Diagnostics & Imaging Week and Staff Reports

Guerbet (Villepinte, France), a provider of contrast agents for medical imaging, said it is entering the expanding market for nuclear medicine securing European distribution rights for products from Draxis Specialty Pharmaceuticals (Kirkland, Quebec).

"This constitutes a first step for Guerbet," said Philippe Decazes, chairman of the executive committee for the company, adding that the partnership provide a promising driver for growth.

Four Draximage products – MDP, Sestamibi, DTPA, MAA and I-131 – will become available immediately through Guerbet's European distribution network and Decazes said Guerbet holds a preferential right to distribute any new Draximage products.

Guerbet generated 80% of its annual sales of €321 million ($415 million) in Europe in 2008 and estimates that it holds a 25% share of the market.

Sales grew 5% from 2007, with Germany reporting particularly robust growth.

Nuclear medicine explores the function and processes of organs with the injection of radioactive agents and is increasingly used for the diagnosis of cancers and cardiovascular disorders.

The growing trend in radiology for studying complex disease processes are combinations of nuclear agents with scans for magnetic resonance imaging (MRI) and computed tomography (CT).

While expanding into the developing market for nuclear agents, Guerbet also announced developments reinforcing it product line for contract agents used in traditional MRI, X-ray and CT imaging.

Sales of Guerbet's flagship MRI product, Dotarem, grew 29% in volume and 24% in value to become the leading European product in this market.

The company opened four new production facilities in 2008, and is a leading partner in the Franco-German research program, Iseult, that is focused on new contrast products for molecular imaging using high field magnetic resonance neuroimaging technologies for early diagnosis and therapeutic monitoring of Alzheimer's disease, cerebrovascular accidents and brain tumors.

With a budget of €137 million, participants in the consortium of manufacturing groups and public research laboratories include Siemens (Erlangen, Germany), Bruker Biospin (Rheinstetten, Germany), a subsidiary of Brucker (Billerica, Massachusetts), CEA (Commissariat à l'Énergie Atomique, Grenoble, France) and the University of Freiburg (Germany).

Guerbet received €34 million as part of a grant for the Iseult program from the French innovation agency, OSEO, that the company says will fund provides eight years of funding for developing MRI contrast agents.

ThyroChek now available in EU

Screening Devices Canada (Saint John, New Brunswick) reported the availability of ThyroChek, its rapid test for elevated TSH, the first clinical indicator of hypothyroidism to countries in the European Union.

Until now, the test has only been offered in the U.S. as an FDA-regulated, CLIA-waived test for adults to some 200,000 physician office labs.

With receipt of the CE mark, both adult and neonatal ThyroChek tests now are available for sale worldwide, the company said.

The move to overseas markets will build the thyroid health market, according to Sharon Cunningham, president of Screening Devices Canada. "Europeans know their thyroid gland. Food, such as bread in Russia, is marked indicating that the nutrients contained in the loaf support thyroid health."

She added that ThyroChek may also be available as a home test in Europe, so that consumers can assess their own thyroid health. "This is important," Cunningham said, "especially to women planning pregnancies, to seniors concerned about vagaries of aging and to residents that have environmental concerns such as nuclear waste storage that may reflect in thyroid health."

ThyroChek NeoNatal has never been available in the U.S., since testing newborns for TSH elevation, an indication of congenital hypothyroidism, is performed routinely in every hospital.

Screening Devices Canada said this is not the case in some countries of the EU, adding that most countries of South America, Africa and Asia also do not have a testing program. Cunningham said the CE-mark approval "will enhance neonatal testing opportunities for this disease in iodine-deprived areas of the world."

Arobella gets CE mark for Wound Therapy

Arobella Medical (Minnetonka, Minnesota) reported receipt of the CE mark for its Qoustic Wound Therapy System for ultrasound-aided wound care.

The system uses what the company terms "a unique, dome-shaped curette tip to apply low-frequency, cavitational ultrasound to wounds."

It said the combination of physical design and ultrasonic energy "gently removes dead and diseased tissue cells, kills harmful bacteria and biofilm, and leaves healthy and pre-healing granulation tissue intact."

The device is FDA-cleared and already on sale in the U.S.

President/CEO Eliaz Babaev, PhD, said the Qoustic Wound Therapy System "offers cutting-edge ultrasound technology several generations ahead of its competitors. We look forward to bringing this device to the international market."

Arobella Medical specializes in low-frequency ultrasound in wound management therapies. Co-founder Babaev has more than 45 years of experience developing, designing and commercializing medical devices that use ultrasound.

CE mark for TheraScreen kit

Personalized medicine company DxS (Manchester, UK) has received CE-mark certification for the TheraScreen K-RAS Mutation Kit (CE-IVD) for use on Roche's (Basel, Switzerland) LightCycler 480 Instrument II, allowing it to be sold for clinical use in the European Union.

