MedMira Files Pre-IDE with FDA for New Rapid HIV Test to Meet Demand for
Increased Routine Screening in the US
Company commends USPSTF on new recommendations for routine HIV screening at
HALIFAX, Nov. 30, 2012 /CNW/ - MedMira Inc., (MedMira) (TSXV: MIR), a
developer of rapid diagnostic technology and solutions, commends the U.S.
Preventive Services Task Force (USPSTF) on its new guidelines calling for
routine HIV screening of all people aged 15-65 and all pregnant women in the
United States during the normal course of medical care.
The new guidelines will significantly increase the number of people being
screened for HIV, as previous recommendations and insurance policies only
covered routine testing for individuals considered at high risk.According to
the US Centers for Disease Control and Prevention (CDC), approximately 1 in 5
of the 1.2 million people in the US living with HIV do not know that they are
infected.The new recommendations, which are available until December 17,
2012 for public comment, are in line with the CDC's recommendations for
routine HIV testing for people 13 years of age or older.
"We believe that the USPSTF's new recommendations on routine HIV testing will
have a significant influence on the early treatment of those individuals
unaware of their HIV infection, as well as preventing the further spread of
the disease," said Hermes Chan, CEO, MedMira Inc."As HIV testing becomes
part of routine visits to doctor's offices and convenience care clinics, we
expect to see an increased demand for high quality, efficient, rapid tests
designed for use at the point-of-care.With this in mind, we are bringing a
whole blood version of our Reveal G3 rapid HIV test to US healthcare
providers.Our technology enables a 3 minute procedure and instant results
for HIV screening, and a highly cost-effective diagnostic tool for healthcare
providers and their patients."
Earlier this month, MedMira submitted a pre-IDE (Investigational Device
Exemption) information package to the U.S. Food and Drug Administration (FDA)
for a whole blood rapid HIV test.The Company currently sells its Reveal G3
Rapid HIV-1 Antibody Test in the US for use in laboratories and
hospitals.The new version will be aimed at physician offices, convenience
care clinics, mobile testing, and large scale public health programs where
whole blood specimens are preferred and much of the new routine HIV screening
will take place.
About the U.S. Preventive Services Task Force (USPSTF)
The USPSTF is an independent group of national experts in prevention and
evidence-based medicine that works to improve the health of all Americans by
making evidence-based recommendations about clinical preventative services,
such as screenings, counseling services, and preventative medications.USPSTF
recommendations have formed the basis of the clinical standards for many
professional societies, health organizations, and medical quality review
groups.To learn more about USPSTF visit
MedMira is a leading developer and manufacturer of flow-through rapid
diagnostics and technologies. MedMira is the only Canadian company to be
awarded US Army contracts for the development of rapid tests for HIV and
Hepatitis viruses.The Company's testing solutions 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 is
located in Halifax, Nova Scotia, Canada. www.medmira.com.
This news release contains forward-looking statements, including statements
relating to growth in the Company's business, earnings and profitability, and
trends in demand for the Company's products, 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.
MedMira Contact: Andrea Young, Corporate Communications Tel: 902-450-1588
SOURCE: MEDMIRA INC.
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CO: MEDMIRA INC.
ST: Nova Scotia
NI: BTC HEA
-0- Nov/30/2012 14:09 GMT
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