Good Samaritan Clinical Study
In October 2011, IRIS received an official approval from Good Samaritan hospital’s institutional review board in California to begin a clinical study on breast cancer. This is the beginning of a study that IRIS expects will eventually include patients from multiple hospitals and surgical centers from around the world. IRIS is now in the process of acquiring the necessary supplies to launch the project.
The IRIS Nano-Biochip™ for Breast Cancer, which has been under development for over a decade, will be used in this study. The genetic information collected from breast cancer tumors will be converted into digital information that will be stored in the IRIS BioWindows™ Medical Informatics System. The informatics system then compares the sample gene profile results to other historical breast gene profiles contained within the IRIS database.
This database represents breast tumor gene profiles with previously identified tumor characteristics, responses to therapy, as well as clinical outcome and patient survival data. This non-invasive laboratory test requires only a small amount of standard breast tumor material not otherwise needed for routine microscopic and/or histochemical testing and, therefore, does not require FDA approval for safety and effectiveness. The sample analyzed for this research is not an extra tissue sample but is a portion of the breast tumor material already being collected.
To enter this study, participants will need to complete a STRICTLY CONFIDENTIAL comprehensive ONLINE medical history questionnaire. IRIS BioTechnologies will analyze this information to identify preexisting risk factors, other medical diseases, family history, lifestyle habits and environmental exposures that may be helpful in understanding the causes of the disease. The participant may login to revise and/or update information in his or her personal profile at any time that new information becomes available. By providing IRIS with the most accurate and complete personal medical and family history, the IRIS artificial intelligence system will be able to better analyze the participant’s responses and ultimately provide the most useful and predictive profile for the specific tumor.
The security of a patient’s information is our top priority. In addition to IRIS BioTechnologies, ONLY the PATIENT will be able to access this paperless online database using a personalized password chosen by the patient. If a patient chooses to share this information with a health care provider, insurance or any other person or organization, the PATIENT will need to provide him/her with access to this confidential information.
If you are a patient that chooses to participate in this research study, you may also choose whether or not to disclose your personalized gene profile findings to your doctor or other health care professionals due to concerns about possible genetic discrimination. In this case, your doctor or other health care professionals may not benefit from the study findings contained in your personalized gene profile and, therefore, may not be able to make treatment decisions that could customize your specific medical care.
The federal Genetic Information Nondiscrimination Act (GINA) mandated in 2010 that all health insurance companies, group health plans and all employers with fifteen or more employees could not discriminate against you based on any genetic information. This law generally will protect you in the following ways: Health insurance companies and group health plans may not request your genetic information that we get from this research. Health insurance companies and group health plans may not use your genetic information when making decisions regarding your eligibility or premiums. Employers with 15 or more employees may not use your genetic information that we get from this research when making a decision to hire, fire, or promote you or when setting the terms of your employment.
Be aware that this Federal law does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance.
A new California state law, the CA Genetic Information Non-discrimination Act (SB 559), went into effect in September 2011. It amends two standing anti-discrimination laws in the state, the Jesse Unruh Civil Rights Act and the Fair Employment and Housing Act, by extending them to cover genetic discrimination in the areas of health and life insurance coverage, housing, mortgage lending, employment, education, public accommodations, and elections. The new law defines genetic information as an individual’s genetic tests, tests of family members, or the manifestation of a disease or disorder among an individual’s family members, and it covers information from genetic services and participation in clinical research.