Decision Diagnostics Responds to Shasta Technologies FDA Safety Warning Letter

April 30, 2014 09:15 ET
Company Reaffirms Its Categorical Commitment to Stand Behind, Manufacture and Sell the Safe and Effective GenStrip

LOS ANGELES, CA--(Marketwired - Apr 30, 2014) - Decision Diagnostics Corp. (OTCQB: DECN), and its subsidiary Pharma Tech Solutions, the FDA registered manufacturer and owner/operator for the popular GenStrip™, a medical device specifically designed to work with the Johnson & Johnson's LifeScan Ultra family of glucose testing meters, today will comment on the April 29, 2014 FDA issued safety communication about the quality systems issues at Shasta Technologies LLC, the former owner/operator of GenStrip. Shasta is no longer involved with GenStrip.

The company believes that the FDA communication is accurate in its criticism of the repeated failures of Shasta to comply with minimum standards of quality procedure and regulatory compliance. Their continued noncompliance was the motivating factor behind the March 20, 2014 acquisition of the GenStrip Intellectual Property and the 510(k). The existing product supplied by Shasta performed safely and effectively, met or exceeded its own 510(k) described standards, and there have been no reported incidents regarding patient safety or health and it is now under the regulatory control of the company's PharmaTech subsidiary and is fully compliant with the mandated quality procedure policies and documentation.

Keith Berman, Principal Executive Officer of DECN, commented, "We agree with the FDA that Shasta was incapable of properly overseeing GenStrip manufacturing. That is why our subsidiary, PharmaTech Solutions, has acquired GenStrip, its marks, and the 510(k). By virtue of our acquisition, we have assumed all manufacturing and quality systems responsibilities. Shasta's role in GenStrip has ended. We are pleased to announce that the Genstrip product has now been re-branded as, 'PharmaTech GenStrip 50.' GenStrip 50 will be enclosed in redesigned packaging and will shortly be available on our customers' shelves. More importantly, GenStrip 50 will continue to be made in the USA by the same leading diagnostic strip contract manufacturer."

Mr. Berman concluded, "Despite the fact that the issued FDA warning was directed solely to Shasta Technologies and is wholly their responsibility, as the acquirers of the technology and Intellectual Property, Decision Diagnostics and its subsidiary PharmaTech Solutions has committed to replace every box of GenStrip manufactured during Shasta's tenure as manufacturer and owner operator. This guarantee is regardless of where the patient may have purchased the product, or how any Genstrip seller or distributor may have acquired the product, its replacement will be honored. Any replaced product returned to PharmaTech will be destroyed."

Forward Looking Statements:

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 the Pharma Tech GenStrip 50, please visit the company's Web Sites: http://www.decisiondiagnostics.com/  or http://www.pharmatechdirect.com.  

GenStrip 50 test strips are a product of PharmaTech Solutions, Inc. and 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.

Contact Information

• Contact:
  Decision Diagnostics Corp.
  Keith Berman
  (805) 446-2973
  info@decisiondiagnostics.com