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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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As proposed, the President’s Precision Medicine Initiative would incorporate a large, volunteer study cohort in innovative ways

Even as a new presidential initiative to boost precision medicine makes headlines, there is uncertainty as to how the program can be funded. The Precision Medicine Initiative was announced by President Obama on January 30, 2015.

Many pathologists, clinical chemists, and medical laboratory scientists recognize that such a program would pump additional funds into the research and development of new diagnostic tests that are designed to aid physicians in their practice of precision medicine.

The big question is how to pay for this initiative. President Obama proposed budgeting $215 million to fund this effort. But such funding must be approved by a Congress that is at odds with the President on nearly every issue. Additionally, The American Clinical Laboratory Association (ACLA) warns that the Food and Drug administration’s (FDA) 2014 announcement to regulate laboratory developed testing services (LDTs) is in conflict with the President’s initiative.

“The clinical laboratory community applauds the President’s leadership in the area of personalized medicine, particularly the new funding proposed for the National Institutes of Health (NIH) and National Cancer Institute (NCI),” said Alan Mertz, President of ACLA, in an ACLA press release.

“However, the FDA’s push to regulate laboratory developed testing services through the ‘Draft Guidance’ documents issued last year would dramatically slow patient access to vital diagnostic tools and runs counter to the President’s new initiative to promote precision medicine,” he continue. “Most of the new molecular and genetic diagnostic tests that are at the very heart of precision medicine are LDTs, and FDA’s proposal would severely impede the development of new LDTs and the advancement of precision medicine.”

Alan Mertz, President of ACLA

Alan Mertz, President of ACLA since 2003, is a leader on advocacy issues dealing with laboratory reimbursement, regulation, and coding. From 1998-2003, Mertz was Executive Vice President of the Healthcare Leadership Council (HLC) and served as Acting President at HLC for one year. From 1980 to 1998, he served in three senior staff positions in the House and Senate, and was selected as a John C. Stennis Congressional Fellow in 1996. Mertz was an adjunct professor at George Washington University from 1997-1999. He holds a Masters Degree in American Politics from American University and a BA in Government from Monmouth College (IL). (Photo and caption copyright the ACLA.)


Initiative Calls for Investing $215M in Mechanisms to Support New Research

Led by the National Institutes of Health (NIH), the President’s Initiative would fund research and facilitate collaborative public-private efforts to leverage advances in genomics. It would involve stakeholders in healthcare as well as the Food and Drug Administration (FDA), Health and Human Services (HHS), and the Office of the National Coordinator for Health Information Technology (ONC). It also would recruit expertise from multiple sectors and forge partnerships with existing research cohorts, patient groups, and the private sector to capitalize on previous genomic discoveries as well as work currently under way. The funding would get divided three ways:

The NIH would receive $130 million to:

  • Launch a national “patient-powered” research cohort consisting of scientists and a million volunteers,
  • Actively engage study participants in research,
  • Share research data with cohort members, and
  • Employ technological advances to mine health information for comprehensive results.

The FDA would receive $10 million to:

  • Acquire expertise to develop a new approach for evaluating next-generation sequencing technologies,
  • Determine which genetic changes are important to patient care,
  • Promote innovation in genetic sequencing technology,
  • Ensure test accuracy and reliability, and,
  • Advance the development of high quality, curated databases to support the regulatory structure.

The ONC would receive $5 million to:

  • Develop interoperability standards to ensure privacy during secure exchange of data across systems,
  • Empower patients and clinicians, and,
  • Advance individual, community, and population health.

The National Institute of Cancer (NIC) would receive $70 million to scale up efforts to identify genomic drivers in cancer, and then apply that knowledge to develop more effective cancer treatments. This would include:

  • Supporting expansion of genetically based clinical trials in partnership with drug companies,
  • Establishing a national “cancer knowledge network” that generates and shares new knowledge to fuel scientific discovery and guide treatment approaches,
  • Testing therapy combinations that target a tumor’s molecular structure,
  • Developing solutions to drug resistance,
  • Developing approaches to assessing therapy response and resistance, and,
  • Developing new tumor cell models to help clinicians predict response to drug combinations and define mechanisms of resistance.

Overall Goal Is to Apply Precision Knowledge to Patient Care

Volunteers in the study cohort would share their genomic profiles, biological specimens, and health and lifestyle data with the scientists by granting the researchers access to their electronic medical records (EHR).

Diagnostic tests and image studies would be available to the researchers, as well as lifestyle data, including diet, environmental exposures, and activity, which would be tracked by mobile health devices. Study volunteers, in turn, would assist in the designing of the studies, and have access to their own health and research data to help them make informed health choices.

This is an exciting development for pathologists and medical laboratory scientists. Many lab professionals will be called upon to develop new molecular diagnostic tests based on precision medicine research results, as well as genetic sequencing. The proposed funding for this initiative illustrates how whole-genome sequencing is poised to move into mainstream medicine. The question yet to be answered, however, is how quickly Congress might act to fund this initiative.

—Patricia Kirk

Additional Info:

FACT SHEET: President Obama’s Precision Medicine Initiative

Kalorama: White House Precision Medicine Initiative Spotlights Tissue Diagnostics

Precision Medicine Initiative

FDA Pushes Forward with Plans to Regulate Laboratory-Developed Tests, in a Move that Will Impact Many Clinical Laboratory Companies and Pathology Groups 

ACLA Lauds President’s Precision Medicine Initiative, Warns FDA Move to Regulate Laboratory Developed Tests (LDTs) Conflicts with White House Proposal