Company's most advanced rapid HIV test expands product
applications to point-of-care settings
HALIFAX, April 20, 2015 /CNW/ - MedMira Inc.
(MedMira) (TSXV: MIR) has completed the submission of a supplement
to their existing Premarket Approval for the United States Food and
Drug Administration (FDA) approval of the next generation of its
Reveal rapid HIV test. The supplement requests FDA approval of
Reveal® G4 Rapid HIV-1 Antibody Test (Reveal G4),
which adds the detection of HIV antibodies in fingerstick and
venipuncture whole blood, to the product's current capabilities in
testing serum and plasma specimens.
"Reveal G4 represents a significant milestone in our sales and
marketing expansion in the United
States and this submission marks the first in a series of
regulatory submissions we will be making as we introduce new
products in this market," said Dr. Kevin
Jones, Senior Director, Global Sales & Marketing,
MedMira Inc. "Reveal G4 also builds on MedMira's commitment to
delivering the most innovative rapid testing solutions to our
customers. The whole blood capabilities in Reveal G4 will expand
product applications to physician offices, mobile testing vehicles,
and convenience care clinics where much of the HIV testing is
taking place as healthcare providers implement the latest
guidelines for routine screening."
Built on MedMira's patented Rapid Vertical Flow
Technology™ (RVF) platform, Reveal G4 offers
point-of-care (POC) users a simple 3-step whole blood procedure
which is completed in less than three minutes. The product
will be sold in three distinct packaging formats, designed to meet
the needs of a broad range of customers, including fingerstick
whole blood (POC format), venipuncture whole blood/serum/plasma
(LAB+ format), and serum/plasma (LAB S/P).
MedMira has successfully served customers in hospitals and
laboratories with a serum/plasma version of its Reveal rapid HIV
test for the past decade. Reveal is routinely ranked as a top
performer in these market sectors with the highest sensitivity and
specificity as well as performance comparable to complex laboratory
systems.
The submission to the FDA is based on results from multi-center
clinical trials conducted across the
United States where Reveal G4 showed excellent results with
fingerstick and whole blood specimens from a broad range of
demographics. The additional whole blood capabilities of
Reveal G4 will enable healthcare providers to better serve
individuals 15-65 years of age and pregnant women seeking routine
screening, helping to reduce the 50,000 new HIV infections in the
US each year, including 100 to 200 babies born with HIV.
About MedMira
MedMira is a leading developer and manufacturer of vertical flow
rapid diagnostics. The Company's tests provide hospitals, labs,
clinics and individuals with instant diagnosis for diseases such as
HIV and hepatitis C in just three easy steps. The Company's tests
are sold under the Reveal, Multiplo™ and Miriad™ brands in global
markets. Based on its patented Rapid Vertical Flow Technology,
MedMira's rapid 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.com. Follow us on Twitter and
LinkedIn.
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 approval and launch of new products, 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.