Improving Access to Point of Care Testing through Sound Science & Regulatory Reform

Point-of-care testing –- running a test where the patient and healthcare provider are located, as opposed to sending out patient specimens for analysis at off-site laboratories –- can save time, lives, and valuable healthcare dollars.  The majority of point-of-care testing in the US today is done at CLIA-waived laboratories, which represent nearly 70% of all laboratories in the United States.  By law, these laboratories must exclusively use tests that are assigned a "waived" (low) complexity rating by the U.S. Food and Drug Administration.

 

Unfortunately as a result issues with current regulation, both innovation of waived tests and access to novel diagnostic tests has been severely hindered.


Recent events have highlighted the need for further innovation and access.  The spread of infectious disease, such as Ebola has caught headlines.  The White House issued an Executive Order to expand and incentivize the development of point of care diagnostic tests.  However to truly see advancement of and access to testing that patients deserve, we must fix the underlying regulatory system that is holding CLIA-waived testing back.  Luckily, the fix is simple.

 

The Coalition for CLIA Waiver Reform is an organization dedicated to changing the regulatory process for obtaining CLIA Waivers so the full benefit of safe and effective CLIA-waived tests can be brought to patients.  We welcome everyone –- patients, doctors, associations, CLIA-waived labs, legislators, diagnostics companies, and other members of the public –- to join us in the quest for better better regulation in the interest of public health.  To find out more about what you can do please contact us.

WHO WE ARE

The Coalition for CLIA Waiver Reform is an organization dedicated to improving access to safe and effective diagnostic testing at the point-of-care by reforming the U.S. Food and Drug Administration's  CLIA Waiver Program.

MISSION

 

To bring together interested stakeholders from all quarters to press for a return to the principles of FDA's 2001 CLIA Waiver Guidance, which will expand access to CLIA-waived point-of-care testing for the benefit of patients.