IRIS International to Present NADiA ProsVue at Two Important Meetings in Washington DC Addressing the Role of Advanced …

Posted: September 21, 2012 at 12:11 pm

CHATSWORTH, Calif., Sept. 20, 2012 (GLOBE NEWSWIRE) -- IRIS International, Inc. (IRIS), a leading manufacturer of automated in-vitro diagnostics systems and consumables, and a provider of high value personalized medicine solutions today announced that IRIS has received the honor of being asked to speak at two upcoming important meetings: AdvaMedDx's Hill Briefing on "The Role of Advanced Diagnostics in Cancer Care" and the Eighth Annual Summit of the Prostate Health Education Network, Inc.

Cesar M. Garcia, Chairman, President and Chief Executive Officer of IRIS International will present the benefits of NADiA ProsVue, a prognostic prostate cancer test, today at a Capitol Hill briefing sponsored by AdvaMedDx. Held in conjunction with the House Medical Technology Caucus, this briefing will explore how advanced diagnostics are delivering on the promise of personalized medicine. AdvaMedDx represents the world's leading diagnostics manufacturers to advocate for the power of medical diagnostic tests to promote wellness, improve patient outcomes and advance public health in the United States and abroad.

Also today, Dr. Jason Alter, Vice President of Marketing for the Iris Personalized Medicine division will present NADiA ProsVue and advances in prostate cancer prognostic testing at the 8th Annual African American Prostate Cancer Disparity Summit sponsored by the Prostate Health Education Network, Inc. (PHEN) in Washington DC. PHEN is a non-profit organization with a primary mission to increase prostate health education and awareness. The organization focuses on men in the highest risk group for prostate cancer, including African Americans and men with family history.

"We are pleased that important organizations, such as AdvaMedDx and PHEN, are fostering education and understanding of the critical role of diagnostic advances in the management of patients with prostate cancer," said Cesar M. Garcia. "We believe that NADiA ProsVue will be extremely helpful in identifying low risk patients, thus avoiding unnecessary treatments and their resultant side effects, as well as reducing anxiety for patients and costs to the healthcare system."

NADiA ProsVue is an in-vitro diagnostic assay for determining rate of change of serum total prostate specific antigen (tPSA) over a period of time. A retrospective clinical study of 304 patients evaluated the slope of three successive ProsVue tests over a period of at least ten months after a prostatectomy to identify prostate cancer patients with no evidence of disease or clinical progression. Recurrence of disease was determined by positive imaging, biopsy results or prostate cancer related death.

The study resulted in a negative predictive value (NPV), or the proportion of patients correctly identified as stable, of 92.7% and a positive predictive value (PPV), or proportion of patients correctly identified as recurring, of 78.0%. Consequently, a ProsVue slope of equal to or less than 2.0 pg/mL per month in the first year following radical post-prostatectomy was highly associated with no evidence of disease over the long-term follow up.

NADiA ProsVue received 510(k) clearance from the FDA and CE Mark approval in the fall of 2011 and is the first assay to receive FDA clearance based on linear slope of tumor marker concentrations over time. Currently, Iris Personalized Medicine is conducting a Field Experience Trial designed to show how NADiA ProsVue impacts clinical decision-making and potentially optimizes healthcare costs while reducing patient morbidity from unnecessary adjuvant treatment post-radical prostatectomy.

NADiA ProsVue is available through Iris Personalized Medicine's high complexity CLIA-certified laboratory. For more information on NADiA ProsVue, please visit http://www.irispermed.com.

About the NADiA Technology Platform

NADiA technology, Nucleic Acid Detection Immunoassay, is a molecular diagnostics platform targeting the early detection of proteins associated with cancer and infectious diseases utilizing a novel ultra-sensitive and precise method. NADiA combines immunoassay and real-time Polymerase Chain Reaction (PCR) methodologies, or Immuno-PCR, with the potential to detect proteins with femtogram/milliliter sensitivity (10-15 gram/milliliter). As NADiA has the ability to effectively measure extremely low concentrations of proteins, which may be under the detection threshold of current immunoassay methods, it has the potential to provide better therapeutic outcomes for patients.

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