imaware Inc. (“imaware,” “we,” “us” or “our”) offers an online wellness platform that utilizes blood biomarker, DNA, and/or RNA laboratory testing to provide insight into an individual’s health. These tests can provide insight into an individual’s risks for health-related conditions, including but not limited to, Celiac Disease, Rheumatoid Arthritis, Prediabetes, Cardiovascular Disease, Prostate Cancer, and Thyroid-related conditions. COVID-19 diagnostic and antibody tests are available as well. This Informed Consent describes our services and reviews the benefits, risks, and limitations to the test recipient, along with an explanation of how the sample, the test results, and relevant personal information will be accessed and used in providing our services.
imaware offers an online wellness-focused service that assists its subscribers by facilitating access to laboratory testing services that are ordered by a licensed physician or other authorized person and performed by a CLIA-certified laboratory (“Test Laboratory”), enabling subscribers to receive personalized health data and associated reports containing wellness-oriented information. imaware is not a clinical laboratory and does not collect blood or other specimens from subscribers. imaware is not a provider of medical or health services and does not provide any diagnosis, treatment, or medical advice and is not a substitute for an in-person medical evaluation. We encourage you to share any reports or information delivered by imaware, including the imaware Report (defined below), with your primary care provider or other qualified healthcare provider (“Health Professional”). If you think you may have a medical emergency or are experiencing severe or concerning symptoms, call 911 immediately. imaware does not provide, facilitate, or arrange any service that addresses or assists with medical emergencies.
There are certain conditions that, despite their severe impact on an individual’s quality of life, are currently underdiagnosed. A goal of imaware is to expand awareness of such conditions through convenient and simple blood, saliva, or other sample testing and actionable reports that are easy to understand. Our affiliation with multiple Test Laboratories allows imaware to enhance its wellness offerings by incorporating insights from test results into our condition-specific reports. We have also leveraged our relationships and expertise to make available COVID-19 testing.
Blood biomarkers, DNA, or RNA identified in the laboratory test can provide insight into the likelihood that an individual may have, or has previously had, the specified condition that they have chosen to have tested. For each test, imaware makes available a personalized report regarding the subscriber’s risk level associated with the tested sample, as well as general information regarding that condition (“imaware Report”). imaware’s insights are developed by identifying certain established biomarkers, genotypes, or viruses associated with particular conditions, based on scientific journals and other credible scientific resources.
In order to receive our services, you must hereby request and consent to the Test Laboratory’s performance of the blood biomarker, DNA, or RNA testing on your sample and hereby authorize the Test Laboratory to release your test results to imaware. The Test Laboratory will share with imaware only the data that is necessary to provide imaware’s services. You acknowledge that imaware does not perform any diagnostic testing.
The health and wellness insights provided by imaware in the imaware™ Report will be based on blood biomarker, DNA, or RNA data generated by the Test Laboratory and information then currently contained in scientific literature and other resources. Your imaware™ Report will include references to the studies that imaware used to prepare your health and wellness insights and an indication of the strength of the evidence supporting the influence of a particular biomarker or genotype on the risk of having a particular condition.
Once this Informed Consent has been signed, you’ll be able to request the desired laboratory test(s). To request a test, you may be required to provide certain additional information about you and your health. The request and any relevant additional information will be evaluated by a licensed physician or other authorized person and will be ordered if it is determined to be appropriate in the authorized person’s independent professional judgment. A collection kit will not be provided until a valid test order from the licensed physician or other authorized person is received. Depending on the particular test requested and ordered, your imaware collection kit may be mailed to the address listed in your user account, or sample collection at a specified location will be arranged. Details of the particular sample collection process are available on the imaware website or will otherwise be provided to you.
For many tests, imaware allows for an at-home sample collection process. Once you receive the imaware collection kit, you will need to follow the enclosed instructions to collect a sample and mail back your sample to the designated Test Laboratory. IF YOU DO NOT COLLECT AND RETURN YOUR SAMPLE IN THE COLLECTION KIT WITHIN SIXTY (60) DAYS OF RECEIPT, THE LABORATORY TEST MAY NOT BE PERFORMED AND YOU WILL NEED TO REORDER A COLLECTION KIT.
For some tests, collection will be arranged at a specified location (e.g., your workplace). Depending on your test selection and other circumstances, you will either collect your own sample in accordance with the instructions provided to you, or trained personnel will collect the sample from you. Your collected sample will then be packed and shipped to the Test Laboratory for analysis.
imaware will send an email to the address provided in your user account letting you know when your imaware Report is available on the imaware website. In certain cases, you may be contacted before the provision of the imaware Report to discuss your results. The test results from the Test Laboratory and your imaware Report will only be accessible via your user account.
imaware does not provide any diagnosis, treatment, or medical advice. imaware’s services are not intended to diagnose a disease or condition or to predict whether you may develop a disease or condition in the future. Always seek the advice of your Health Professional with any questions or concerns you have regarding your health and need for medical treatment or care, and never disregard professional medical advice or delay seeking it because of something you have read in the imaware Report. Reliance on any information in the imaware Report, or any other information provided by imaware or by other users of our services, is solely at your own risk.
