Natera Announces Its Prospera Lung Test Has Met Coverage Requirements From The Centers For Medicare & Medicaid Services' Molecular Diagnostics Services Program For Single Lung Transplant Recipients; This Coverage Applies To SLT Patients In The...
Natera Announces Its Prospera Lung Test Has Met Coverage Requirements From The Centers For Medicare & Medicaid Services' Molecular Diagnostics Services Program For Single Lung Transplant Recipients; This Coverage Applies To SLT Patients In The...
Natera Announces Its Prospera Lung Test Has Met Coverage Requirements From The Centers For Medicare & Medicaid Services' Molecular Diagnostics Services Program For Single Lung Transplant Recipients; This Coverage Applies To SLT Patients In The Surveillance Setting.
Natera宣佈其Prospera肺部檢測已符合康哲藥業分子診斷服務項目對單側肺移植受體的覆蓋要求；此覆蓋適用於監測設置中的SLt患者。
Natera, Inc. (NASDAQ:NTRA), a global leader in cell-free DNA and genetic testing, today announced that its Prospera Lung test has met coverage requirements from the Centers for Medicare & Medicaid Services' (CMS) Molecular Diagnostics Services (MolDX) Program for single lung transplant (SLT) recipients. This coverage applies to SLT patients in the surveillance setting.
全球領先的電芯DNA和遺傳測試公司Natera, Inc.（納斯達克股票代碼：NTRA）今日宣佈，其Prospera肺部檢測已符合康哲藥業（CMS）分子診斷服務（MolDX）項目針對單側肺移植（SLT）受體的覆蓋要求。此覆蓋適用於監測設置中的SLt患者。
SLT patients make up ~20% of all U.S. lung transplants1. These patients are at an increased risk for acute rejection and also for complications from invasive procedures like biopsies due to common factors including advanced age, frailty, comorbidities, and functional dependency on a single lung. This creates an increased need for non-invasive monitoring solutions, like Prospera Lung.
單側肺移植（SLt）患者佔所有美國肺移植的約20%。這些患者由於包括高齡、虛弱、合併症和對單側肺功能依賴等常見因素，因此更容易出現急性排斥，以及由於侵入性檢查（如活檢）而產生併發症。這增加了對Prospera肺部等無創監測解決方案的需求。
The performance of Prospera Lung for SLT patients was published earlier this year from the Single Lung Allograft Monitoring (a.k.a. SLAM) study, the largest study of commercial donor-derived cell free DNA (dd-cfDNA) tests in SLT to-date. The data demonstrated excellent performance for Prospera in distinguishing rejection, infection, and chronic lung allograft disease (CLAD) from stable patients with an AUC-ROC of 0.85. These results are on par with Prospera's outstanding performance in double-lung transplants, and can ultimately provide confidence to rule out rejection, highlighted by a sensitivity of 77.8%, specificity of 84.6%, and a negative predictive value (NPV) of 96.8%.
今年早些時候發佈了Prospera肺部對SLt患者的表現，來源於單側肺移植監測（也稱爲SLAM）研究，這是迄今爲止商業供體來源細胞遊離DNA（dd-cfDNA）測試中最大的一項研究。數據表明，Prospera在區分排斥、感染和慢性肺移植物疾病（CLAD）與穩定患者方面表現出色，AUC-ROC爲0.85。這些結果與Prospera在雙側肺移植中的優異表現旗鼓相當，最終可提供排除排斥的信心，其77.8%的靈敏度、84.6%的特異度和96.8%的陰性預測值（NPV）突出顯示了這一點。
譯文內容由第三人軟體翻譯。