The test helps doctors to identify a patient's K-RAS mutation status and response to anti-EGFR therapies for colorectal cancer. DxS also secured a license to provide Roche's LightCycler Adapt Software v1.1 to be used with the TheraScreen K-RAS Mutation Kits. The software allows automated processing of K-RAS mutation status tests for colorectal cancer patients.

Dr. Stephen Little, CEO of DxS, said, "This is excellent news for our customers. Not only do they have access to the TheraScreen K-RAS Mutation Kit, but they can now use the LightCycler Adapt Software v1.1 for the TheraScreen K-RAS Mutation Kit to help run the assay and interpret results, making our highly-sensitive K-RAS test the most user-friendly option currently available."

LightCycler Adapt Software v1.1 for CE-IVD is a specialized software package for use with the LightCycler 480 Instrument II which provides automated data processing, avoiding manual interpretation and human error.

The software generates data that is compatible with both LIMS (Laboratory Information Management System) and PMS (Patient Management System), and produces the results in a read-only format, ensuring that a patient's results are secure. The software also has a built-in warning system that generates a troubleshooting message if an assay has not been run correctly.

The LightCycler Adapt Software v1.1 for CE-IVD is available for installation in territories where the TheraScreen K-RAS Mutation Kit is available for sale via Roche. These include Europe, Saudi Arabia, South Africa and Australia.

UK sets evidence review on screening

A panel of experts is set to carry out an evidence review to determine whether women under the age of 25 should be routinely screened for cervical cancer, UK Health Minister Ann Keen said recently.

Cervical screening currently starts at age 25 years in England, in line with World Health Organization (Geneva, Switzerland) recommendations and the advice of leading experts in this country including the independent Advisory Committee on Cervical Screening (ACCS).

The Health Minister has asked the ACCS to review the latest available evidence relating to the risks and benefits of cervical screening in women under 25. The review will:

– Consider evidence of the harms and benefits of cervical screening in women aged 20-24 and look at trends in cervical cancer incidence and mortality in women under 25 years in England.

– Consider the likely impact of HPV vaccination on future incidence of cervical cancer and the timescales for any likely effects.

– Assess levels of awareness of cervical cancer and its symptoms especially in younger women 25-34 who are the least likely to take up screening invitations and consider further measures to increase uptake.

– Consider what measures might be taken to improve knowledge and awareness among GPs and practice nurses regarding the appropriate management patients with possible symptoms of cervical cancer.

– Consider whether asymptomatic women under 25 years should have access to cervical screening either as part of a formal program or through informed choice.

The ACCS will consider the latest evidence available, including evidence from the key cancer charities who will be invited to contribute to the review. The board of experts will then recommend whether it is beneficial for women under 25 to be screened.

Keen said, "We are very proud of our cancer screening programs in the NHS, which are internationally recognized as world-class. Cervical screening saves around 4,500 lives every year and we want to ensure that our program remains in the best interests of young women. Experts will review the latest available evidence in this area as well as consider how we can increase awareness of the importance of screening and encourage more women to decide to take up this important service."

The evidence review will be conducted by the ACCS, which is chaired by Professor Henry Kitchener, National Cancer Director Professor Mike Richards and the director of the NHS Cancer Screening Programs, Julietta Patnick.

CE mark for OrSense sensor

OrSense (Nes Ziona, Israel), a developer of monitors for non-invasive measurements of various blood parameters, reported at the 29th International Symposium on Intensive Care and Emergency Medicine (ISICEM) in Brussels, Belgium, that it has received CE-mark approval for its NBM-200MP, a multi-parameter sensor for non-invasive continuous hemoglobin, low signal oximetry and pulse rate measurements.

"This is an important milestone for OrSense in the path for developing and marketing our unique, non-invasive multi-parameter blood monitoring device, which is expected to enhance the quality of treatment and reduce operational costs in hospitals," said CEO Lior Ma'ayan "We will soon initiate sales in various counties in Europe."

The company is holding a symposium at ISICEM that will be chaired by Pierre Singer, MD, head of the intensive care department at Rabin Medical Center (Petah-Tikva, Israel) and Sackler School of Medicine at Tel Aviv University, who will present new data indicating that OrSense's non-invasive continuous monitoring system accurately measures levels of oxygen saturation, hemoglobin and glucose in an intensive care unit.

OrSense noted that hemoglobin (Hb) level, a parameter which indicates hemorrhage or anemia, is a key measurement in hospitals and outpatient wards. "However, current hemoglobin measurements are invasive, time-consuming, labor-intensive and costly," it said.

While non-invasive pulse oximetry has become a standard of care throughout the medical world, the company said it "has been known to provide erroneous oxygen saturation readings in states of low perfusion, low cardiac output and/or low blood flow."

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