What's Going On With Colorectal Cancer Diagnostic-Focused Guardant Health Stock On Tuesday?
What's Going On With Colorectal Cancer Diagnostic-Focused Guardant Health Stock On Tuesday?
Tuesday, the FDA's staff reviewers raised concerns regarding Guardant Health Inc's (NASDAQ:GH) experimental blood test for colorectal cancer, suggesting it might not detect some tumor types that could become cancerous.
週二，美國食品藥品管理局的工作人員審查人員對Guardant Health Inc（納斯達克股票代碼：GH）的結直腸癌實驗血液檢查表示擔憂，這表明它可能無法檢測出某些可能變成癌性的腫瘤類型。
Guardant Health is seeking approval for Shield, a blood-based colorectal cancer (CRC) screening test for average-risk adults.
Guardant Health正在尋求批准Shield，這是一項針對中等風險成年人的血液結直腸癌（CRC）篩查測試。
Shield is an in vitro diagnostic device intended for the qualitative detection of CRC through sequencing the cell-free DNA (cfDNA) isolated from whole blood.
Shield是一種體外診斷設備，旨在通過對從全血中分離的無細胞DNA（cfDNA）進行測序，對結直腸癌進行定性檢測。
Related: Cancer Test Focused Guardant Health Stock Falls On FDA AdCom Update For Colorectal Test.
相關： 由於FDA AdCom的結直腸檢查更新，以癌症測試爲重點的Guardant Health股票下跌。
The FDA document noted, "Patients with advanced neoplasia (AA) have a high risk of developing CRC cancer. The Guardant ECLIPSE study demonstrated 83.1% sensitivity for CRC but only 13.2% sensitivity for the detection of AA."
美國食品藥品管理局的文件指出：“晚期腫瘤（AA）患者患結直腸癌的風險很高。Guardant ECLIPSE的研究表明，結直腸癌的靈敏度爲83.1％，但AA檢測的靈敏度僅爲13.2％。”
The FDA's Molecular and Clinical Genetics Panel is scheduled to meet on Thursday, 23 May, to review the premarket approval application for the company's Shield blood test for colorectal cancer screening.
美國食品藥品管理局的分子和臨床遺傳學小組定於5月23日星期四舉行會議，審查該公司用於結直腸癌篩查的Shield血液檢查的上市前批准申請。
Despite this, the reviewers acknowledged the test's potential benefits, noting that it could improve compliance with colorectal cancer screenings and aid in early detection, potentially curing patients and extending survival rates.
儘管如此，審查人員還是承認了該測試的潛在益處，指出它可以提高結直腸癌篩查的依從性，並有助於早期發現，有可能治癒患者並延長存活率。
If approved, Guardant's Shield test could become the second blood-based colorectal cancer test available in the United States.
如果獲得批准，Guardant's Shield測試可能成爲美國第二種基於血液的結直腸癌檢測。
Colorectal cancer affects approximately 150,000 people in the U.S. annually and is the second-leading cause of cancer deaths in the country, claiming over 50,000 lives each year.
結直腸癌每年影響美國約15萬人，是美國第二大癌症死亡原因，每年奪走50,000多人的生命。
The screening market for colorectal cancer in the U.S. is valued at nearly $20 billion.
美國結直腸癌篩查市場價值近200億美元。
Despite advancements, about 60 million people, or 50%, remain unscreened, Reuters noted, citing TD Cowen analyst.
路透社援引道明考恩分析師的話指出，儘管取得了進展，但仍有約6000萬人（佔50％）未接受篩選。
The U.S. Centers for Medicare and Medicaid Services (CMS) has stated it would reimburse blood-based biomarker colorectal cancer tests that show a minimum sensitivity of 74%, pending FDA approval.
美國醫療保險和醫療補助服務中心（CMS）表示，在等待美國食品藥品管理局批准之前，它將報銷最低靈敏度爲74％的血液生物標誌物結直腸癌檢測。
In contrast, the first blood biomarker test for colorectal cancer, Epigenomics' Epi proColon, was approved by the FDA in 2016 but was not reimbursed by the CMS in 2021 due to its 68.2% sensitivity.
相比之下，第一項結直腸癌血液生物標誌物測試——Epi ProColon於2016年獲得美國食品藥品管理局的批准，但由於其靈敏度爲68.2％，CMS在2021年沒有報銷。
Epigenomics, now owned by New Day Diagnostics and rebranded as ColoHealth, highlights the competitive landscape for Guardant's Shield as it seeks approval and potential market entry.
Epigenomics現歸New Day Diagnostics所有，更名爲ColoHealth，它突顯了Guardant's Shield在尋求批准和潛在市場進入方面的競爭格局。
Price Action: GH shares are down 2.62% at $24.12 at last check Tuesday.
價格走勢：週二最後一次檢查時，GH股價下跌2.62％，至24.12美元。
Image by PDPics from Pixabay
圖片由來自 Pixabay 的 PDPics
譯文內容由第三人軟體翻譯。