A Diagnostics & Imaging Week

Sectra (Stockholm, Sweden) reported that it has signed an agreement with British Telecommunications (BT) to provide picture archiving and communications system (PACS) products and services to the majority of London’s public hospitals.

British Telecom is the Local Service Provider for the NHS London Program for IT and has been providing Sectra’s PACS to London trusts of the National Health Service via a former Sectra partner since 2004.

Now, Sectra, as a subcontractor to BT, will assume responsibility for the support and maintenance of the systems and also will supply additional PACS products. The 21 London trusts operate 25 hospitals that combined perform more than 4 million radiology examinations annually, Sectra said.

“This agreement confirms our ability to provide timely, first-class service and support,” said Torbj rn Kronander, president of Sectra’s medical operations. “To be chosen to take over the service responsibility of such a large group of critical radiology operations is an acknowledgement [of] our very capable staff.”

In addition to direct sales efforts, Sectra continues to offer direct PACS service and support agreements to any customers that previously purchased Sectra products through partners.

Sectra makes IT systems and products for radiology, mammography and orthopedic departments. More than 950 hospitals worldwide use its systems, performing more than 40 million radiology examinations annually.

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.

UK firm submits warfarin test to FDA

Osmetech (London), a developer of molecular diagnostics, said 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.

Clinical studies were performed at three evaluation sites in the U.S. using the company’s next-generation eSensor XT-8 instrument. These followed pre-clinical studies completed in November where 345 samples were tested using the eSensor 2C9/VKOR method and found to be in 100% agreement with results from bi-directional DNA sequencing, the company said.

CEO James White said, “We are [pleased] with the performance of our warfarin test and are confident of achieving FDA clearance to launch [the] test in the first half of 2008. We believe that the eSensor 2C9/VKOR warfarin test has many key attributes which should lead to commercial success in this growing and significant market.”

Osmetech said that in the U.S. alone, more than 30 million warfarin prescriptions were made last year, including an estimated 2 million new patients. It said 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.

According to the company, 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.

Osmetech has U.S. operations in Boston and Pasadena, California.

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.”

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