions, and be more confident in those decisions."

In the ASSESS-D study, a multi-center, prospective decision impact study published in BJUI, 51 community urologists reviewed and provided adjuvant treatment recommendations for randomly selected patient cases considered by clinical practice guidelines to be high risk for metastasis following prostate surgery.  Overall, 31 percent (95% CI: 27-35%) of treatment recommendations were changed after reviewing the Decipher results. Among adjuvant radiation therapy recommendations without Decipher results, 40% (n=77) changed to observation (95% CI: 33-47%) following knowledge of Decipher results. For patient cases recommended for observation, 13% (n=38) (95% CI: 9%-17%) were changed to adjuvant radiation therapy with Decipher. Case histories with low Decipher results were recommended observation 81% of the time (n=276), while for those with high Decipher results, 65% were recommended for treatment (n=118, p<0.0001). Treatment intensity was strongly correlated with the Decipher-predicted probability of metastasis (p<0.001) and the Decipher test was the dominant risk factor driving decisions in multivariable analysis (OR=8.6, 95% CI: 5.3-14.3%, p<0.0001).

About Decipher

The Decipher® Prostate Cancer Classifier directly measures a patient's biological risk of developing metastatic prostate cancer. By assessing the activity of multiple genomic markers associated with metastatic disease, Decipher provides information about the aggressiveness of a patient's tumor - information distinct from that provided by PSA and other clinical risk factors. Decipher continues to demonstrate that it can accurately predict aggressive disease and help physicians make more informed treatment decisions for men with prostate cancer.

Decipher is covered by multiple private insurance plans and is available to eligible US patients through their physicians.  To learn more about ordering the Decipher test please visit www.deciphertest.com.

About GenomeDx Biosciences

GenomeDx Biosciences is focused on transforming patient management by putting usable genomic information in the hands of patients and their physicians. GenomeDx has developed the Decipher® Prostate Cancer Classifier, the first and only commercially available genomic test that predicts the risk of developing metastatic prostate cancer independently of PSA and other conventional risk assessment tools. GenomeDx is based in San Diego, California and Vancouver, British Columbia. To learn more visit www.genomedx.com

SOURCE GenomeDx Biosciences

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ZIO ® service identifies arrhythmias significantly more than the traditional Holter Monitor, according to study published online in the American Journal of medicine

SAN FRANCISCO, 02 January 2014/PRNewswire /-iRhythm Technologies, a company of services of health information, today announced that a prospective study from the Scripps Translational Science Institute (STSI) has found that the use of the service of the company ZIO significantly increased detection of cardiac arrhythmias, compared to the use of the traditional Holter monitor. Findings, published and made publicly accessible online in the January issue of the American Journal of Medicine, underscore the role of the service ZIO, ZIO, patented algorithms patch and ZIO review, as the new standard for the ambulatory monitoring of patients with suspected arrhythmia.

"This is the first large prospective validation that this new technology passed the device invented by Norman Holter in 1949," said the lead author of the study, Dr. Eric Topol, a cardiologist who directs STSI and serves as the academic director of Scripps Health. "By tracking every beat of the heart up to two weeks, ZIO service proved to be significantly more sensitive than the Holter standard, it uses multiple threads and it is normally only used or tolerated during 24 hours.

"For" millions of people who presented each year with suspected arrhythmia, this could to be the new standard for the capture of the electric guilty heart rhythm disturbance, most commonly atrial fibrillation that carries a significant risk of race, he said.

The prospective study included 146 consecutive patients of Scripps Health who were referred for evaluation of cardiac arrhythmias and underwent an outpatient monitoring simultaneous ECG with ZIO patch, a patch on the chest, which continuously monitor the heartbeat records up to 14 days and a conventional 24-hour Holter, a portable machine with multiple cables that connect to the electrodes on the chest. Total wear of both devices, the service of ZIO time detected events of arrhythmia 57% more in comparison with the Holter monitor (96 against 61), mainly due to the prolonged monitoring. The doctors also reported that they reached a definitive diagnosis in 90% of cases using the ZIO service, compared with 64% with the Holter monitor. In addition, 81% of the patients reported that they preferred the ZIO patch versus the Holter monitor.

"The traditional options of monitoring heart are limited in their ability to capture the arrhythmias, which are rare and often do not have symptoms, and because they are difficult for patients to comply", said Kevin King, President and Chief Executive Officer of iRhythm. "These studies findings underscore that the ZIO service is setting a new standard for the diagnosis of arrhythmia, with a focus continuous monitoring proven, long-term which allows doctors to rule in and rule out arrhythmias before in the way of diagnosis and change the treatment of the patients."

Each year, millions of patients presenting with low common and non-specific symptoms such as palpitations, dizziness, and shortness of breath, which may or may not be caused by cardiac arrhythmias. Reports estimate that the three most common types of arrhythmia, atrial fibrillation (AF), bradycardia and ventricular tachycardia - affect approximately 8 million people in the United States each year. If it is not correctly, arrhythmias can lead to serious complications such as stroke. Effective management of cardiac arrhythmia is specific to the identified type of arrhythmia. Arrhythmias, however, are often difficult to diagnose using techniques of monitoring current, that they are limited in what you can record or it can be difficult for patients to use or tolerate.

About ZIO service
Service ZIO, ZIO, patented algorithms patch and ZIO report, is recognized more and more as the new standard for patients with suspected arrhythmia ambulatory cardiac monitoring. ZIO patch is a non-invasive, resistant to water, which is easy to use and discreet to wear, high compliance of the patient and a higher diagnostic yield. Proprietary algorithms analyze the data hit captured heart and provides a concise report to the patient's physician. Since its commercial launch in 2011, has been ZIO service with more than 200,000 patients in nearly 800 institutions throughout the country. ZIO is covered by most Medicare patients and main payers private throughout the country, representing more than 150 million of lives covered.

About iRhythm Technologies, Inc.
iRhythm is a company of services of health information that aims to be the world leader in information of cardiac arrhythmia management, a large and growing clinical need. Your solution of ship logo, ZIO service, offers an approach proven for continuous monitoring in the long term that allows early diagnosis in the clinical way to improve patient outcomes and reduce healthcare costs. For more information, visit www.irhythmtech.com.

Press contact:

Tracy Morris
650-380-4413
tracymorrispr@gmail.com

SOURCE iRhythm Technologies

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