Scientific developments occur at a rapid pace, and it is possible that new biomarkers or genotypes will be identified, or new information about the biomarkers or genes we examine will be discovered, after we prepare your imaware Report, which could affect the accuracy and completeness of the health and wellness information we provide. imaware does not warrant the accuracy, completeness, timeliness, or usefulness of your imaware Report and its content or other information or services provided through the imaware website or referenced on the Internet generally. imaware does not warrant the accuracy or completeness of the information and conclusions in the scientific journals and other resources referenced in the imaware Report.
imaware will ensure the Test Laboratory implements several safeguards to avoid technical errors, but there are general risks and limitations of laboratory testing and, as with all laboratory testing, there is a chance of a false positive or a false negative result. Other sources of error include sample mix-up, poor sample quality or contamination, and technical errors in the laboratory. Some biological factors, such as a history of bone marrow transplants or recent blood transfusions, may limit the accuracy of the results or prevent imaware services from being completed. If testing results are inconclusive, you may be asked for an additional sample(s). You hereby acknowledge and agree that imaware does not warrant and is not liable for the accuracy or completeness of the laboratory testing performed by the Test Laboratory.
The potential benefits of testing include that the results, along with other information, can help your Health Professional make informed recommendations about your care and behavior. Certain insights may also be helpful in informing your choices about nutrition, diet, and lifestyle upon consultation with your Health Professional. More information about the specific benefits of our services are available on the imaware website.
There are risks presented by using our services including, without limitation, the receipt of information about health that you may prefer not to know, and which may suggest conditions or problems that may be upsetting or even incurable, and you assume those risks by your consent.
imaware encourages you to have a follow-up visit with a Health Professional after reviewing the imaware Report. As a result, you may learn about health conditions and problems or potential health risks that you were not aware of before you utilized our services. You may experience stress, anxiety, or emotional or physical discomfort upon learning about potential health problems. There may also be additional risks of utilizing our services that are currently not known or foreseeable.
The laboratory tests require the collection of a small volume of blood or other appropriate sample (e.g., saliva or a nasal swab). Possible discomfort or other complications can potentially happen during sample collection. Further, collecting a blood sample may involve a risk for excessive bleeding, fainting, feeling light-headed, bruising, hematoma (blood accumulating under the skin), or infection (a slight risk any time the skin is broken). If a subscriber has a history of excessive bleeding or fainting while having blood work done, we advise avoiding self-collection of blood.
As discussed above, incorrect test results are possible. Further, sometimes for technical reasons, results cannot be generated. Another sample may be needed if results are not generated.
By signing this consent form, you acknowledge that your sample and any data received or created in connection with our services will be stored by imaware or third-party vendors and may be retained after testing for internal research, test validation, quality assurance, product improvement and/or educational purposes by imaware. Your consent allows us to share your data with third-party vendors or publish the results from your data, but any use or disclosure of the sample and any data will be done in an anonymized manner by either encrypting or removing personally identifiable information. You agree that imaware’s rights to process, store, and use your sample and data described herein can be exercised by imaware’s parent company, any subsidiaries, affiliates, joint ventures, or other companies under common control that imaware has now or will have in the future, as well as any company that merges with imaware, acquires imaware, or purchases its assets. You can withdraw your permission at any time hereafter. If you do so, your samples and your information in the possession of imaware will be deleted or destroyed.
By signing this Informed Consent, you acknowledge that imaware may decide to share your stored sample in an anonymized manner for various research purposes approved by an Institutional Review Board. imaware will do so only if you give us your separate consent which we will ask for through our research consent process.
If you have questions about the information included in this Informed Consent, or have questions or concerns after receiving your imaware Report, please contact us at email@example.com, or call us at 1.855.502.9273 for further information.
By signing below, I consent and agree to the following:
• I am 18 years of age or older, or I am the parent, legal guardian, or person acting in loco parentis of the individual whose sample will be tested.
• I have read this Informed Consent or have had the form read to me.
• I understand and voluntarily agree to the purpose, risks, benefits, and limitations of the services provided by imaware.
• I have had the opportunity to have my questions about imaware’s services answered.
• The Test Laboratory has my permission to release to imaware, and imaware has my permission to use, the test report and data generated for the purpose of providing imaware’s services and reports.