新一代伴隨診斷測試
Labcorp 旗下PGDx Elio Tissue Complete CDx獲批
Labcorp 是一家在診斷及藥物研發領域佔重要地位的全球實驗室服務公司，其 PGDx Elio Tissue Complete CDx 已獲美國食品藥品監督管理局批准——這是一款利用次世代定序技術，檢測晚期黑色素瘤患者腫瘤組織中特定 BRAF V600E 及 V600K 變異的伴隨診斷測試。這項創新旨在協助臨床醫生判斷哪些患者適合接受已獲 FDA 批准的 BRAF 抑制劑或 BRAF/MEK 抑制劑聯合療法。
黑色素瘤，尤其是第四期患者，五年存活率一直偏低，約為 16%，因此及時而準確的分子檢測對指導治療決策至關重要。Labcorp 的伴隨診斷測試透過提供一套標準化、可規模化的套件解決方案，直接應對這一需求，可於醫院及醫療系統內直接實施。
英文原文
Labcorp, a global laboratory services company with a significant presence in diagnostics and drug development, has received approval from the U.S. Food and Drug Administration for its PGDx Elio Tissue Complete CDx — a companion diagnostic test that uses next-generation sequencing to detect specific BRAF V600E and V600K variants in tumor tissue from patients with advanced melanoma. The goal of this innovation is to help clinicians determine which individuals may be eligible for treatment with FDA-approved BRAF inhibitors or BRAF/MEK inhibitor combination therapies.
Melanoma, particularly at stage IV, has a historically low five-year survival rate of approximately 16%, making timely and accurate molecular profiling critical for guiding treatment decisions. Labcorp's companion diagnostic test addresses that need by providing a standardized, scalable kit-based solution that can be implemented directly within hospitals and health systems.
- 來源
- Trend Hunter
- 發布
- 2026-08-14
- 品類
- Life
- 出處
- ir.labcorp