TAG:
orthogonal testing
Technical Assessment Challenges for Z-Code Applications
CEO SUMMARY: Effective on Aug. 1, UnitedHealthcare will require Z-code submissions for many genetic tests. During a recent webinar, experts tackled a topic that may prove troublesome for labs seeking Z-codes: technical assessments. Key advice is to provide specific data about clin…
CURRENT ISSUE
Volume XXXI, No. 16 – November 25, 2024
Two different federal lawsuits that challenge the authority of the federal Food and Drug Administration (FDA) to regulate laboratory developed tests (LDTs) will be combined. Plaintiffs and the government in both cases agreed to move forward on this basis.
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