For the past decade Iris BioTechnologies has been perfecting the 21st Century tools necessary to bring P4 medicine to the clinic. Iris’s state-of-the-art Nano-biochips™ and BioWindows™ medical informatics system are capable of capturing and analyzing the many alterations in cancer pathways by capturing mRNA, microRNA, proteins or other biomarkers. Our patented products were developed to overcome the sensitivity, specificity, speed and cost limitations of present state-of-the-art microarray technology. The Iris products are designed to be FDA approved, enabling them to be used in any certified laboratory in the United States.

All life on this planet is based on cells. If you were able to observe yourself developing from the single cell that started you on your journey you would quickly come to realize that you are billions of cells forged into a whole functioning interdependently. Interdependence, whether in a human society or a cellular society, is all about cooperation and control; cooperation and control requires a language.

The language of all cellular societies is based, not on words, but on chemistry. Using molecules where we use words, our cells construct sentences from chains of proteins that inform, command, and instruct each other. Our cells use the information found in our genome to construct those proteins. Genes conserve the language but cells can use it to converse. The breakdown in cellular communication, whether inherited or acquired, results in disease. The practice of P4 medicine - personalization, prediction, prevention, and participation - is based on understanding this communication breakdown.

While it is useful to study the inherited or acquired genetic variations of a disease, it is more important to measure the actual activity of those genes implicated in a specific tumor and correlate that information with life dynamics and drug response. The most complete genomic testing is about uncovering a tumor’s genetic signature by measuring the gene expression activity that drives the aggressiveness of the tumor, its possibility of recurrence and what specific type of therapeutic regimen would save and optimize the patient’s quality of life. Without a clinically accurate tool to measure the relevant genetic/genomic malfunctions involved, cancer diagnosis is a trial and error process leading to unnecessary or ill-directed therapy with unintended risks and adverse side effects.

We have developed our first biochip to identify gene expression patterns in the multiple varieties of breast cancer. It has become apparent to us that there is an acute need for a robust staging classification system, as well as more effective predictive and prognostic tools to assist in medical treatment decisions. Our Nano-Biochip and BioWindows™ informatics program are designed to enable a treating physician to quickly prescribe a personalized treatment regimen that will have the greatest probability of success for each individual patient’s particular form of breast cancer.

Sustainable medicine for the 21st Century is about personal and societal accountability, the participatory aspect of P4 medicine. While Iris’s present focus is on personalizing therapy our long-term goal is prediction and prevention. One of the growing challenges facing our healthcare system is managing the care for the growing number of people with chronic diseases. Promoting healthy lifestyles and a cleaner environment to prevent chronic illnesses and working aggressively to help patients with chronic illnesses manage their own health is one of the greatest challenges facing our nation.

In a recent article in Nature, National Institutes of Health Director Francis Collins outlined five future goals that are necessary for the full implementation of P4 medicine: open access to genomic data, technological development to facilitate continued genomic progress, studies aimed at finding genetic and environmental risk factors, targeted treatments based on genomic data, and appropriate policies to support genomics research. Iris BioTechnologies is in full agreement with these goals and is actively involved in two of them.

The recently passed health care bill mandating an independent Patient-Centered Outcomes Research Institute is a first strong policy decision in support of genomics research and targeted medicine. Also, New York District Judge Robert Sweet’s March 29, 2010 ruling that Myriad Genetics' BRCA1 and BRCA2 patents are invalid is the first step for open access to genomic data. It is our position that open access to genomic data will both stimulate business and create a better, more cost effective health care system for all.