"The most advanced applications for cancer diagnosis, based on rare cancer cell detection: Ikonisys will provide innovative, high quality medical diagnostic products that meet or exceed our customer's requirements, the expectations of the health-care community and the needs of the patients for whom our products are designed."
This Quality Policy states the commitment of Senior Management to meet or exceed customer, regulatory, and statutory requirements in the worldwide provision of innovative in vitro diagnostic medical devices and services. Management further commits to the maintenance of an effective Quality Management System. It is the responsibility of every employee to understand that System and to conduct their work accordingly.
The most advanced applications for cancer diagnosis, based on rare cancer cell detection.
Ikonisys is a cell based diagnostics company, that markets the proprietary Ikoniscope® Digital Microscope, designed to deliver highly accurate and reliable detection of rare cells. Utilizing advanced molecular and immunological markers, Ikoniscope-built applications are extensively used in the US and Europe for the diagnosis of a variety of cancers. Ikonisys has received FDA clearance for several automated, diagnostic applications also marketed in Europe under CE certification.
The Ikoniscope instrument is operated by the proprietary Ikonisoft® software system. This highly optimized software engine, operates the Ikoniscope robotic components, image acquisition and cell detection, offering true, hands-off slide handling for continuous, year-around operation.
A family of oncoFISH® diagnostic applications are built on the Ikonisoft engine foundation, optimally tuned for the detection of cancer-related chromosomal abnormalities utilizing FISH (Fluorescence In Situ Hybridization) . Clinical diagnostic applications are utilized for the diagnosis of different types of cancer including bladder (oncoFISH bladder), breast (oncoFISH her2), cervical (oncoFISH cervical), prostate (oncoFISH PTEN), lung (oncoFISH ALK) and a variety of hematological cancers utilizing the Explorer applications.
The exceptional ability of the Ikoniscope to detect rare cells has a direct application in the detection of circulating cancer cells (CTC), by combining up to 6, immunofluorescent and FISH markers.
Diagnostic results from the Ikoniscope/Ikonisoft system are reviewed by cytopathologists and cytogeneticists who provide the final diagnosis. “Cloud” based review of the slide scans is provided through the IkoniWAN application, providing unique flexibility for the clinical laboratory operations and full connectivity with commercial laboratory information systems.
Ikonisys has been awarded more than 20 patents and others are pending.
The Ikoniscope instrument and Ikonisoft software engine are manufactured and supported at the Ikonisys FDA and GMP compliant facility in New Haven, CT.