2021 年 9 月 22 日肝癌的血液檢測顯示出希望

StephenW

肝癌的血液檢測顯示出希望2021 年 9 月 22 日彼得·維爾溫使用 DNA 甲基化生物標誌物的 Exact Sciences 測試比甲胎蛋白更敏感。與許多癌症一樣，早期發現肝細胞癌（最常見的肝癌類型）可以提高治愈性治療的機會。目前的指南建議，一些肝癌高危人群——肝硬化患者和一些乙型肝炎病毒攜帶者——應通過肝臟超聲檢查可能的疾病跡象。血液中甲胎蛋白水平的測試也可能被要求進行高水平的檢測，這可能表明肝細胞癌。但是這種治療肝細胞癌的方法有缺點，包括敏感性相對較低——檢測漏掉了存在的癌症。Exact Sciences 開發了 Cologuard，一種檢測糞便中結腸癌 DNA 標誌物的測試，開發了一種肝細胞癌的血液檢測，這取決於三種甲基化生物標誌物與甲胎蛋白的結合。在本月早些時候發表在《臨床胃腸病學和肝病學》上的一項研究中，由印第安納大學醫學院的 Naga P. Chalasani 領導的一組研究人員報告的研究結果表明，精確科學測試的總體敏感性為 88%，而敏感性為 58%。 % 用於甲胎蛋白測試。早期疾病的敏感性差異甚至更大（82% 對 40%）。然而，甲胎蛋白測試比 Exact Sciences 測試更具特異性（100% 對 87%），這可能意味著 Exact Sciences 測試的假陽性率更高Exact Sciences 以 Oncoguard 肝臟檢測（或溶液）的名義銷售該檢測。在研究論文中，它被稱為多目標 HCC 血液檢測 (mt-HBT)。 Exact Sciences 資助了這項研究，儘管作者有獨立性的保證。“mt-HBT 可以顯著改善接受 HCC 監測的患者的早期 HCC（肝細胞癌）檢測，這是增加治愈性治療機會和降低死亡率的關鍵一步，”發表在《臨床胃腸病學》和肝病學。在 DNA 甲基化中，甲基“粘”在 DNA 上並影響哪些基因表達為蛋白質。 Exact Sciences 肝癌檢測結合了來自三個甲基化標誌物（HOXA1、TSPYL5 和參考標誌物 B3GALT6）的信息，這是一種對甲胎蛋白和患者性別的檢測。Chalasani 和他的同事報告了臨床胃腸病學和肝病學兩個研究項目的結果。第一個涉及開發測試算法，第二個在一組 156 個肝細胞病例和一個 245 個對照組中對其進行驗證。 驗證研究，該測試的整體靈敏度為 88%，早期靈敏度為 82% -state 肝細胞癌，特異性為 87%

StephenW

Blood Test for Liver Cancer Shows Promise
September 22, 2021
Peter Wehrwein

Exact Sciences test that uses DNA methylation biomarkers is more sensitive than alpha-fetoprotein.

As with many cancers, early detection of hepatocellular carcinoma, the most common type of liver cancer, improves the chances for curative treatment. Current guidelines recommend that some people at high risk of developing liver cancer — those with cirrhosis and some hepatitis B virus carriers — be screened for possible signs of the disease with ultrasounds of the liver. Tests alpha-fetoprotein levels in the blood may also be ordered with a high level possibly indicative of hepatocellular carcinoma.

But this approach to hepatocellular carcinoma has shortcomings, including relatively low sensitivity — the tests miss cancer that is present.

Exact Sciences, which developed Cologuard, the test that detects colon cancer DNA markers in stool, has developed a blood test for hepatocellular carcinoma, that depends on three methylation biomarkers in combination in with alpha-fetaprotein.

In a study published earlier this month in Clinical Gastroenterology and Hepatology, a team of researchers led by Naga P. Chalasani of Indiana University School of Medicine reported findings that showed that the Exact Sciences test had overall sensitivity of 88% compared with a sensitivity of 58% for an alpha-fetaprotein test. The difference in sensitivity was even greater for early-stage disease (82% vs. 40%). However, the alpha-fetaprotein test was more specific than the Exact Sciences test (100% vs, 87%), which could mean more false positives with the Exact Sciences test

Exact Sciences is selling the test under name Oncoguard Liver test (or solution). In the research paper, it was called multitarget HCC blood test (mt-HBT). Exact Sciences funded the study, although the authors had guarantees of independence.

“The mt-HBT may significantly improve early-stage HCC (hepatocellular carcinoma) detection for patients undergoing HCC surveillance, a critical step to increasing curative treatment opportunities and reducing mortality,” reads the conclusion of the abstract of the study published in Clinical Gastroenterology and Hepatology.

In DNA methylation, a methyl group “sticks” to the DNA and affects which genes get expressed into protein. The Exact Sciences liver cancer test combines information from three methylation markers (HOXA1, TSPYL5, and a reference marker, B3GALT6), a test for alpha-fetaprotein and the patient’s sex.

Chalasani and his colleagues reported the results of two research projects in Clinical Gastroenterology and Hepatology. The first involved developing an algorithm of the test, the second validating it in a group of 156 hepatocellular cases and a control group of 245. The validation study, the test had an overall sensitivity of 88%, a sensitivity of 82% in the early-state hepatocellular carcinoma, and a specificity of 87%.