A Diagnostics & Imaging Week
Volcano (Rancho Cordova, California) reported approval of its s5i Integrated IVUS (intravascular ultrasound) System by regulatory authorities in Japan.
Volcano said it expects to launch the s5i into Japan — which it says represents the largest IVUS market worldwide — this quarter. The company noted that it has already launched the s5i Integrated IVUS system into the U.S. and Europe.
Volcano said that the s5i is its first IVUS system that can be integrated into new or existing cath labs. The company said it can now tailor an integrated IVUS solution to the unique user and workflow needs for virtually any vendor's cath lab type or configuration, including multiple controllers and monitors, as well as flexibility in the physical location of the console. The s5i also incorporates Volcano's real time VH IVUS tissue characterization functionality that enhances the interpretation of IVUS images, and ChromaFlo Stent Apposition analysis which helps physicians confirm proper stent expansion and placement.
Volcano said that the s5i IVUS is the only IVUS system to have undergone extensive safety and compatibility testing with Innova series from GE and the Axiom from Siemens. Artis FD series), Philips (Allura series), and Toshiba (Inifinix-I series).
Scott Huennekens, president/CEO of Volcano, said the approval "makes Volcano the only company to offer an integrated IVUS console to the largest worldwide IVUS market ... and believe that the lessons learned through IVUS by Japanese physicians will help increase the use of IVUS in the U.S. and Europe as well."
Ron Waxman, MD at the Washington Hospital Center, said, "We recently performed an analysis of 7,000 patients at our center and concluded that the incorporation of IVUS guidance into everyday PCI procedures can reduce the patient risk of stent thrombosis by a statistically significant margin. We have always been IVUS advocates, but these new findings have driven IVUS use at the Hospital Center to its highest level ever. I recently presented this data in Japan where it was well received as interventional cardiologists in Japan have a high usage of IVUS and low rates of stent thrombosis."
Siemens ELF test now available
Siemens Medical Solutions Diagnostics (Tarrytown, New York) reported the availability in Europe of its Enhanced Liver Fibrosis (ELF) test, which it said is "the first CE-marked, standardized non-invasive blood test for assessing the status of liver fibrosis."
The Siemens ELF test was first validated in an international multi-center study and is now available through iQur (Southampton, UK) as a testing service for patient management.
The company noted that chronic liver disease — resulting from alcoholic liver disease, fatty liver or viral hepatitis — is increasingly recognized as a major cause of morbidity and mortality. "Standard liver function tests do not accurately reflect the true extent of fibrotic damage or, in many cases, may detect it too late," Siemens said.
Liver biopsies are routinely performed to assess liver damage, or fibrosis, as well as to try to monitor the effectiveness of drugs in tackling the disease. "Performing a liver biopsy is a hazardous, expensive and painful experience for the patient and does not always provide accurate results because of difficulties in sampling and interpretation," the company said. "Fibrosis is not evenly distributed throughout the liver and because such a small amount of biological material is sampled, 55% of 15 mm biopsies may be misclassified. Larger biopsies can be performed, but even with 25 mm sections, 45% will be erroneous."
Siemens Diagnostics said that because ELF uses a blood sample rather than a biopsy, it can be used routinely for the same patient and helps monitor progression of fibrosis in the patient's liver.
"The benefit of the Siemens ELF test is that it can be used repeatedly, with minimal patient discomfort, to monitor disease progression and response to therapy," said David Okrongly, senior vice president, Molecular Business Unit, Siemens Medical Solutions Diagnostics. "It's the first standardized laboratory method for assessment of liver fibrosis which requires only a simple sample of blood. We are delighted that iQur now offers this ELF test as an incremental service for physicians managing patients with chronic liver disease."
The ELF test combines three serum biomarkers —hyalurinic acid, procollagen III amino terminal peptide and tissue inhibitor of metalloproteinase 1 — that have been shown to correlate to the level of liver fibrosis assessed by liver biopsy.
An algorithm measures each of these markers by immunoassay, to create an ELF score. Sampling for the ELF test can be performed in a physician's office or health center, avoiding the need for a patient to travel to a hospital.
Rosetta cites study on microRNA
Rosetta Genomics (Rehovot, Israel/North Brunswick, New Jersey), a microRNA company, said research findings published in the journal Molecular Cell suggest the potential for a specific, single microRNA — miR-34a — to be used as a drug candidate in cancer therapy to increase apoptosis, or programmed cell death, in the context of the tumor suppressor p53, which has been shown to prevent or slow the spread of cancer cells by facilitating apoptosis.
In this study by scientists from Rosetta Genomics and the Weizmann Institute of Science (also Rehovot), activation of p53 in vivo in mice as well as in cultured human cells induced the expression of miR-34a.
Believing that miR-34a could itself play a role in cellular apoptosis, researchers introduced miR-34a directly into human cancer cell lines to determine its impact on tumor cell behavior. They said the results "clearly demonstrated" that over-expression of miR-34a led to increased cancer cell death as well as promoted other anti-proliferative activities.
The data presented in Molecular Cell is supported by other recent studies showing that miR-34a is under-expressed in central nervous system tumors.
"This is a groundbreaking study shedding light on the critical role microRNAs play in fighting cancer and highlights their potential to act as novel drug targets," said Dr. Dalia Cohen, global head of research and development at Rosetta Genomics. "The results suggest the potential that a synthetic miR-34a-like agent could be used as a cancer therapy."
MicroRNAs are a recently discovered, naturally occurring form of RNAi. They act as protein regulators and according to Rosetta Genomics, "have the potential to form the basis for a new class of diagnostics and therapeutics."