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Setting the new gFOBT standard. Meeting 21st Century POCT Quality & Ease-of-Use Stds.
Diagnostica Corporation was started for one simple purpose: to end clinician frustrations and time loss with paper guaiac fecal occult blood test kits (gFOBT or commonly FOBT).
Diagnostica succeeded in creating the first pouch sealed FOBT with a built-in developer in a glass ampoule in an integrated plastic kit with a cover that snaps shut over the fecal sample: ColonTest.
Diagnostica has received its FDA 510(k) approval for Professional & OTC use and has received 2 patents with a 3rd pending.
ColonTest eliminates environmental contamination of paper & developer, coupled with positive sample retention. Ease of use & quick test TAT makes ColonTest THE choice for POCT QC meeting JC stds, so all kits are billable. ColonTest eliminates Infection Control Department concerns with loose fecal matter on paper kits & potential for contaminated developer bottles moving around the Emerg. Dept. in the 21st Century where many new microbes exist that were not present 40 years ago when the Hemoccult kit was developed.
ColonTest OTC generated sales for over one year through online test kit retailers. Our Colorectal Cancer screening study achieved over 70% of patients reporting results back to doctors compared to the usual 15-25%.
Colontest Professional review by ED doctors has resulted in a 100% demand for Colontest over cardboard kits, like Hemoccult from Beckman Coulter, with their separate, hard to find & potentially contaminated developer bottles.
Business Side of ColonTest: Diagnostica is seeking a partner to establish ColonTest in the hospital market. Colontest’s Ease-of-Use, Quality, Safety, Physician Demand and hospital ability to bill for all ColonTests used is a prime opportunity for manufacturer, distributors & hospitals, to modernize gFOBT testing, to meet current regulatory requirements for POCT standards.
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