RegulatoryCompany release

FDA approves Labcorp's PGDx elio tissue complete CDx for advanced melanoma

🇺🇸 Labcorp Holdings Inc. (LH) · Wed 28 Oct 2026

Labcorp says the US regulator has approved its PGDx elio tissue complete test as a companion diagnostic to help identify patients with advanced melanoma.

Labcorp Holdings has reported that the US Food and Drug Administration approved its PGDx elio tissue complete CDx as a companion diagnostic to help identify patients with advanced melanoma. The company disclosed the approval in its third-quarter 2026 results, dated 28 October 2026.

The announcement was part of a broader results release. Labcorp also said it launched the FDA-cleared Elecsys pTau-217 Alzheimer's blood test after the end of the quarter.

The company further listed three pending acquisitions that depend on regulatory approvals, and said it had raised its full-year guidance. The summary available does not give details of the deals, the guidance figures, or the therapy for which the melanoma test is intended to select patients.

As general context, a companion diagnostic is a test whose use is considered essential for the safe and effective use of a corresponding medicine, and regulators typically review the test alongside the therapeutic.

What it means for your team

  • Regulatory teams working on melanoma therapies should check whether the new approval affects biomarker testing strategies, as the available information does not name a linked drug.
  • Quality and laboratory teams should note the approval of another companion diagnostic from a large US laboratory network.
  • Market-access teams should watch for labelling and testing-pathway details, which are not given in the results summary.
  • The three pending Labcorp acquisitions are subject to regulatory approvals; further details were not available.

Company's press release (SEC filing): Labcorp Holdings Inc. ↗

Article written by VigiEye from the official source (Labcorp Holdings Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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