Decision Diagnostics Corp. (OTCBB: DECN) is the parent company of a nationwide prescription and non-prescription diagnostics and home testing products distribution business. The U.S. FDA, in a manner similar to prescription drugs, regulates diagnostic test kits and at-home patient testing products similarly to the regulation of prescription medicine. However, the products we distribute, for the most part, do not require a doctor's prescription for anything other than insurance benefit compliance. Our business model works well in this regulated environment.
We have also continued to ready the company, subject to receipt of an expected FDA 510(k) approval, to introduce a proprietary diagnostic product, the Shasta Genstrip, for at-home testing of blood glucose, an estimated $22.5 billion worldwide market. Shasta Genstrip will compete directly with one of the largest worldwide platform manufacturer for at-home blood glucose testing, a product currently used daily by over 3 million diabetes afflicted Americans. In anticipation of the introduction of Genstrip, currently in the FDA approval process, we have phased out sales of those brand name products that have been a backbone of our current distribution business but will, in the future, would have us compete directly with our Shasta Genstrip product.
Typically, and except for our Shasta Genstrip product, which is an alternative product, we distribute name brand products manufactured primarily by large U.S. and international pharmaceutical companies. The company directs its marketing efforts to ambulatory and semi-ambulatory older Americans afflicted with diabetes and complications caused by diabetes and old age. The company, originally a medical IT company with proprietary IT product lines, acquired its medical products distribution business in late 2004 through a merger with Phoenix, Arizona based CareGeneration, Inc. We have grown the original CareGeneration business through subsequent acquisitions of private businesses and strategic partnerships with larger private pharmacies.
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.
DECN SEC quarterly file
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