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# AMP Hits FDA Zika Test Enforcement
- URL: https://www.fdaweb.com/amp-hits-fda-zika-test-enforcement/
- Published: 2016-03-16T12:00:00.000Z
- Updated: 2026-09-15T02:44:35.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135099

> The Association for Molecular Pathology (AMP) says it is “concerned and disappointed” over FDA [enforcement action](https://www.fdaweb.com/cdrh-steps-up-enforcement-against-zika-tests/) against doctors at two Texas hospitals for their laboratory-developed test for the Zika virus. “Given the ongoing outbreak of the infection in the Houston area, these types of tests are critical for patient care and should be made available to those patients in need,” AMP says in a [statement](http://www.amp.org/emailads/AMPPressRelease031416.html?ref=fdaweb.com).  
>  
> The association says the agency action “is another clear example of how FDA regulation of laboratory-developed procedures would hinder patient access to vital medical services. FDA’s Emergency Use Authorization for antibody testing at the Centers for Disease Control or state public health labs will not provide results in the timely fashion needed for immediate patient care. In addition, antibody testing has limitations mitigated by molecular testing for Zika. Accurate, timely diagnosis and direct patient care is the primary mission of the molecular pathology professionals at Texas Children’s and Houston Methodist hospitals and other medical centers throughout the country.”