Devices

Study Looks at FDA Regulation of Laboratory-Developed Tests

Massachusetts General Hospital researchers say deviations in FDA policy during the Covid-19 pandemic may offer a blueprint for regulatory oversight of laboratory-developed tests (LDTs). The study was published in the Journal of Molecular Diagnostics.

A hospital news release says that during the pandemic, FDA (1) required makers of LDTs to submit validation data to enable assessment of assay performance and accuracy, and later (2) required makers of LDTs that received emergency use authorizations (EUAs) and makers of manufactured tests to validate their products’ accuracy by running them on a reference panel that served as a gold standard for detecting Covid-19.

The researchers analyzed the impact of the two FDA policy deviations and found that:

despite concerns that FDA wasn’t responding fast enough, a timeline of the initial 14 tests to receive EUAs showed that the process took 17 days on average from submission to authorization;
validating a test’s accuracy with the agency’s reference panel cost developers between $1,800 and $7,800; and
in vitro diagnostic tests for Covid-19 were not as sensitive as their makers initially reported.

What the FDA study did not measure, the researchers say, is how well manufacturers’ tests performed in the real world in hospital pathology labs. They say there currently are no tools to assess this performance systematically.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome