FDA Delays Finalization of Lab-Developed Test (LDT) Draft Guidance–An Opportunity to get forensic LDTs back on the table.

The laboratory developed test (LDT) pathway does not require proof of test validity, that the test is actually testing for what it claims to be testing, and with no FDA oversight a lab can claim an…

Source: FDA Delays Finalization of Lab-Developed Test (LDT) Draft Guidance–An Opportunity to get forensic LDTs back on the table.

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