"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."
Ikonisys, Inc. will provide innovative, high quality in vitro diagnostics, medical devices and services globally that meet or exceed requirements of the healthcare community through Quality System effectiveness.
The Ikonisys Quality Policy states our commitment to provide health care products that exceed the norm. This extends to our clinical laboratories. At Ikonisys, nothing comes before quality. We are acutely aware that our patients and physicians are depending upon us to produce accurate, complete and timely laboratory results. We meet this need because we never forget that each specimen represents a person awaiting a laboratory report that they can trust to help in making important healthcare decisions.
Our extensive quality program begins with hiring and credentialing the highly trained professionals who perform our clinical laboratory testing. Proficiency testing, quality control, document control and quality assurance exercised at the pre-analytical, analytical and post-analytical stages ensure that each specimen receives the best quality testing that laboratory medicine offers.
Our commitment to quality is genuine and strong. Similarly, our commitment to compliance is based upon our belief that each person in our company will do the right thing every time, without compromise. We are pledged to this philosophy of ethical behavior and know that while this encompasses adherence to all applicable regulations and standards, it goes beyond what the law requires.
Our commitment to our patients requires no less.
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 41 US patents and more than 60 US patents pending. International patents 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.