A Diagnostics & Imaging Week
MedMira (Halifax, Nova Scotia), a leading provider of rapid flow-through diagnostic products, said it has entered into a strategic partnership with Tianhe Pharmaceutical Co. Ltd. (Guilin, China), which it described as “one of the most successful pharmaceutical companies in China.”
The companies have formed a joint venture that MedMira said would open new markets in China and other Asian markets for its current and future rapid diagnostic products in China, including over-the-counter sales.
MedMira said the joint venture will include some production of tests in China, while the majority of research and development and manufacturing will remain in Nova Scotia at the company’s global headquarters. The work done in China, it said, will allow “faster approval of new products in China and speedier entrance into other Asian markets.”
Stephen Sham, MedMira’s chairman and CEO, said the company’s entry into China’s rapid HIV testing market “has progressed steadily over the past 24 months, and to date, we have been very successful in establishing countrywide recognition for our rapid HIV tests.”
He said that recognition has led to the joint venture opportunity with Tianhe, which he said “will help MedMira to bring our rapid diagnostic solutions closer to the end-users while improving our competitive position in one of the world’s largest markets.”
“The rapid growth of China’s economy and [its] recent entry into the World Trade Organization make this region the biggest future market for high-quality in vitro diagnostics (IVD) products,” said Guifa Tan, chairman and CEO of Tianhe Pharmaceutical. “We are ... pleased to be partnering with MedMira, the global leader of rapid flow-through diagnostic technology.”
He added: “Together we will be able to fully utilize our resources to increase market share in all Asian countries, particularly in China.”
Sham said Tianhe has more than 50 years of medical and pharmaceutical experience in the direct consumer market in China. “They will be very valuable in helping us launch our next generation of rapid tests, including the newest rapid HIV test for whole blood, serum and plasma, into China’s consumer market in the very near future.”
MedMira’s tests provide diagnosis in just three minutes for the detection of human antibodies in human serum, plasma or whole blood for diseases such as HIV and hepatitis C. Its Reveal G2 and MiraWell rapid HIV tests are used in clinical laboratories, hospitals and clinics, while MiraCare Rapid HIV Antibody Test is an OTC product available in pharmacies throughout the Hong Kong and Macao special administrative regions of China.
In addition to its headquarters and manufacturing facilities in Halifax, the company has a representative office in Beijing.
autoflexII gets Korean medical device registration
Bruker Daltonics (Billerica, Massachusetts) reported obtaining registration of its autoflex II MALDI-TOF mass spectrometers as Class I medical devices with the Korea Food and Drug Administration (Seoul, South Korea).
While Bruker noted that MALDI-TOF mass spectrometry is increasingly being applied to the areas of clinical proteomics, functional genomics and biomarker discovery as a clinical research tool, it said that, with recent advances, usage of MALDI-TOF in in vitro diagnostics (IVD) applications has become “very promising.”
The company said it has taken the step of registering its autoflex II systems as medical devices in South Korea in order to facilitate regulatory approval of mass-spectrometry based IVD methods by its Korean customers.
Bruker Daltonics has developed the ClinProt solution for peptide and protein biomarker profiling, discovery, identification and validation from body fluids or tissue samples. It said the solution offers a combination of cost-effective, scalable sample preparation using magnetic bead arrays, high-performance MALDI-TOF and TOF/TOF detection, and advanced analysis and visualization software.
The company’s autoflex II mass spectrometers are a key part of the ClinProt solution, offering throughput up to thousands of samples per day.
Bruker Daltonics said the autoflex II product is now being used in Korea by GeneMatrix, an emerging molecular diagnostics company, for molecular diagnostics applications, including the diagnosis of Lamivudine-resistant hepatitis B virus, hepatitis C virus genotyping and human papilloma virus genotyping, based on GeneMatrix’ Rstriction Fragment Mass Polymorphism technology.
GeneMatrix testing services already are in use by a number of Korean medical centers and university hospitals.
Bruker Daltonics is a unit of Bruker BioSciences.
Law Centres, DNA Bioscience in accord
DNA Bioscience (London), a DNA testing company, has reported a new partnership with the Law Centres Federation (LCF). DNA Bioscience will become the recommended supplier of DNA testing services to the 57 Law Centre locations across the UK.
The company also is launching a new Continuous Professional Development module, accredited by the Law Society, to educate lawyers about how DNA testing can help their cases. That training will be held at Law Centres across the country.
Avi Lasarow, managing director of DNA Bioscience, said, “Law Centres pride themselves on being the first port of call for the poor or socially excluded in need of advice and access to services. It’s a reality that DNA testing is required by many of these people, for reasons as diverse as immigration and paternity. We take our social responsibility very seriously and this partnership with the LCF is designed to allow us to reach out and help the most disadvantaged members of society.”
DNA Bioscience was established in December 2002. It is focused on providing reliable and confidential global DNA products, including “peace of mind” testing for consumers and legal testing for courts and legal disputes. Its services include paternity/maternity testing, sibling verification, DNA storage and profiling.