A Medical Device Daily

Market revenues for immunohistochemistry (IHC) diagnostics are set to increase across Europe from $34.8 million in 2004 to $48.1 million by 2011 at an estimated compound annual growth rate of 4.7%, according to a new report from Frost & Sullivan (F&S; London).

The advent of new generation molecular diagnostic tests that can detect cancer in its earliest stages or gauge a person's predisposition to the disease has propelled IHC to the forefront of cancer diagnostics, according to the new report. And it says that with recent campaigns in Europe encouraging people to test themselves for certain subtypes of cancer, IHC diagnostics clearly needs to focus on early disease detection and treatment.

“Timely disease detection offers compelling advantages such as reduced need for expensive therapies, invasive procedures and potentially harmful imaging techniques,“ says F&S research analyst Dr. Fiona Rahman. “This in turn brings down bed occupancy rates and reduces the burden on the healthcare system, driving governments to implement national cancer screening programs across Europe.“

Rahman noted that the IHC diagnostics market in Europe is highly competitive and dominated by a few major manufacturers, with intense competition producing better customer service standards, and thus the need for more attention on comprehensively educating end users of their products. This calls for increased investment in training company sales representatives and field specialists within the clinical setting.

Budgetary constraints of laboratories could also pose a strong challenge to IHC test manufacturers. Laboratories typically prefer low-priced concentrations rather than expensive, standardized, per-diluted reagents and are inclined to use traditional methods of H+E staining because of the comfort factor. This trend is prevalent in countries such as Germany, where the market is largely price driven, according to F&S.

IHC tests are more expensive than traditional testing methods due to higher technological content and improved specificity and sensitivity. Performing a nucleic acid test not only entails a superior technical preparation, but also requires more time from the technician, thus adding to the cost.

“As a result, companies need to improve the automation of these tests radically to be competitive with more conventional and cost-effective technologies,“ Rahman said. “The automation and integration of IHC technologies in larger analyzers already offering other technologies is likely to be realized towards the end of the forecast period.“

The report also notes resistance from the medical community despite the many advantages of IHC products and ongoing technological innovations. In the UK and France, for instance, there is considerable reluctance to adopt new methods of diagnosing, treating and managing patients without any verification of their value addition in terms of patients' well being and cost considerations.

“While physicians are reluctant to experiment with expensive IHC products, they are nevertheless essential to complement more traditional diagnostic methods as there is a technology gap and a lack of commercially available ultra-high volume and staining instrumentation,“ said Rahman. “The challenge for manufacturers, therefore, is to offer IHC products at cost-effective prices to encourage end users to experiment and successfully adopt these tests as routine diagnosis.“

Grifols buy U.S. plasma firm

Grifols (Madrid, Spain), specializing in the production of life-saving biopharmaceuticals, reported the acquisition of PlasmaCare (Cincinnati), specializing in plasma collection. The 15 dedicated plasma collection centers from PlasmaCare, located throughout the Midwest and the South will be added to the 50 plasma collection centers Grifols already has in North America. With this acquisition, Grifols said it will be the world's second largest supplier of plasma.

Victor Grifols, CEO, said, “Securing an adequate plasma collection capacity for the foreseeable future is a critical part of meeting the demand for plasma therapies on a global scale.“ The company said it is positioned as a major provider of plasma therapies to critically ill patients in more than 90 countries.

In the past four years Grifols has invested more than $300 million in U.S. production and logistics facilities, product licenses, and dedicated plasma collection operations. “The U.S. has always been a key market for the company,“ said Gregory Rich, president of the company's U.S. operations. More than 50% of the company's worldwide work force resides in the US.

Throughout 2004 and 2005, Grifols said its investments in the U.S. focused on modernizing the company's production facilities in Los Angeles, undertaken to upgrade existing facilities and standardize production processes with those in place at the company's facilities in Spain.

Micrus reports CE marking

Micrus Endovascular (San Jose, California) reported receiving the CE mark for its Courier microcatheter line and Watusi guidewire platform. The company said it will begin selling these products through its direct sales and distribution network immediately.

“These product approvals, together with our Pharos stent approval in Europe announced earlier this month, significantly expand our ability to address the neurovascular procedure market,“ said John Kilcoyne, president and CEO. “We are currently working to gain U.S. market approval for the Watusi and Courier. By expanding our product offerings, we are executing on our plan to compete for a greater percentage of the neurointerventional procedure revenue dollar.“ He added: “We believe that our Courier microcatheters and Watusi guidewires will address interventionalists' need for more predictable and secure access to the complex and distal anatomy of the cerebral vasculature.“

Micrus manufactures implantable and disposable medical devices used by interventional neuroradiologists and neurosurgeons to treat cerebral aneurysms responsible for hemorrhagic stroke.

Marshal to head quality and safety effort

Professor Martin Marshall has been named deputy chief medical officer at the UK Department of Health to be responsible for its healthcare quality and patient safety agenda. Marshall will take up his new role in May.

Professor Sir Liam Donaldson, chief medical officer of the Department of Health, said that Marshall's primary role “will be to work with me to take forward the healthcare quality and patient safety agenda with responsibility for the Healthcare Quality Directorate and professional responsibility for modernizing medical careers. Martin's particular expertise is the use of information about quality in primary care and engaging the public with health service delivery and performance.“

Marshall said: “I hope to use my experience as a clinician, academic and manager to move this agenda forward and continue to build on and improve the quality of care patients receive.

For the past six years Marshall has been principal in general practice at the Robert Darbishire Practice in Manchester. Since 2001, he has combined this role with that of professor of general practice at the National Primary Care Research Centre at the University of Manchester .