Tm Bioscience (Toronto:
TMC), a leader in the commercial genetic testing market, today announced
that to date more than 25 leading healthcare institutions and laboratories
across North America, Europe and Asia have entered its Early Access Program
to assess the ID-Tag(TM) Respiratory Viral Panel (RVP), a unique test that
has the potential to play a key role both in the management of patients
exhibiting respiratory distress in clinical settings and in countering the
pandemic threat of respiratory viruses.
"Healthcare institutions around the world will benefit significantly
from a test that can rapidly and reliably identify patients infected with
respiratory viruses. Our panel will be evaluated in a variety of
prestigious high-volume healthcare facilities that will provide us with
important feedback, ensuring our test fully addresses their needs and is
marketed effectively," said Mr. Greg Hines, President and CEO of Tm
Bioscience. "These institutions will also be able to gain experience with
the ID-Tag RVP, allowing them to implement the test rapidly once it
completes the regulatory approval process."
Michael Mihalov, MD, Chair of Pathology and Director of the Diagnostic
Molecular Pathology Lab at Resurrection Medical Center, one of the
institutions participating in the Early Access Program, said he expects the
ID-Tag(TM) RVP to prove advantageous in testing for various respiratory
viruses quickly, economically and accurately. "Our lab has had great
success with Tm Bioscience products, and we are anxious to evaluate their
respiratory panel. Current respiratory viral testing is time-consuming and
inconvenient for a high-volume hospital serving thousands of patients in a
large metropolitan area. ID-Tag RVP will help us identify respiratory
viruses more rapidly and undertake appropriate intervention, whether that
is treatment or isolation," Mihalov said.
Early access partners include community hospitals, pediatric hospitals,
reference laboratories and public health labs such as the Alberta
Provincial Lab for Public Health (ProvLab) in Calgary, AB, a leader in the
area of molecular testing for respiratory viruses.
The Tm Bioscience ID-Tag(TM) Respiratory Viral Panel (RVP)
Tm Bioscience's ID-Tag RVP is a proprietary, comprehensive test for the
detection of 20 of the most common strains and subtypes of respiratory
viruses, including respiratory syncytial virus A and B, influenza A (with
subtyping) and influenza B. ID-Tag RVP is designed to play a key role in
patient management, infection control and in countering the pandemic threat
of respiratory diseases.
Tm Bioscience is focused on gaining regulatory clearance from the FDA
for ID-Tag RVP as an in vitro device (IVD) in the United States, and is
also working towards Health Canada approval and CE marking in Europe. All
submissions are currently on track.
In January 2006, Tm Bioscience made the ID-Tag RVP commercially
available as an IUO (Investigational Use Only) device. Most recently, the
Company has signed distribution agreements for ID-Tag RVP in the
Netherlands and in Turkey. Tm anticipates securing additional distribution
agreements for the product with the goal of making the test available
globally.
About Resurrection Health Care
Resurrection Medical Center is part of Resurrection Health Care, a
family of health care services providing advanced medical care and
exceptional customer service with compassion and hope. The Resurrection
hospitals, nursing homes, retirement communities, home health services,
behavioral health programs and other services are conveniently located
throughout Chicago's neighborhoods. Resurrection Health Care is a
not-for-profit Catholic organization sponsored by the Sisters of the Holy
Family of Nazareth and the Sisters of the Resurrection. For more
information, visit reshealth.
About Tm Bioscience - Putting the Human Genome to Work(TM)
Tm Bioscience (TSX: TMC) is a Toronto-based diagnostics company
developing a suite of DNA-based tests for genetic disorders, drug
metabolism (pharmacogenetics) and infectious diseases.
Tm Bioscience has developed and commercialized Analyte Specific
Reagents* and a series of Tag-It(TM)** tests for a variety of genetic
disorders. These tests are based on Tm Bioscience's proprietary Tag-It(TM)
Universal Array platform, which utilizes a proprietary universal tag system
that allows for easy optimization, product development and expansion.
Tm Bioscience's Cystic Fibrosis (CF) test is the first multiplexed
human disease genotyping test to be cleared by the FDA as an in vitro
device (IVD) for diagnostic use in the U.S. It has also received CE mark
certification, allowing the test to be marketed for diagnostic purposes in
the European Union. In addition, the Company is developing a companion test
for the blood-thinning drug warfarin and a test for patients under
treatment for sepsis.
For more information, visit tmbioscience.
- Analyte Specific Reagent. Analytical and performance characteristics
are not established.
- For Investigational Use Only. The performance characteristics of these
products have not been established.
Forward-Looking Statements
This press release contains information that is forward-looking
information within the meaning of applicable securities laws. In some
cases, forward-looking information can be identified by the use of terms
such as "may," "will," "should," "expect," "plan," "anticipate," "believe,"
"intend," "estimate," "predict," "potential," "continue" or the negative of
theses terms or other similar expressions concerning matters that are not
historical facts. In particular, statements about the timing of the
anticipated launch of ID- Tag(TM) RVP, its expected role as a cornerstone
diagnostic product and as a tool to manage pandemic threats and the
expected regulatory status for ID- Tag(TM) RVP in both Europe and the
United States, are or involve forward- looking information.
Forward-looking information is based on certain factors and
assumptions. In particular, in making the statements in this press release,
the Company has assumed that it will submit ID-Tag(TM) RVP to the FDA for
regulatory approval in the first half of 2006, and that it will receive the
necessary approval in the same year. The Company has also assumed that
ID-Tag(TM) RVP will receive CE marking in Europe coincident with the U.S.
FDA approval, that it will be able to develop and manufacture sufficient
quantities of its ID-Tag(TM) RVP and that market penetration of ID-Tag(TM)
RVP will be such that it will serve a key role in the management and
treatment of patients infected by respiratory viruses. While the Company
considers these assumptions to be reasonable based on information currently
available to it, they may prove to be incorrect.
Forward-looking information, by its nature necessarily involves risks
and uncertainties including, without limitation, the difficulty of
predicting regulatory approvals, the timing and conditions precedent to
obtaining any regulatory approval, market acceptance and demand for new
products, the availability of appropriate genetic content and other
materials required for the Company's products, the Company's ability to
manufacture its products on a large scale, the protection of intellectual
property connected with genetic content, the impact of competitive
products, currency fluctuations, risks associated with the Company's
manufacturing facility and any other similar or related risks and
uncertainties. Additional risks and uncertainties affecting the Company can
be found in the Company's 2005 Annual Report, available on SEDAR at
sedar. If any of these risks or uncertainties were to
materialize, or if the factors and assumptions underlying the
forward-looking information were to prove incorrect, actual results could
vary materially from those that are expressed or implied by the
forward-looking information contained herein. The Company disclaims any
intention or obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise.
Tm Bioscience
tmbioscience
View drug information on Warfarin Sodium tablets.