Diagnostics & Imaging Week European Editor and Staff Reports

In the increasingly crowded competition for in vitro diagnostics, bioMérieux (Marcy l'Etoile, France) is fighting hard to hold its place as the world's seventh-ranked supplier against muscular competition such as market leader Roche Diagnostics (Basel, Switzerland/Indianapolis) or the new market entrant, Siemens Healthcare Diagnostics (Tarrytown, New York), based on Siemens' acquisition of the former Bayer (Leverkusen, Germany) diagnostics unit, which took less than a year to acquire enough companies to rank second in sales.

Seven new product launches by bioMérieux this year and two more acquisitions kept sales better than even, with 1.9% growth in the first half of the year at €528.2 million ($760 million).

The acquisition of AB Biodisk (Stockholm, Sweden) beefed up bioMérieux's capabilities across the board for research, product development and manufacturing, as well as what the company called "very profitable" sales of €13 million ($18.7 million).

With the more recent $60 million acquisition of AviaraDx (San Diego) earlier this month, bioMérieux doubled down its bet on a strategy it calls "theranostics," in honor of the long-term vision of Dr. Christophe Mérieux for personalized, predictive medicine linking diagnostics with therapies.

Also called "tailored therapy" and "translational medicine" by the pharmaceutical industry, Mérieux's disruptive vision is beginning to play out in the marketplace, with bedside tests becoming linked as companions for drug therapies to measure their efficacy.

Taking on AviaraDx does not add to bioMérieux's muscle, nor boost its market position — in fact, the company is expected to produce an $8 million loss this year for its new owners on what are described as "limited sales."

But with a unique molecular technology for classifying tumor tissue in massive market segments for metastatic cancer where the origins of the cancer are unknown, and for breast cancer, AviaraDx does bring to life the theranostics vision and the first go-to-market products.

AviaraDx, with its 19 employees will be reorganized as an independent legal entity called bioTheranostics.

In the new company, AviaraDx will join with bioMérieux's 12-person theranostics business unit created earlier this year in Cambridge, Massachusetts.

Stéphane Bancel, CEO of bioMérieux, said the new bioTheranostics "should have limited sales until 2012 and break even around that year," consistent with the company's long-term strategic goals and financial objectives.

Richard Ding, who as vice president of the theranostics group moved up to become CEO for the new bioTheranostics unit, told D&IW that there already are cancer therapies that cannot be applied without companion diagnostics and he expects these linked tests will become a requirement from the FDA.

"But it will take time for this market to materialize," he added.

Traders on the Euronext exchange in Paris greeted the company's news with an 8.6% loss on the stock across three successive sessions.

Placement draws $8.3M to CMA

The CMA Microdialysis (Solna, Sweden) subsidiary of Skanditek (Stockholm, Sweden) has completed a private placement of new shares amounting to SEK 56 million (about $8.3 million) from Investor Growth Capital, a subsidiary of Investor AB.

Within a period of three years, CMA's board of directors will have an opportunity to arrange an additional private placement in an amount of SEK 14 million.

CMA will hold an extraordinary general meeting on Oct. 16.

Prior to the private placement, Skanditek's shareholding in CMA amounts to 77.95%. Following implementation of the private placement, Skanditek's shareholding in CMA will be reduced to 49.93% and CMA will switch from being a Skanditek subsidiary to an associated company.

CMA is a pioneer within organ diagnostics and tissue chemistry monitoring. The company's medical devices are used in intensive care across the globe to monitor biochemical processes in organs such as the brain, liver and abdomen. The unique technology provides opportunities to detect changes in organ chemistry, thereby predicting the onset of complications and disease processes.

The company was founded in 1984.

Skanditek is an industrial holding company with investments in Swedish companies. The portfolio comprises nine investments in the electronics, biomedical technology and services sectors.

CMA was awarded a large grant from VINNOVA, the Swedish governmental agency for innovation systems, in 2007. The grant has enabled the development of a new technical platform offering the opportunity for real-time monitoring of blood glucose and other metabolic markers.

"The aim of the growth capital is to accelerate our efforts to develop a new real-time system for monitoring metabolic markers, including blood glucose. Our vision is to offer real-time solutions that can streamline the many manual routines of modern intensive care by delivering quicker and more accurate clinical decisions," said CMA President/CEO Philip Siberg.

The aim of the growth capital is to accelerate CMA's growth plans and to prepare for a future international roll-out of the company's new technology platform.

As a part of the intensified growth agenda, CMA will simultaneously invest SEK 27.5 million ($4.1 million) in the affiliate company, Dipylon Medical.

mtm launches CINtec Cytology

mtm laboratories (Heidelberg, Germany), a global cancer diagnostics company, reported the European launch of its CINtec Cytology kit with extended claims for the diagnosis of cervical cancer.

