A Medical Device Daily
Gambro Healthcare (Stockholm, Sweden), the renal services specialist operating as an independent company since last summer, is changing its name to Diaverum. Gambro Holding sold Gambro Healthcare to the private equity firm Bridgepoint Capital in July.
Dag Andersson, formerly of Molnlycke Healthcare (G teborg, Sweden), was named CEO of the company, effective yesterday.
“As a stand-alone company with a 100% focus on renal services and clinic operations, we ... can work even harder to provide our patients and other stakeholders with the absolute best renal services,” said Andersson. “I [am] excited to become part of a leading healthcare company focusing solely on service. I am looking forward to ... growing this business over the coming years.”
Gambro Healthcare has been one of the world’s leading providers of renal services for more than 15 years and reports having a patient base of 13,000 worldwide.
The company said the new name, Diaverum, has two key facets. The first part, “dia,” represents the firm’s core activity, dialysis, and signals that Diaverum focuses exclusively on renal services. The second part, “verum,” means “truth” in Latin.
“Hence,” said the company’s announcement, “this new name is symbolic of the honesty, transparency and reliability that the company will continue to be known for.”
The company said that while the name is changed, “for the patients, everything else will stay the same. The treatment will proceed as usual, and the nurses, doctors and other clinic personnel will be the ones that the patients know and trust already.”
Diaverum said that with the number of patients with kidney failure increasing globally, “[We] will respond to the need for further dialysis capacity by expanding our operations around the globe.”
“As renal service specialists we will continue to build on our global knowledge and our dedication to continuous improvement. Our goal is to provide the best renal services available – assuring superior medical outcomes, considerate personalized patient services and support, as well as streamlined and professional clinic operations,” says J rgen Hegbrant, MD, senior medical director and VP of medical operations.
The name change to will be implemented throughout the company’s clinics over the coming year. Diaverum is the second-largest corporate provider of dialysis care services in Europe, with 170 clinics in 14 countries serving more than 13,000 patients. It has ancillary businesses in South America and Australia.
Swedish firm plans cardiac marker test
Amic (Uppsala, Sweden) reported that it has been granted a non-exclusive license by Roche Diagnostics (Basel, Switzerland) to commercialize a point-of-care (POC) test for NT-proBNP on the European market. Terms of the licensing deal were not disclosed.
NT-proBNP is a marker for a broad array of cardiovascular conditions, including the diagnosis and management of heart failure and risk stratification of patients with acute coronary syndrome.
Amic is a private POC diagnostic company with R&D and manufacturing facilities in Uppsala. The company is developing what it calls the “next generation” of POC diagnostic tests, using its microfluidic technology. The technology uses a molded plastic device called the 4castchip, and an optical detection system for “precise and sensitive quantification of immunoassays.”
The marker-specific test cartridge contains the 4castchip in a user-friendly format for rapid analysis of whole-blood patient samples at the point of care. The Forecast Reader is a low-cost analyzer designed for operation in hospital and primary care settings, with full connectivity to laboratory information systems.
“This agreement with Roche Diagnostics marks a major milestone in Amic’s development,” said CEO Lars Gunneflo. “The NT-proBNP test will be one of the first to be launched on our Forecast POC diagnostic system.”
He said that the market for NT-proBNP testing is “growing significantly in Europe, and we see great potential in the future for monitoring and managing the treatment of heart failure patients at the point of care.”
Gunneflo said the company intends to launch the Forecast POC Diagnostic System with test kits for the cardiac markers NT-proBNP and cTnI.
Osmetech seeks 510(k) clearance for test
Osmetech (London) an international molecular diagnostics business announces that it has submitted its eSensor 2C9/VKOR test to the FDA for 510(k) clearance. The test is to be used as an aid in the identification of patients at risk for increased sensitivity for the widely used blood-thinning drug, warfarin.
Osmetech said that clinical studies were performed at three evaluation sites in the U.S. using the company’s eSensor XT-8 instrument. These followed pre-clinical studies completed in November 2007. More than 340 samples were tested using Osmetech’s eSensor 2C9/VKOR method and were found to be in 100% agreement with results from bi-directional DNA Sequencing.
Warfarin is the second-most-likely drug, after insulin, to send Americans to the emergency room, resulting in an estimated 43,000 ER visits a year in the U.S. A recent economic study concluded that widespread use of warfarin testing in the U.S. could avoid 85,000 serious-bleeding events and 17,000 strokes a year, and save about $1.1 billion annually.
In August 2007, the FDA approved updated labeling for Coumadin (generic name warfarin) requiring manufacturers to explain that an individual’s genetic makeup may influence how they respond to the drug and influence optimal dosing.
James White, CEO of Osmetech said, “We believe that the Osmetech eSensor 2C9/VKOR warfarin test has many key attributes which should lead to commercial success in this growing and significant market.”
Osmetech is an AIM-listed public company on the London Stock Exchange. The company has operations in Boston and Pasadena in the U.S., serving the molecular diagnostic market targeting hospitals and reference laboratories. Osmetech has launched eSensor, an FDA-cleared electrochemistry-based array system, for Cystic fibrosis carrier detection, and it said it will launch a number of genetic and pharmacogenomic assays utilizing its proprietary technology “in the near future.”