Iris Biotechnologies Inc., a development stage life sciences company, develops solutions for the detection and monitoring of monogenic and complex genomic diseases. The company offers ‘Health Passport’ in its BioWindows 2.0 Informatics System. Health Passport is a HIPAA compliant, Web based medical information storage system that allows participants to grant sharing capabilities of their confidential medical and lifestyle information to physicians and/or family members anywhere in the world. This allows families to build multi-generational medical family trees that would help assure that they receive more personalized care. The company has developed a manufacturing system with the capabilities to produce various Nano-biochips with a choice of messenger ribonucleic acids (RNAs), microRNAs, proteins, or other biomarker probes for the diagnosis and prognosis of breast cancer, colon cancer, and various other diseases. Its Nano-biochip manufacturing and usage tracking process has been tested with 2D and 1D barcode scanners on both labeled and stamped products in conjunction with touch screen functions, and the company has streamlined the automated patient sample processing protocols. The company is collaborating with Good Samaritan Hospital (San Jose) to begin a clinical research study to determine the effectiveness of tissue genetic testing in patients undergoing surgery for breast cancer. The company has the capability to launch the clinical BreastCancerChip through the Clinical Laboratory Improvement Amendments of 1988 laboratory certification without the U.S. Food and Drug Administration (FDA) approval, similar to the Oncotype Dx test offered by Genomic Health Inc. With FDA approval, all of the company’s tests could be performed in any certified laboratory. The Iris BioWindows Informatics System for Personalized and Targeted Medicine handles the analysis of the gene expression and genetic variation data, as well as protein and other biomarker information collected by the Nano-Biochip. BioWindows is an artificial intelligence system, which includes a database with molecular signatures, in-depth patient demographics and lifestyle information, family medical histories, and treatment-response profiles for various diseases. The company’s Nano-Biochips are special silicon chips with multiple functions. Solution The company’s nano-biochip technology platform is developed using a convergence of scientific disciplines in nanotechnology, semiconductor manufacturing, microfluidics, chemistry, molecular biology, genetics, genomics, and information technology. The company’s technology platform includes oligonucleotide, peptide nucleic acid probes with binding affinity and specificity that are the ideal length and highly purified, protein biomarkers, and other molecules; a proprietary binding system to secure probes to a soft metal chip surface; controlled probe spacing and chip surface design to maximize sensitivity; microfluidics and the use of paramagnetic labels with a magnetic field to improve hybridization speed; a chip design and manufacturing process; the use of robotics for precise automated chip manufacturing; and an information technology system based on proprietary algorithms for analysis, correlation and classification of test results. Microfluidics deals with the precise control and manipulation of microliter and nanoliter volumes of fluids. The Iris BioWindows database comprising data fields for patient demographic information, personal medical history, family medical history, and gene expression information is in use for storing actual patient information. Physicians, with the patient’s consent, could view information by choosing any medical record from their personal list of patients. With the company’s manufacturing system, it intends to build medical products, such as the BreastCancerChip, ColonCancerChip, Comprehensive Cancer Chip, NeuroChip, CardioChip, and MetabolicChip, as well as chips for other applications, including veterinary, agricultural, and environmental problems. The company also intends to use its BioWindows database to enable drug development, stem cell research, and evolving clinical applications. The company is also working on gene markers for a CancerChip and specific markers associated with prostrate, lung, liver, kidney, and ovarian cancers. Certain genes associated with schizophrenia, Alzheimer disease, autoimmune system disorders, and metabolic and drug metabolism disorders have also been reviewed. The company is continuing to work on the selection of newly discovered genes to be included in other products, such as the NeuroChip and CardioChip. Sales and Marketing The company’s sales and marketing would be done initially through partners, distributors, and company representatives. In the United States, the initial customer base that the company wishes to target once its products are ready to be introduced to the market includes major clinical research institutions and companies, such as Stanford, UCSF, M.D. Anderson Cancer Center, the National Cancer Institute, Quest Diagnostics Incorporated, Laboratory Corporation of America Holdings, Sutter Medical, and Kaiser Permanente. Intellectual Property The company has six U.S. patents plus a portfolio of patents issued worldwide. Government Regulation The company and its contract medical product manufacturers are subject to periodic inspection by the FDA and other authorities where applicable, and are required to comply with the applicable FDA current Good Manufacturing Practice regulations. Competition The company faces competition from Genomic Health Inc. and Agendia B.V. History Iris Biotechnologies Inc. was founded in 1999. The company was incorporated in 1999 under the laws of the state of California.
iris biotechnologies inc (IRSB:OTC US)
5201 Great America Parkway
Santa Clara, CA 95054
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