A Diagnostics & Imaging Week

Transgenomic (Omaha, Nebraska) reported that it has renewed a collaboration with Fiuotecnica S.r.l. (Metaponto, Italy) to develop a genetic panel assay to predict the risk of cardiovascular disease and heart attacks using Transgenomic's WAVE System. Transgenomic will supply its WAVE technology and related reagents to Fiuotecnica.

Upon completion of the assay development, Fiuotecnica will retain rights to market the cardiovascular panel in Italy, while Transgenomic will obtain rights to market the assay in the rest of the world.

Dr. Antonio Mele, CEO of Fiuotecnica, said his company has evaluated other platforms, "but we believe that Transgenomic's unique technology platforms, including the WAVE System for DHPLC analysis and Surveyor Nuclease, provide the highest sensitivity for mutation detection. Our decision to work with Transgenomic as a partner has been affirmed by the Italian Ministry of University and Research, which is supporting this important work."

Craig Tuttle, CEO of Transgenomic, said, "Fiuotecnica's choice of Transgenomic as a partner to develop this cardio panel provides further validation of our core technologies in the European market, where we have always enjoyed an advantage." He said the assay to be developed "will be an important addition to our Transgenomic Laboratories' CLIA genetic screening offerings to hospitals and clinicians."

Transgenomic provides products, discovery and laboratory testing services to the academic and medical research, clinical and pharma markets for automated genetic variation and mutation analysis.

Rcadia's COR analyzer FDA-cleared

Rcadia Medical Imaging (Haifa), a developer of computer-aided diagnostic software, reported receiving FDA clearance for its COR Analyzer I, used to assist in screening triage patients for coronary artery disease (CAD).

The COR Analyzer I and COR Analyzer II software packages use image processing algorithms to analyze CT Angiography (CTA) studies to provide fast, accurate identification of CAD.

"Particularly in the ER … the Rcadia COR Analyzer software, which works hand-in-hand with CTA images, enables highly accurate identification of coronary artery disease as the cause for chest pain," said Dr. Anna Chacko, vice chairman of the division of radiology at Boston Medical Center.

Chacko added: "CTA is being rapidly adopted to triage patients in ERs across the U.S. Rcadia's COR Analyzer II … streamlines patient care and prevents unnecessary delays in diagnosis and treatment."

In a recent pilot study, Rcadia COR Analyzer I and COR Analyzer II packages successfully identified coronary artery disease in 100% of patients and 99% of the analyzed blood vessels.

"The real benefit of Rcadia's software is its high negative predictive (NPV) value," according to Jeff Mendel, MD, chair of the Department of Radiology at Caritas St. Elizabeth's Hospital (Boston). Mendel added that high NPV is the key to screening because it identifies true negative tests and is highly reliable in ruling out coronary artery disease.

North Med to be Misonix Czech distributor

Misonix (Farmingdale, New York), a developer of ultrasonic technology, reported international expansion of its ultrasonic neuroaspirator product line into Eastern and Central Europe via a distribution agreement with NORTH MED spol. s.r.o. for its FS1000RF Sonastar Ultrasonic Surgical Aspirator system, one of the products available under the company's Neuroaspirator line.

NORTH MED, will distribute the Sonastar Aspirator in both the Czech Republic and Slovak Republic, primarily into the neurosurgery markets of these nations.

The Sonastar enables surgeons to precisely remove both soft and hard tissue such as brain and spinal tumors, boney processes and liver tumors. The system is indicated for use in the fragmentation, emulsification and aspiration of soft and hard (i.e. bone) tissue in neurosurgery, general, gynecological, plastic and reconstructive, orthopedic, urological, thoracic, thoracoscopic, laparoscopic and gastrointestinal surgery.

Radi cites CMS FFRmyo reimbursement increase

Radi Medical Systems (Uppsala, Sweden), a manufacturer of devices in interventional cardiology, reported that CMS has approved increases in reimbursements for procedures used to measure myocardial Fractional Flow Reserve (FFRmyo). It said CMS has more than doubled reimbursement for procedures used in measuring FFRmyo in multiple artery disease.

FFRmyo can be used to assess the functional significance of coronary lesions, Radi said.

Jim Archetto, COO of Radi, said, "CMS continues to see the value in physicians assessing the extent of a patient's coronary artery disease, particularly those patients with multi-vessel disease, and then using this vital information to determine the most effective therapy for that particular patient."

Radi says its system provides measurement of FFR thermodilution derived flow (CFR) and intravascular temperature, using its single proprietary PressureWire and one instrument. The new generation of intravascular assessment products includes the PressureWire Certus coronary guide wire and the RadiAnalyzer Xpress, a mobile, diagnostic computer designed to record and display information based on the input from the PressureWire.