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 the point-of-care
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 www.uspreventiveservicestaskforce.org.
About MedMira
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.
SOURCE MEDMIRA INC.
