A Medical Device Daily

Luminex (Austin, Texas) said it has received clearance from Health Canada for its xTAG Respiratory Viral Panel (RVP).

The company calls xTAG RVP "a unique, groundbreaking test that, from one patient sample, simultaneously detects the 18 respiratory viruses and subtypes that are responsible for the majority of respiratory viral infections."

Luminex noted that as many as 80% of respiratory infections are caused by viruses, "yet these viruses are rarely tested for because the appropriate tests do not exist, are not specific or accurate enough, or are too slow to positively impact patient treatment."

The 18 viruses and subtypes that can be detected by xTAG RVP include influenza; rhinovirus, which causes the common cold; and metapneumovirus, a new virus that Luminex said is a growing cause of respiratory infection in small children.

"The test has the potential to improve patient care, reduce healthcare costs and prevent the inappropriate antibiotic use that has contributed to the creation of 'superbugs,'" the company said.

"With this insight, we can track and contain virus outbreaks more effectively. This test has great public health value," said Dr. Julie Fox, of Provincial Laboratory for Public Health (Calgary, Alberta).

"xTAG RVP is a significant advance over traditional virus testing and has the potential to change the way respiratory viruses are diagnosed and monitored in Canada," said Dr. James Mahony, director of the Regional Virology Laboratory at St. Joseph's Healthcare and professor of pathology & molecular medicine at McMaster University (Hamilton Ontario), who was instrumental in the development of xTAG RVP.

xTAG RVP was created by Luminex Molecular Diagnostics (LMD; Toronto), in partnership with a team of leading virologists and infectious disease specialists, including Mahony.

LMD, formerly named Tm Bioscience, was acquired by Luminex in March 2007.

Costa Rica facility gets ISO, FDA okays

ATEK Medical (Grand Rapids, Michigan), a division of ATEK Companies, said that its new 33,000-square-foot medical device manufacturing facility in Heredia, Costa Rica is ISO-13485:2003 certified and is also registered with the FDA.

The ISO 13485:2003 certification is based on an inspection earlier this year by TUV America.

"We have always been committed to excellence," said Chris Oleksy, president, ATEK Medical. "The ISO certification and FDA registration demonstrates that our focus — whether in Grand Rapids or Heredia — remains on quality, performance and continuous monitoring of our business operations."

Located nine miles north of the Costa Rican capitol of San José in a Free Trade Zone, ATEK Medical's facility specializes in Class II single-use and electro-disposable device, and Class III implantable device manufacturing.

All aspects of the facility were designed for compliance to ISO-13485 standards for medical device production. The facility opened in October 2007 and will soon be at full operating capacity, the company said.

Jorge Vargas, Costa Rica general manager for ATEK, said, "From the initial phases, we worked very hard to prepare our facility for the ISO auditing process. The certification was a critical milestone for our operations. We are proud that we were able to gain our ISO certification in a short period of time — it is a testament to our commitment and expertise."

ATEK Medical is a total solutions partner serving the medical, disposable, electro-mechanical and implantable device markets. The company provides services ranging from product design and launch to distribution and post-production fulfillment.

Chinese firm buys HPV test system

China Medical Technologies (Beijing) said last week that it bought the rights to a human papillomavirus (HPV) detection system from Molecular Diagnostic Technologies for $345 million.

The company said it would pay for the HPV-DNA Biosensor Chip and Surface Plasmon Resonance based Analysis System over the next year. It said it expects the deal to close in December or January.

The DNA chip is able to genetically identify 24 common strains of HPV, including strains that can cause cervical cancer and others that cause genital warts.

The Molecular Diagnostic Technologies system analyzes the data on the DNA chip, and is used in molecular diagnostics to identify proteins and ailments including infectious diseases, cancers and heart and immune system disorders.

China Medical Technologies said about 50 million HPV-related gynecological tests are done in China every year, and about 120 million women should receive cervical cancer tests. It said that revenue from the HPV-DNA Biosensor Chip could reach $700 million annually.

GE, Bangladesh firm in collaboration

Grameen Health (Dhaka, Bangladesh) and GE Healthcare (Chalfont St. Giles, UK) said they will work together to identify "sustainable models" for healthcare delivery in Bangladesh and ultimately in other developing countries.

The companies said they will jointly evaluate ways to improve Grameen Health's existing healthcare delivery systems and primary care clinics in rural Bangladesh. They intend to identify appropriate business models that could be replicated in other countries.

GE said the challenge is to address the needs of some 4 billion people around the world whose annual income is less than $3,000.

The company said it would test delivery of ultrasound capability in rural clinics for early detection of abnormalities, especially in maternal care.

GE says it has taken steps to enhance accessibility of ultrasound through training and education, starting with a pilot program with U.S. medical students.

The partnership will emphasize primary healthcare and disease prevention, as well as evaluating product, training, workflow and other capabilities that would be needed for full deployment of ultrasound capability in rural areas.

In addition to its partnership with GE, Grameen is partnering with Pfizer (New York) and the Mayo Clinic (Rochester, Minnesota), to improve the training, efficiency, and retention of staff at existing Grameen Health Kalyan clinics.

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