A Diagnostics & Imaging Week Staff Report

NorDiag (Bergen, Norway) and Transgenomic (Omaha, Nebraska) reported entering into an exclusive license and supply agreement that the companies said would unite their technologies in the fight against colorectal and pancreatic cancer.

Transgenomic has granted NorDiag exclusive European commercial rights to use its WAVE System and associated consumables to perform molecular diagnostic testing for the detection of colorectal and pancreatic cancer from stool samples. NorDiag will pay a licensing fee and has committed to certain minimum annual purchases.

NorDiag uses the WAVE System in its Genefec test, which can detect mutations associated with early development of gastrointestinal cancers such as colorectal cancer, which is the second most common cause of cancer mortality. Early detection has been shown to "significantly improve" patients' long-term survival prospects, the company said.

Christian Horn, NorDiag CEO, said, "The exclusive European license to Transgenomic's proven technology, which has been adopted in medical centers and research institutions [in] more than 35 countries, will further strengthen NorDiag's position as an emerging European leader in molecular diagnostic testing."

Horn said that following its initial success in the Scandinavian market, NorDiag is preparing to introduce Genefec to additional European markets.

He added that the WAVE System "is an important component in the automation and standardization of Genefec testing."

Transgenomic CEO Collin D'Silva, said NorDiag's sample-preparation methods "are an excellent complement to our high-sensitivity mutation detection technology. We believe this test offers significant benefit to patients, and that the success of the WAVE System in this setting demonstrates its potential application in a variety of related areas."

Transgenomic said that to date, more than 1,000 WAVE systems have been installed in more than 30 countries around the world.

Positron gets China okay for j-v

Positron emission tomography (PET) scanner manufacturer Positron (Houston) said it has received Chinese government approval for a joint venture with Neusoft Medical Systems (Shenyang, China).

The j-v business, known as Neusoft-Positron Medical Systems, was initiated in Shenyang in mid-January. The company will manufacture all of Positron's PET and PET/CT (computed tomography) systems.

Neusoft Medical Systems was founded in 1998, originating from Neusoft Group, the largest software company in China. The company produces a wide range of diagnostic imaging products and has installed thousands of units worldwide.

Positron's president, Joseph Oliverio, said the joint venture "immediately brings a number of key elements to Positron that will position [us] as a leader in the PET industry. The Neusoft relationship adds valuable software and hardware design development capabilities that will enable Positron to deliver state-of-the-art PET and PET/CT devices."

He said the manufacturing savings realized through the new partnership "will dramatically lower our cost of goods, labor rates and component pricing, allowing Positron to be much more efficient and effective in the global marketplace."

Positron's PET systems are sold under the Posicam trade name for the diagnosis and treatment of patients in the areas of cardiology, oncology and neurology.

Chembio cites activity in various markets

Chembio Diagnostics (Medford, New York) reported earlier this month that it had shipped about $540,000 worth of the company's rapid HIV tests to the Ministry of Health in Uganda. The company's HIV 1/2 Stat-Pak test is designated in Uganda as the confirmatory test in all of the national rapid HIV testing protocols.

"The demand for HIV rapid tests is expected to increase in Uganda and other countries in the region as public health officials are encouraging the use of rapid testing devices to identify and diagnose infected individuals," said Chembio President Lawrence Siebert. "Chembio's is the exclusive confirmatory test that is used on those who test positive during initial screening, a number that varies with the prevalence of the disease in the groups tested."

He said that Uganda's demand for rapid HIV tests is expected to exceed several million tests for 2006.

Chembio also said that its HIV 1/2 Stat-Pak, HIV 1/2 Stat-Pak Dipstick and Sure Check HIV tests have been evaluated and recommended for use in Zambia. The company said the evaluation found the performance of Chembio's tests to be comparable and in some respects superior to other commercial tests in standard use in Zambia.

Separately, Chembio said it has received a $1.2 million purchase order for its Chagas Stat-Pak rapid test to supply the National Chagas Program that has been established by Bolivia's Ministry of Health. Chembio's Chagas Stat-Pak will be used to screen children in areas of Bolivia where this parasitic infectious disease is most endemic. Deliveries are to be made through the first seven months of 2006.

The company said an estimated 25% of the Latin American population, or nearly 100 million people in 21 countries, is at risk of Chaga infection. Chagas also is becoming a growing concern for the U.S. and Europe as immigration increases from these endemic areas.

Testing set for AlzheimAlert in UK

Nymox Pharmaceutical (Hasbrouck Heights, New Jer- sey) has entered into an agreement with Lab21 Ltd. (Cambridge, UK) for Lab21 to provide testing of Nymox's AlzheimAlert product in the UK.

AlzheimAlert provides physicians with a tool for the diagnosis of Alzheimer's disease (AD) by measuring levels of a brain protein in urine samples.

Lab21 provides clinical testing services for the pharmaceutical industry and healthcare providers in the UK, with particular emphasis on antiviral drug discovery plus a portfolio of molecular diagnostics, viral characterisation, pharmacogenetic tests and patient profiling.

"This agreement will give physicians in the UK access to our AlzheimAlert testing technology," said Brian Doyle, Nymox's senior manager for worldwide sales and marketing. "Lab21 . . . is an excellent partner for launching AlzheimAlert in the UK."

With this agreement, the UK joins Spain, Greece, Italy and the Czech Republic as EU countries in which the AlzheimAlert product is now available.

The AlzheimAlert test measurs the level of a brain protein called neural thread protein found in higher amounts in the urine of patients suffering from Alzheimer's disease.

ComfortScan under review in China

DOBI Medical International (Mahwah, New Jersey) said clinical testing of its ComfortScan system is under way in several international locations. Furthest along in that effort, the company said, is China, where patient recruitment and data collection for a clinical study of its ComfortScan system in Beijing was completed recently.

Initial documentation of the study has been submitted for review by the Chinese State Food and Drug Administration (SFDA), and the company said it expects to meet with the agency in the near future to discuss questions it may have regarding the ComfortScan system and the results of the study.

After a complete review of the relevant data, the SFDA will determine whether to grant approval for the sale of ComfortScan systems in China.

The ComfortScan system is a non-invasive and non-ionizing, optical imaging system designed to assist physicians in the identification and management of breast cancer as an adjunct to screening mammography through the identification of abnormal vascularization associated with tumors.

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