A Medical Device Daily
Positron (Houston) reported that it has received approval from Health Canada to use its mPower positron emission technology (PET) scanner in oncology and cardiology clinical trials in that country. Positron said it is developing a broad range of applications and upgrades to its mPower line and “will be rapidly expanding the approved uses of its mPower product in Canada.“
Positron said it is positioning itself to take advantage of the Health Canada approval by offering its mPower product to Canadian healthcare providers as a more cost-effective solution to the more traditionally expensive PET and PET/CT products now available in the marketplace.
“We believed for a long time that the Canadian market would be ideal for widespread use of PET scanning since many studies have shown to reduce overall healthcare expenditures to the government payers while improving patient outcomes,“ said Joe Oliverio, president of Positron.
Positron manufactures positron emission tomography technology under the trade name Posicam. Posicam systems incorporate proprietary software and technology for the diagnosis and treatment of patients in the areas of cardiology, oncology and neurology.
MedMira gets HIV test order from UAE
MedMira (Halifax, Nova Scotia), a provider of rapid diagnostic solutions, said it has received an order for 10,000 MiraWell Rapid HIV Tests from its Middle East distributor, Spree Trading (Dubai) , a member of Shawwa Group International (Cairo, Egypt).
The tests are destined for the Dubai, United Arab Emirates (UAE), market, where they will be sold to immigration services, hospitals and other healthcare facilities providing rapid HIV testing. The company said MiraWell HIV is the fastest flow-through rapid HIV test in the world, providing results “instantly.“
“We believe the UAE market and the Middle East region generally hold a great deal of potential for the sale of [our] products,“ said Stephen Sham, chairman and CEO of MedMira.
MedMira completed the registration process for the tests with the UAE Ministry of Health last year. It said Spree will pursue further product evaluations, tender opportunities and new sales channels for the company's products.
MedMira said new market opportunities for other MedMira products include an over-the-counter (OTC) rapid HIV test and rapid test for HIV/hepatitis C co-infections.
Sham said, “The sophisticated healthcare system in the UAE will enable MedMira to expand our product offering in the region to include OTC tests and other, more advanced rapid diagnostic solutions.“
Chembio test recommended in Kenya
Chembio Diagnostics (Medford, New York) reported that its HIV 1/2 STAT-PAK and HIV 1/2 STAT-PAK Dipstick tests have been recommended for use in Kenya.
Both tests were evaluated by the National AIDS/STD Control Programme of the Kenyan Ministry of Health and met their sensitivity and specificity requirements. The approval allows Chembio to begin selling its products in the country.
Kenya's population of 34 million has an estimated 1.2 million people infected with HIV. Under the U.S. administration's $15 billion Emergency Plan for AIDS Relief, the U.S. government plans to provide Kenya with $208 million in 2006 to support Kenya's fight against HIV/AIDS. This will include a significant scale-up of rapid testing programs.
Chembio has also appointed SAI Pharmaceuticals (Nairovi, Kenya) to distribute its rapid HIV tests in Kenya. Kenya is one of 50 countries worldwide that is part of the Clinton HIV/AIDS Initiative Procurement Consortium, and Chembio is one of four recommended global rapid HIV test suppliers under the Clinton HIV/AIDS Initiative. The company also manufactures additional rapid tests that it has developed for other deadly diseases, including human and veterinary tuberculosis and Chagas disease.
Agendia, GeneCare in distribution pact
Agendia (Amsterdam, the Netherlands) and GeneCare of South Africa reported reaching an agreement for distribution of Agendia's MammaPrint and CupPrint products in South Africa.
MammaPrint uses a 70-gene profile to classify breast cancer patients as “low“ or “high“ risk of developing distant metastasis in a 10-year period. MammaPrint therefore offers additional information to oncologists and patients concerning the subsequent treatment plan.
CupPrint test is intended for cancer of unknown primary patients. For these cases finding the primary tumor and therefore providing most appropriate treatment is difficult by conventional techniques, according to Agendia. In contrast, CupPrint identifies the primary tumor which aids in finding the best treatment with the objective of increasing life expectancy and reducing chemotherapy's side effects.
GeneCare offers diagnostic service based on the application of genetic tests with special focus in early detection and disease prevention. Agendia is developing gene expression analysis-based diagnostics.
Aussie ortho firm signs U.S. distributor
Portland Orthopaedics (Sydney, Australia) said it has signed an agreement with Plus Orthopaedics USA to serve as exclusive U.S. distributor of Portland's suite of orthopedic joint products.
Plus Orthopaedics USA is a subsidiary of Swiss-based Plus Orthopaedics AG , which bills itself as the sixth-largest joint implant company with annual revenue of more than $700 million.
Over a contracted minimum three-year period covered by the agreement, Plus USA will distribute Portland's line of products, including the DTC revision hip, the M-COR primary hip, the Asian hip series and the Equator Plus Cup.
Portland said it believed the contract would accelerate its penetration of the U.S. market by up to three years.
“Plus is committed to expanding its U.S. orthopedic business and positions itself as a high-quality supplier of cutting-edge orthopedic products,“ said David Sekel, CEO of Portland Orthopaedics. He said Plus's support of his company's products “is a new opportunity for immediate and substantial market penetration in the U.S. and commercial exposure on a global scale.“
Distribution of Portland's DTC Revision Hip will begin on April 1, with Portland saying it expected Plus USA to place its first orders soon for Portland's soon-to-be-released M-COR and Equator Plus systems.
Plus USA will distribute all of Portland's products through its 29 locations across the U.S.