New York, New York, Point Roberts, WA - November 28, 2012
(Investorideas.com Newswire) Investorideas.com, an investor research
portal specializing in sector research for independent investors issues
an exclusive Q&A interview with Mr. Keith Berman , President and CFO
of Decision Diagnostics Corp. (
OTCBB: DECN). Mr.Berman discusses the market and opportunity for its lead product, GenStrip® Blood Glucose Test Strips.
Q: Investorideas.com
Keith for investors that aren't familiar with your company, can you
give a brief outline of your lead product and what differentiates
GenStrip® Blood Glucose Test Strips from its competitors?
A: Mr. Keith Berman, President and CFO
Our Shasta Genstrip product is an at-home diagnostic product for
the testing of blood glucose. Genstrip is designed specifically to run
on the venerable family of Johnson+Johnson's Lifescan family of meters.
This family of meters is in use by over 5 million diabetics worldwide.
At home diagnostic testing is a fast growing market, currently used
to monitor blood glucose, primarily as a result of modern society
lifestyle issues, and is the most important aid in the fight against
spread of diabetes. Genstrip is the first product to reach the market in
almost a decade as an alternative to brand name diagnostic products.
Since its predecessor generic test strips were sold in the late 1990s,
the market for at-home testing has grown 20-fold.
Q: Investorideas.com
A report from MarketResearch.com recently noted - Although the
blood glucose testing segment of the in vitro diagnostics (IVD) industry
is mature, certain segments of the market, such as home testing devices
for diabetes management, will exhibit strong growth . Can you give
investors insight as to the size of the market and opportunity?
A: Mr. Keith Berman, President and CFO
At home glucose testing is the fastest growth segment of personal
health management. The personal diabetes meter has matured to become
another must-have, must-need, home appliance. While at-home testing is
not a new market, my father for instance tested his glucose levels using
at-home urine test strips in the 1970s, the last decade has seen
explosive growth in monitoring diagnostic products The market for
at-home blood glucose testing reached $1 billion per year for the first
time in 2000. By 2017 the market is expected to reach $32 billion
worldwide. A rule of thumb is that the U.S. and Canada account for
one-half of the market, the rest of the world the other half.
Q: Investorideas.com
According to your SEC filings the Company is underway with the FDA approval process for
GenStrip®. Can you give us a brief outline of the history and the process for approval?
A: Mr. Keith Berman, President and CFO
Shasta Genstrip, like all at-home diagnostic products require
approval of the U.S. FDA. The process that Genstrip traveled through,
called Substantial Equivalency Review ("SE"), was first put in place in
the mid-1970s as a way to speed up the regulatory process. Over the last
three decades this "speedy" process has morphed into something never
envisioned by the U.S. Congress when these laws and regulations were
first passed with near unanimous support. Approvals now take in excess
of two years. The SE 510k application was filed in early December 2010.
Q: Investorideas.com
If and when the Company does receive FDA approval what is the
timeline for distribution into the sales channels? And how would this
typically roll out?
A: Mr. Keith Berman, President and CFO
We have had plenty of time to ready ourselves for the ultimate FDA
approval of Genstrip. Because of its unique design all of the potential
Genstrip customers already make use daily of original manufacturer's
platform. Our potential customer base is well known, well studied, and
by new product standards, very large.
By law the company could not take orders for Genstrip until there
was/is an approval from FDA, but since February 2011 we have been
allowed to do some demonstration projects to collect
data
etc. We used this time to familiarize the market with the upcoming
product through the company's normal and historical distribution
channels. We secured a supplier contract with Walmart Stores in an
incredible 35 days. We have accepted, as a part of our overall
responsibilities, working with the Genstrip manufacturer to make product
forecasts. We readied the Genstrip Value Proposition. And, it has not
hurt that all of the potential consumers of Genstrip have used the
predecessor product for, in some cases, almost a decade.
Decision Diagnostics Company website http://www.decisiondiagnostics.com/
DECN SEC quarterly filing
http://biz.yahoo.com/e/120820/decn10-q.html
More info on DECN at Investorideas.com
http://www.investorideas.com/CO/DECN/
About InvestorIdeas.com:
InvestorIdeas.com is a leader in investor stock research by sector,
featuring stock news, commentary and trading alerts in leading sectors
including biotech, tech, mining, energy, water, renewable energy,
beverage stocks and more.
Follow Investorideas.com on Twitter
http://twitter.com/#!/Investorideas
Follow Investorideas.com on Facebook
http://www.facebook.com/Investorideas
Follow Investorideas.com News on Linkedin.com/today at
http://www.linkedin.com/today/investorideas.com
Sign up for the free investor news and stock alerts at Investorideas.com
http://www.investorideas.com/Resources/Newsletter.asp
Disclaimer/ Disclosure: The Investorideas.com is a third party
publisher of news and research Our sites do not make recommendations,
but offer information portals to research news, articles, stock lists
and recent research. Nothing on our sites should be construed as an
offer or solicitation to buy or sell products or securities. This site
is currently compensated by featured companies, news submissions and
online advertising.
Disclosure: Investorideas.com has been compensated one hundred
fifty thousand shares for news and content publication and distribution
for 45 days
http://www.investorideas.com/About/Disclaimer.asp
BC Residents and Investor Disclaimer: Effective September 15 2008 -
all BC investors should review all OTC and Pink sheet listed companies
for adherence in new disclosure filings and filing appropriate documents
with Sedar. Read for more info:
http://www.bcsc.bc.ca/release.aspx?id=6894
800-665-0411 - Source -
www.Investorideas.com and Decision Diagnostics
About NASDAQ 
Decision Diagnostics Corp. (
In March 2012 and then again September 2012 representatives of
the company and Shasta Technologies LLC met face-to-face with the FDA to
ask questions and respond to FDA comments and to present its case in an
effort to complete the FDA review process. Subsequently Shasta
Technologies LLC and the company have received and responded to a short
series of follow up questions and comments by FDA.