Disclosure of Arivale’s Current Wellness Support and Limits to Medical Support
Effective Date: June 3, 2016
IMPORTANT INFORMATION AND LIMITATIONS ABOUT THE WELLNESS SUPPORT WE PROVIDE
WHAT WE DO:
Arivale is a program based on Systems Biology — a holistic approach to understanding health by looking at different biological systems and the interactions of these systems.
The Arivale Program provides individuals with a personalized “data cloud” made up of data gathered from four sources: 1) sequenced genetic variants associated with diet and wellness; 2) biological markers from clinical laboratory tests conducted on blood and saliva samples; 3) data on the diversity of gut microbiome present in a stool sample; and 4) data on the quality and quantity of food, sleep and exercise, as reported in lifestyle surveys, health assessments, and data from a device that tracks exercise and sleep.
Arivale’s Program provides ongoing personal and evidence-based support for actively-enrolled Arivale Participants limited to optimizing wellness. Our team has integrated current scientific understanding of the data points associated with these sources of wellness. Clinical laboratory test results (which are ordered and reviewed by external physicians) and recommendations are presented to each participant and explained by credentialed Arivale Coaches with whom participants work one-to-one through the Program. Participation in the Arivale Program is not a substitute for primary, urgent, or chronic medical care.
IN PARTICIPATING IN OUR PROGRAM IT IS IMPORTANT FOR YOU TO UNDERSTAND THAT, IN MANY INSTANCES, SCIENTIFIC RESEARCH HAS NOT YET CONCLUSIVELY DEMONSTRATED THE EXACT BIOLOGICAL IMPACT THESE SPECIFIC DIET AND LIFESTYLE MODIFICATIONS HAVE ON OPTIMIZING ONE’S WELLNESS. OUR GOAL IS TO ADVANCE “SCIENTIFIC WELLNESS” AND YOU CAN BE PART OF A MOVEMENT TO FURTHER THIS RESEARCH AND OUR UNDERSTANDING.
THE SCIENCE WE RELY UPON IS EXCITING BUT STILL EVOLVING
Scientific Wellness is a brand new industry! We created it at Arivale. So of course, the science continues to evolve as researchers investigate the increasingly individualized behavioral, biological and molecular mechanisms of wellness. New studies will continue to be published, supporting the evolution over time of the recommendations Arivale Program Participants receive from their Coaches. Like other areas of health care, many of the findings we report, and the recommendations we make, involve areas where there is significant scientific agreement, but not yet scientific consensus. In general, Arivale’s recommendations are based on:
There are millions of genetic markers or “variants.” Scientists study certain genetic variants and the degree to which they are associated with particular physiological characteristics (such as a reduced capacity to absorb Vitamin B12). Such an association or “correlation” does not necessarily mean the relationship is absolutely established but rather that there is evidence to suggest a link between the genetic marker and such physiological characteristics.
Arivale reports on a specific set of pre-selected genetic markers identified in clinical laboratory test reports ordered and received by an external physician and incorporated in to the Arivale program by our clinical team and coaches. We report certain specific genetic variants associated with widely understood wellness characteristics for which there are also established biological markers with the potential to be favorably impacted by lifestyle changes (e.g., changes in diet and exercise). In deciding which genetic variants and wellness associations to discuss with participants, Arivale looks to correlations that have been studied in large populations and documented in published scientific literature. For most of the associations we report, there is a significant, though not always conclusive, body of clinical evidence suggesting a beneficial impact on associated wellness biomarkers (e.g., cholesterol levels) from dietary or lifestyle interventions that may reduce the risk or impact of well understood chronic conditions and/or may help our program participants strive to “live well” with those chronic diseases or conditions.
We do not diagnose or treat medical diseases, or make recommendations to program participants for any disease or condition beyond those generally established as within the scope of wellness (e.g., cardiovascular health, obesity, and diabetes risk).
We do not report genetic variants known or associated with the diagnosis of diseases or conditions beyond the scope of wellness, or genetic variants associated with an increased risk of diseases or conditions beyond the scope of wellness, such as the BRCA gene mutation or other genetic variants associated with the risk of cancer.
Arivale is at the leading edge of such research into scientific wellness. With your consent, Arivale will enable scientific research teams to access your de-identified genetic sequence, lifestyle information, assessment, and biological data, including the genetic sequence data that the Arivale wellness program does not receive, access or report to you. The purpose of this research, as defined in the optional Consent for Research agreement, is to advance the understanding of the role of genetics and systems biology with respect to maintaining and improving health and wellness.
Arivale reports on biological markers identified in blood and saliva from clinical laboratory tests ordered and reviewed by an external physician. We focus on those markers with established clinical significance and, in some cases, biological markers for which there is substantial, though not yet conclusive, scientific evidence to suggest healthy lifestyle choices may reduce the risk or impact of well understood chronic disease and conditions and/or may help optimize your wellness.
Arivale reports on the microbiome diversity of your gut bacteria identified by clinical laboratory tests of your stool sample.
The science in this area is exciting, but still evolving. There is little scientists definitively know about your microbiome’s associations to other wellness markers and the overall significance of your microbiome’s bacterial diversity to health and wellness. While we will report data on your
gut bacteria’s diversity and relative abundance, the findings and recommendations from the clinical laboratory report should be viewed as inconclusive and subject to further scientific investigation and clinical development.
Arivale asks each program participant to complete a health assessment questionnaire included in the Program registration forms and also to wear a device that tracks exercise and sleep
so that the Arivale team may identify and better understand certain lifestyle factors that may beneficially contribute or otherwise diminish participant success in the program, The Lifestyle modification recommendations from your Arivale Coach are based on clinical outcomes or a substantial, but not yet conclusive, body of scientific evidence.