Tm Bioscience Corporation, a leader in the commercial genetic testing market, has announced results from clinical testing relating to high discriminating ability of the ID-Tag RVP with regards to the highly pathogenic H5 subtype of the influenza A virus. This virus is the focus of the current pandemic threat being monitored through the World Health Organization.
The primary aim of the European arm of the multi-national clinical study sponsored by Tm was to collect data on viruses that are underrepresented in the general population, including the H5 subtype of Influenza A. This was achieved by including archived samples in the study, which had an overall recruitment of more than 1000 unique patient specimens. Results have confirmed the ability of the ID-Tag RVP to detect the bird flu virus in all positive clinical samples tested (0 per cent false negative rate for H5). Additionally, the majority of patient samples tested by the ID-Tag RVP across both the European and North American arms of the clinical trial were probed for Influenza A-H5. There were no false positive results observed in any of these samples.
"This seminal study definitively establishes the ID-Tag RVP as a rule-in rule-out test in the area of respiratory virus testing," said Dr. Richard Janeczko, chief scientific officer of Tm Bioscience. "In addition, our collaboration with one of the world's leading centres for research on avian influenza has confirmed that this test can accurately detect the H5 subtype of Influenza A in samples originally collected from patients infected with mutated strains that were responsible for human outbreaks in Vietnam, Hong Kong and Indonesia."
"The productive collaborations that we've had with world renowned virology laboratories have helped Tm establish a strong footprint in the area of infectious disease testing, which represents the majority of the market for molecular diagnostics. These laboratories are also part of the integrated network of health care professionals that are crucial in managing epidemics like the recent SARS crisis experienced in many countries," said Mr. Greg Hines, president and CEO of Tm Bioscience. "Our investment in this clinical trial program and related regulatory submissions for the ID-Tag RVP product has set the stage for this test to become a worldwide standard."
The ID-Tag RVP is a proprietary test that, in a single patient sample, simultaneously probes up to 20 distinct viral sequences that represent more than 95 per cent of all circulating respiratory viruses. Viruses targeted by the ID-Tag RVP include those that are important for patient management in addition to those monitored by public health authorities and pandemic surveillance programs, such as SARS and influenza A H5 (the subtype associated with avian influenza -bird flu).
The ID-Tag RVP has been designed in such a way to enable, through a single test on a patient sample, discrimination of the H5 subtype of influenza A from the subtypes generally seen in the human population (H1 and H3). It also discriminates influenza A from a panel of respiratory viruses, including those with similar clinical presentations. The fact that the ID-Tag RVP can provide a definitive result in six hours will allow public health authorities to rapidly implement infection control measures in the event of a highly contagious agent being identified.
The ID-Tag RVP from Tm Bioscience is a reliable and cost-effective test designed to play a key role in patient management, infection control and in countering the pandemic threat of respiratory diseases, all with results in less than six hours.
In addition to CE marking in Europe, the company is focused on gaining regulatory clearance from the FDA for the ID-Tag RVP as an in vitro device (IVD) in the US and is also working towards Health Canada approval. The CE marked IVD product probes for 20 viral sequences and Tm is seeking a license for an equivalent IVD product in Canada. In the US, the IVD application is for a product which excludes the SARS sequence.
Most recently, the company has signed distribution agreements for ID-Tag RVP in the Netherlands, Scandinavia, Greece and Turkey. Tm anticipates securing additional distribution agreements for the product with the goal of making the test available globally.