HALIFAX,
March 11, 2013 /CNW/ - MedMira Inc.,
(MedMira) (TSXV: MIR), a developer of rapid diagnostic technology
and solutions, announced today that it has submitted an application
for its Multiplo Syphilis/HIV rapid test (also known as Multiplo
TP/HIV) to the World Health Organization (WHO) Prequalification of
Diagnostics program. The Company received a letter of
invitation from the WHO to submit Multiplo Syphilis/HIV for
prequalification. This invitation comes as MedMira's Reveal
HIV rapid test is in the final stages of the WHO prequalification
program.
As a leader on global health matters, one of the
WHO's focus areas is the elimination of mother-to-child
transmissions of both Syphilis and HIV. Globally, Syphilis
caused 300,000 stillbirths and neonatal deaths in 2008, and 390,000
children were newly infected with HIV in 2010.
"Independent studies led by our team in
Canada and India and Canadian Institutes of Health
Research funded meta-analyses have proved that point-of-care tests
for HIV, Syphilis, and related co-infections, offer expedited
screening solutions for pregnant women and marginalized populations
for both resource rich and resource poor settings. Their high
accuracies facilitate expedited clinical decision making, allow for
same day triage to staging and treatment, and prevent loss to
follow up of patients. Point-of-care technologies are the now and
the future of diagnostics," said Dr. Nitika Pant Pai, MD., PHD an
Assistant Professor of Medicine at McGill
University, and a medical scientist at the Research
Institute of the McGill University
Health Centre. "The technology is a game changer."
The WHO recommends that all pregnant women be
screened for Syphilis, HIV and other diseases to prevent passing
these infections on to their babies. This recommendation is
not always carried through to practice due to lack of resources,
under developed healthcare systems, and general lack of public
awareness. However, there is currently a widespread scale-up
of HIV screening for pregnant women which presents a "golden
opportunity" to screen for Syphilis at the same time, capitalizing
on existing infrastructure, creating greater awareness, and
preventing babies born with Syphilis and HIV.
"Our Multiplo Syphilis/HIV combination test will
positively impact screening programs for pregnant women, as well as
others. We were pleased to receive the invitation letter and
welcome the opportunity to work with the WHO, a leader in public
health, to bring these testing solutions to global healthcare
markets," said Neeraj Vats, Director of Technology and Business
Affairs, MedMira Inc. "Our Multiplo tests, which provide
simultaneous results for multiple diseases, deliver the efficiency,
performance, and results needed to support the prevention of
mother-to-child transmission of diseases like Syphilis and
HIV. As both developing and developed regions of world deal
with limited healthcare dollars and increasing co-infections,
screening for HIV alone is no longer enough."
The Company has submitted the application form
and is preparing the in-depth Multiplo Syphilis/HIV product
dossier. The WHO Prequalification of Diagnostics program
undertakes a comprehensive assessment through a standardized
procedure. The prequalification procedure includes three main
components:
- Review of an application form and product dossier
- Laboratory evaluation of the product; and
- Inspection of the manufacturing site(s).
Vats continued, "We are very familiar with the
WHO process for evaluating diagnostics, just having recently
completed the final steps for prequalification of our Reveal HIV
product. The invitation to submit an additional test for
approval coming so quickly on the heels of our first submission
clearly demonstrates the capabilities, performance, and reputation
of our distinctive technology platform within the industry."
About MedMira
MedMira is a leading developer and manufacturer
of flow-through rapid diagnostics. The company's tests provide
hospitals, labs, clinics and individuals with reliable, rapid
diagnosis for diseases such as HIV and hepatitis C in just three
minutes. The company's tests are sold under the Reveal®, Multiplo™
and Miriad brands in global markets. MedMira's rapid flow-through
HIV test is the only one in the world to achieve regulatory
approvals in Canada, the United States, China and the European Union. MedMira's
corporate offices and manufacturing facilities are located in
Halifax, Nova Scotia, Canada. For
more information visit MedMira's website at www.medmira.com.
This news release contains forward-looking
statements, which involve risk and uncertainties and reflect the
Company's current expectation regarding future events including
statements regarding possible future growth and new business
opportunities. Actual events could materially differ from
those projected herein and depend on a number of factors including,
but not limited to, changing market conditions, successful and
timely completion of clinical studies, uncertainties related to the
regulatory approval process, establishment of corporate alliances
and other risks detailed from time to time in the company quarterly
filings.
Neither TSX Venture Exchange nor its
Regulation Services Provider (as that term is defined in the
policies of the TSX Venture Exchange) accepts responsibility for
the adequacy or accuracy of this release.
SOURCE MEDMIRA INC.