The clinical claims are derived from the outcome of a recent pan-European pivotal study involving pathologists and cytotechnologists from France, England, Spain, Italy and Germany.

The multi-center trial was conducted to determine the sensitivity and specificity for the detection of underlying high grade disease for women with ASC-US (equivocal) or Low Grade (mild abnormality) cytology results to High Risk HPV (HR-HPV) testing.

The company said the overall sensitivity for the detection of CIN2 and higher grade disease exceeded 92%, which was essentially the same as that of HR-HPV testing. However, the specificity of CINtec Cytology was 67% to 100% higher than that of HR-HPV testing.

Ruediger Ridder, chief scientific officer of mtm laboratories, said, "Equivocal or mild results such as those examined in the study are clinically relevant, since a portion of these actually harbor high-grade disease, the immediate precursor to cervical cancer, and as such cannot be ignored."

He added, "However, it is costly and inefficient to treat or manage all of the cases based on the initial cytology finding, which is why a more accurate biomarker-based test such as CINtec Cytology is needed to pinpoint those cases where there is high grade disease."

Company CEO Bob Silverman said, "Approximately 6% to 8% of Pap test results will be equivocal or mildly abnormal. While the majority of these diagnoses are benign, 10% to 15% of these cases will harbor high-grade disease, creating a clinical dilemma for clinicians. The results of this trial demonstrate that CINtec Cytology can more accurately identify those women with high-grade disease than managing these cases with HR-HPV testing.

Silverman added, "This is a major advance in cervical cancer screening, and for the women participating in screening programs."

The CINtec Cytology Kit is an immuno-cytochemistry assay for the qualitative detection of the p16INK4a antigen on cervical cytology preparations. It is intended to be used as an aid in the identification of women with underlying high-grade cervical intraepithelial lesions in the sub-group of patients with a Pap cytology result of ASC-US (atypical squamous cells of undetermined significance) or LSIL (low-grade intraepithelial lesion).

Varian systems set for Indonesia

Varian Medical Systems (Palo Alto, California) reported the signing of a memorandum of understanding (MOA) with Indonesia's first private cancer hospital, Mochtar Riady Comprehensive Cancer Center (MRCCC; Jakarta, Indonesia), under which cancer patients in that country will gain access to advanced radiotherapy treatments.

Siloam Hospitals Group, operator of MRCCC, and Varian have agreed to pursue a collaborative relationship to explore opportunities for developing innovative solutions for delivering the latest cancer treatments in Indonesia.

The Building of Hope, which incorporates the MRCCC, is a new 29-story, 210-bed specialist hospital in central Jakarta. It is expected to be a major center of excellence for cancer in the Southeast Asia region when it becomes operational in December 2009.

Dr. Mochtar Riady said, "It is wonderful for the Mochtar Riady Comprehensive Cancer Center to partner with Varian Medical Systems, which is the world's leading manufacturer of medical devices and software for treating cancer and other medical conditions with radiotherapy, radiosurgery, proton therapy and brachytherapy. We are very enthusiastic about working with Varian to bring such leading technologies and therapies to Indonesia in our fight against cancer."

The MRCCC, which plans to acquire two Varian Clinac iX linear accelerators equipped with the country's first On-Board Imager devices that enable targeted image-guided radiotherapy (IGRT), will be the most fully equipped cancer center in Indonesia when it opens.

IGRT is a precise form of treatment that utilizes multiple imaging and motion management techniques to target tumors precisely and avoid damaging surrounding healthy tissue. Riady said, "The vision for the MRCCC is to provide an international standard private cancer and specialist hospital in Central Jakarta, using state-of-the-art equipment that incorporates the latest generation of smart IT systems."

"This splendid new facility will be a landmark center and will provide Indonesia cancer patients with much-needed access to the latest and most effective forms of radiotherapy treatment," said Tim Guertin, president/CEO of Varian Medical Systems. "Varian is delighted to be working with Siloam Hospitals Group to make this very significant project a reality."

Nearly 800,000 people in Indonesia are afflicted with cancer each year, but advanced cancer facilities are rare in the country.

Siloam Hospitals Group is a division of PT Lippo Karawaci, Indonesia's largest broad-based property company. Siloam is that country's leading private hospital group, currently operating four international-standard hospitals and one specialist clinic across Jakarta and Surabaya.

Siloam Hospitals is investing $500 million over the next five to 10 years to build 10 new hospitals in Indonesia.

Varian develops devices and software for treating cancer and other medical conditions with radiotherapy, radiosurgery, proton therapy, and brachytherapy. It supplies informatics software for managing comprehensive cancer clinics, radiotherapy centers and medical oncology practices. It is a major supplier of tubes and digital detectors for X-ray imaging in medical, scientific and industrial applications.

Varian operates 60 sales and support offices around the world.

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