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Supporting the Precision Medicine Initiative: The All of Us Research Program

Posted by Christine Happel, Ph.D on Feb 14, 2018 10:00:00 AM

In 2015, President Obama announced the Precision Medicine Initiative, a new effort to revolutionize health and disease treatment.1 Two key components of this initiative are:

The overall mission of the All of Us Research Program is to develop a voluntary national research cohort of a million or more volunteers to propel our understanding of health and disease.2 The All of Us Program is set to be a patient-propelled, data-driven research program at the juncture of human biology, behavior, genetics, environment, and data science. It will examine the intersection of genes, environment and lifestyle in this large research cohort and have the statistical power to detect associations between environment and/or biological exposures and health outcomes.

Participants will provide urine and blood samples to undergo DNA genomic analysis. This analysis will include genome sequencing in a CLIA-certified laboratory. Participants will also provide additional details on lifestyle factors such as sleep, exercise and diet. This study is set to run for 10 years and will seek to enroll a diverse set of participants, including those that have been historically under-represented in scientific research. The All of Us Research Program is set to launch nationally in the spring of 2018. This program will create a valuable genomics data set of genomic variation for all stakeholders, including participants.

The All of Us Research Program is a collaboration across multiple sectors in an effort to forge partnerships to drive innovation and deliver clinical applications and solutions. The participation of Thermo Fisher Scientific’s CSO, Alan Sachs, in the 2017 Precision Medicine Leaders Summit and Thermo Fisher Scientific’s Head of Precision Medicine, Corina Shtir, at the Big Data Executive Summit: All About Us: Getting Personal with Precision Medicine & Oncology demonstrate the commitment to advancing precision medicine.3-5

Major medical breakthroughs in precision medicine have already led to new discoveries and diagnostic tests. The Oncomine DX Target Test is an in vitro diagnostic test that can detect sequence variation in 23 genes. It is used as a companion diagnostic to recommend one of three treatment options for non-small cell lung cancer. But this is just the beginning; the 20 additional gene variants could potentially correspond to future FDA-approved therapies.

The All of Us study anticipates generating massive amounts of data that could be used in future diagnostic tests and targeted therapies. A focus on integrating large amounts of precision medicine-related data with an eye toward clinical utility will change the future of healthcare.  You can find more information about the All of Us Research Program at https://allofus.nih.gov/.

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Bibliography

  1.        The White House. “President Obama’s Precision Medicine Initiative”. Fact sheet. 30 January 2015. https://obamawhitehouse.archives.gov/the-press-office/2015/01/30/fact-sheet-president-obama-s-precision-medicine-initiative
  2.        All of Us Research Program. https://allofus.nih.gov/
  3.        Thermo Fisher Scientific. ‘Precision Medicine Summit”. 2017. http://corporate.thermofisher.com/en/about-us/advancing-precision-medicine/precision-medicine-summit.html
  4.        Thermo Fisher Scientific. “Smarter Data Analysis in Precision Medicine is a Bridge to Clinical Utility”. 2017. http://corporate.thermofisher.com/en/about-us/advancing-precision-medicine/smarter-data-analysis-precision-medicine-bridge-clinical-utility.html
  5.        Precision Medicine Leaders Summit. https://www.precisionmedicineleaderssummit.com/