May 01, 2014 09:20 ET
LOS ANGELES, CA--(Marketwired - May 1, 2014) - Decision Diagnostics Corp. (OTCQB: DECN), and its subsidiary Pharma Tech Solutions, the FDA registered manufacturer and owner/operator for the popular GenStrip™ 50, a medical device specifically designed to work with the Johnson & Johnson's LifeScan Ultra family of glucose testing meters, today added clarification to its discussion about its recently acquired GenStrip product. The company stated that there is no question that GenStrip was born of the highest manufacturing practices and adheres closely and consistently meets or exceeds its own documented specifications cleared by the FDA in November 2012.
GenStrip has always been safe, effective, reliable and in full compliance with stringent regulatory procedural standards. The recent FDA letter was singularly directed to Shasta Technologies LLC. No other company was included, either, directly or indirectly. PharmaTech was in full agreement with the FDA in its criticism of the deficiencies of the Shasta quality procedures and monitoring system. That shared opinion significantly contributed to the acquisition of GenStrip and the immediate quality and regulatory oversight that is now provided by PharmaTech.
Mark DuVal, President of DuVal & Associates, P.A., an attorney with 30 years' of FDA legal experience and current regulatory counsel to PharmaTech states, "The FDA abstractly talks about a deficient quality system by a previous company named Shasta. The quality system deficiencies stated do not relate to PharmaTech or the actual safety or effectiveness of the GenStrip product, which is safe and effective and always has been."
The GenStrip product, currently available through retailers across the nation, was manufactured by an FDA registered and ISO certified contract manufacturing facility that is respected throughout the industry. This manufacturer, Conductive Technologies, Inc. ("CTI"), adheres to consistent and rigid quality procedures. All of the products CTI produces routinely exceed the standards established by FDA. In order to reinforce its concerns about quality systems, PharmaTech has established its QA/QC Management and Policies office within CTI's facilities. This office will centralize and manage the production and regulatory functions related to GenStrip manufacturing. We will also be better able to improve the responsiveness of manufacturing to customer needs particularly functions related to our new Private Label brand strategy.
Keith Berman, President of PharmaTech, said, "PharmaTech has decided to subtly change the packaging of our existing Genstrip product with our newly rebranded GenStrip 50. GenStrip 50 can be immediately viewed at www.pharmatechdirect.com/genstrip.html. Our last several weeks have been active and positive as we are hitting our stride. We have acquired GenStrip, assumed manufacturing and quality control, and are ready to aggressively move it forward. The market remains huge, we are perfectly positioned, and the opportunity still available for our taking."
Mr. Berman concluded, "The company's Board plans to announce a date for a shareholder conference call soon after we file our Annual Report on Form 10-K with the SEC. This conference call will focus on the progression of our GenStrip manufacturing and quality plan, our new Discretion product, our pending uplist to OTCQX, and a discussion of our GenStrip opportunities."
This release contains forward-looking statements about our business or financial condition that reflect our assumptions and beliefs based on information currently available. We can give no assurance that the expectations indicated by such forward-looking statements will be realized.
There may be other risks and circumstances that we are unable to predict. When used in this release, words such as "believes," "expects," "forecasts," "intends," "projects," "plans," "anticipates," "estimates" and similar expressions are intended to identify forward-looking statements, although there may be certain statements not accompanied by such expressions.
For further information about GenStrip 50, please visit the company's Web Sites:
GenStrip™ test strips are not manufactured, distributed, endorsed, or approved by nor associated with LifeScan®, Inc., a Johnson & Johnson® Company, manufacturers and distributors of the OneTouch® Ultra® Family of Meters and OneTouch® Ultra® test strips.