IMD receives EPO patent for NADiA ultra-sensitive protein detection and cell phenotyping platform

IRIS International, Inc. (Nasdaq:IRIS), a leading manufacturer of automated in-vitro diagnostics systems and consumables for use in hospitals and commercial laboratories worldwide, and a provider of high value personalized diagnostics testing services through its CLIA certified molecular diagnostics laboratory, today announced that Iris Molecular Diagnostics (IMD)has been granted Patent No. EP1842226B1 by the European Patent Office (EPO) covering aspects of IMD's NADiA^® ultra-sensitive protein detection and cell phenotyping platform, which can detect proteins in the femtogram (1 quadrillionth) per milliter range and phenotype single cells.

The patent, entitled "Homogenous Analyte Detection" is based on technology that eliminates the need for solid phase incubation and wash steps that greatly simplifies assays on the NADiA^® (Nucleic Acid Detection Immunoassay) platform. The patent, which is effective through November of 2024, will be in force in 14 designated European countries, including Austria, Belgium, Denmark, Germany, Ireland, Italy, Finland, France, Portugal, Spain, Switzerland, Sweden, Turkey, and the United Kingdom. IMD is also seeking patent protection for this technology in the US, Australia, Canada, Japan, China and South Korea.

"We are delighted to have been granted this first broad patent including embodiments of the NADiA^® method in its most flexible and efficient homogenous format, which is more compatible with automated instruments platforms," stated Dr. Thomas Adams, IRIS Chief Technology Officer. "Our technology enables the in-solution detection of proteins, viruses, bacteria, cells and other materials, which are then measured using PCR amplification," he added.

To date, Iris Molecular Diagnostics has filed 17 national and international patent applications, seeking coverage of various aspects of the NADiA^® platform. For example, IMD is seeking patent protection worldwide on its NADiA^® Displacement Technology for protein detection that is expected to enable the detection of proteins present at lower than femtogram per millimeter concentration [in the attogram (1 quintillionth) per milliliter range] and also for its NADiA^® ProsVue™ technology which aids in the identification of patients at low risk of cancer recurrence post-radical prostatectomy.

IMD is the exclusive licensee of three issued patents from the University of California in the field of Immuno-PCR technology for ultra-sensitive protein detection.

The NADiA^® technology is a molecular diagnostics platform targeting the early detection of relapse of cancer and infectious diseases utilizing a novel ultra-sensitive and precise method for the detection of proteins. It is capable of performing these assays on real-time Polymerase Chain Reaction (PCR) systems, which are already in use in laboratories performing esoteric tests and for amplification and quantification of DNA. The technology has the ability to rapidly and effectively measure extremely low concentrations of proteins, which are under the detection threshold of current immunoassay methods.