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Mass-Spec Dx Makers Should Look To FDA's Multiplex, Multivariate Approach For Regulatory Tips

As FDA develops a framework for liquid chromatography-mass spectrometry diagnostics, the agency's previously circulated policies on multiplex test instrument systems and in vitro diagnostic multivariate index assays offer hints as to what LC-MS companies can expect.

While FDA is working on developing review guidances for liquid chromatography-mass spectrometry tests, LC-MS developers should look to the approach the agency has taken with similar devices, such as multiplex test systems and in vitro diagnostic multivariate index assays (IVDMIAs), for clues to how their products will be evaluated.

During a May 2 workshop at FDA's Maryland headquarters, officials heard from stakeholders about key statistical concerns with LC-MS tests, including validation standards and potential software requirements. But FDA did...

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