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

Point-of-care testing –- that is, 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, CLIA-waived laboratories are currently unable to test for many diseases and health conditions affecting patients.  The problem is not that tests do not exist – they do.  The problem is the current regulatory process for seeking CLIA waivers for novel diagnostics, a problem which has its roots in misinterpretation of law, and a lack of appreciation for the value that expanded CLIA-waived testing could provide to patients everywhere.

 

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.