A Diagnostics & Imaging Week

Dutch diagnostics firm Qiagen (Venlo, the Netherlands) has introduced a new molecular diagnostic test to type the HLA-B*5701 allele, a genetic variation in the Human Leucocyte Antigen system.

The company said that HIV patients carrying the HLA-B*5701 marker have a 60% higher risk to develop hypersensitivity reaction (HSR) to Abacavir, which is a component of several widely marketed drugs inhibiting the reverse transcriptase of the HI virus. HSR is a serious, sometimes even fatal multi-organ syndrome that manifests itself in fever, respiratory or constitutional symptoms.

Last month, FDA advised healthcare professionals that all HIV patients should be screened for HLA-B*5701 before initiating treatment with drugs containing Abacavir. Regulatory agencies in other countries, including Germany, issued similar warnings.

The regulatory bodies responded to results from a study published in the New England Journal of Medicine earlier this year. The PREDICT1-1-Study, carried out at the Royal Perth Hospital and Murdoch University (both Perth, Australia) among 1,956 patients from 19 countries, found that HLA-B*5701 is a major biomarker for HSR.

"The screening for HLA-B*5701 prior to Abacavir treatment allows the identification of patients likely to develop HSR. Using HLA-B*5701 tests as a companion diagnostic with the drug therefore helps to better protect HIV-infected patients in treatment from severe additional suffering," said Magnus Ingelman-Sundberg, professor and head of the section of pharmacogenetics at the Karolinska Institute (Stockholm, Sweden).

Ingelman-Sundberg, who was responsible for the commentary on the PREDICT1-study in NEJM, said, "The combination of diagnostics and therapeutics is a key approach to eliminating risks of side effects and therefore increasing the efficacy of drugs."

Qiagen CEO Peer Schatz said, "Our new test is another great example for the advent of molecular diagnostic tests, which can be used to assess the efficacy of drugs. Enabling doctors to customize therapies based on molecular tests which create molecular profiles of patients or diseases ultimately leads to more medical innovation, cost efficiency and – most importantly – to better and safer treatment of patients."

The newly launched test complements a larger personalized medicine portfolio which includes molecular tests related to transplantation, cancer and other therapies.

Bruker buying surface imaging firm

Bruker AXS (Karlsruhe, Germany) reported that it has signed an agreement to acquire all of the equity of Surface Imaging Systems (S.I.S.; Herzogenrath, Germany), a company with annual revenues of about $3 million. The transaction is expected to close in 3Q08, and no further financial details were provided.

S.I.S. develops advanced atomic force/scanning probe microscopy systems (AFM/SPM) for numerous applications in materials research, including semiconductors, data storage, electronic materials, solar cells, polymers and catalysts.

AFM/SPM is a well-established method for ultra-high spatial resolution surface imaging and the characterization of surfaces down to atomic dimensions. The global SPM market had an estimated total market size of $200 million to $300 million in 2007.

S.I.S. offers a product range from bench-top high-performance AFM-only microscopes to integrated high-end AFM/optical microscopy (OM) combinations, all the way to large floor-standing AFM/OM combination instruments for the characterization of 300 mm wafers in a clean room environment.

The company's core technology includes extremely compact AFM/SPM subunits which can be integrated easily with other analytical instruments such as optical microscopes, Raman microscopes or micro-hardness testers.

"Many of the AFM/SPM market segments and applications overlap with those of our X-ray diffraction (XRD) business, making the S.I.S. products an excellent addition for our established worldwide XRD sales force," said Dr. Frank Burgaezy, executive VP of Bruker AXS. "This clear marketing and distribution synergy is expected to be a major driver for the growth of our new Bruker AFM/SPM product line."

Demand of Cardio imaging equipment grows

Cardiovascular monitoring systems are increasingly in demand in Europe, according to global consulting firm Frost & Sullivan (F&S; London). The need for sophisticated, but user-friendly equipment at affordable rates will offer market participants considerable growth opportunities in this sector.

New analysis from F&S, European Diagnostic Cardiovascular Monitoring Equipment Markets, finds that the market totaled revenues of $350 million in 2007 and estimates this to reach $491.3 million in 2014.

"Lifestyle changes and an aging population underpin the increasing incidence of cardiovascular-related illnesses," says F&S research analyst Gideon Praveen Kumar. "These trends contribute to an increased need for diagnostic cardiovascular monitoring equipment market in Europe."

The report says cardiovascular diseases are one of the leading causes of premature death. In Europe alone, about $160 billion is being spent annually on the diagnosis, treatment and rehabilitation of patients with cardiovascular diseases.

Furthermore, statistics have revealed that one in five teenagers suffers from the early signs of heart disease. Under such circumstances, says Frost & Sullivan, diagnostic cardiac monitoring systems are finding wider application in hospitals and cardiac rehabilitation centers to enable effective diagnosis and therapy.

The report notes that ECG is a well-established procedure, but there have not been significant technological breakthroughs in recent years and the market continues to persist with old technologies. This situation has been exacerbated by the lack of funds for the research and development of innovative technologies. In addition, the focus on treatment, rather than monitoring modalities, is threatening to impede market momentum.

"Larger participants have always had the upper hand because of their reputation and the superior brand awareness that they have been able to create," notes Kumar. "This is threatening the survival of smaller competitors."

Despite intense competition, he says growth opportunities exist for companies that form strategic alliances to meet evolving end-user demands. Market expansion will be sustained by technological enhancements that promote greater user friendliness and improve networking and communication capabilities, while supporting cost efficiencies.

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