FDA授予Roche Elecsys GALAD评分突破性设备称号，以支持早期诊断

StephenW

FDA grants Breakthrough Device Designation for Roche's Elecsys GALAD score to support earlier diagnosis of hepatocellular carcinoma

• The Elecsys GALAD score aims to support clinicians in diagnosing hepatocellular carcinoma by giving them more timely and accurate information to make earlier interventions
• When hepatocellular carcinoma is detected and managed at the very earliest, patient’s 5-year survival rates can increase to over 70%1
• Utilizing blood-based biomarkers, as part of the Elecsys GALAD score, is minimally invasive to patients
  
  
  

Basel, 4 March 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the Elecsys® GALAD score.* This algorithmic score combines gender and age with the biomarker results of the Elecsys AFP, AFP-L3 and PIVKA-II and is intended to aid diagnosis of early stage hepatocellular carcinoma (HCC).

Dr. Amit Singal, Medical Director of the Liver Tumor Program  and Clinical Chief of Pathology at UT Southwestern Medical Center in Dallas, USA, stated, "HCC is the fourth leading cause of cancer-related death worldwide, with the highest burden of disease in East Asia and Africa. This high mortality is largely driven by most patients being detected at a late stage, when curative therapies are no longer possible. Therefore, improving early HCC detection is a critical area of need."
The Elecsys GALAD score will be the first GALAD score, with regulatory approval, for use in In Vitro Diagnostics and is an integral part of the Roche Diagnostics Liver Indication Program, which aims to improve diagnostic workflows throughout chronic liver disease management. Combined with ultrasound, the Elecsys GALAD score has the potential to support clinicians by giving them more accurate information at an earlier stage, thus improving patient outcomes while being minimally invasive for people and potentially also more affordable to healthcare systems.
Liver cancer is one of the few cancers that are on the rise.2 While recent developments in screening and new treatments are making advances in the prevention, diagnosis and treatment of HCC, clinicians still face challenges in diagnosing the disease early enough. Only 44% of liver cancer patients are diagnosed at an early stage.3 Of HCC patients, which are diagnosed with late-stage disease, less than 16% survive a period of 5 years. Of the patients diagnosed at an early stage, 70% percent are still alive after five years1. Therefore, diagnosing HCC, as early as possible, is essential to improving patient outcomes.

"We are excited about FDA’s recognition of the potential clinical benefit the Elecsys GALAD score could bring in diagnosing hepatocellular cancer at an early stage," said Thomas Schinecker, CEO of Roche Diagnostics. "The combination of blood-based biomarkers with clinical algorithms has the potential to significantly reduce mortality of HCC patients as they can receive a more timely diagnosis and treatment."

About GALAD Score
Pioneered by Professor Philip Johnson, Deputy Director of NWCR Centre and Professor in Translational Oncology at the University of Liverpool, and colleagues from the UK, the GALAD score is a serum biomarker-based model that predicts the probability of having hepatocellular carcinoma in patients with chronic liver disease. This combines gender and age with the results from assays AFP, AFP-L3 and PIVKA-II to give the clinician a clearer picture of HCC risk.

In chronic liver diseases, such as hepatitis and cirrhosis, Alpha1-fetoprotein (AFP) may be chronically elevated. Very high concentrations of AFP may be produced by certain tumors. This characteristic makes the AFP test useful as a tumor marker. AFP-L3 is a subtype of AFP and can be used to differentiate an increase in AFP due to HCC, or benign liver disease. PIVKA-II is a precursor and abnormal form of prothrombin that is found in patients with HCC. This can be used to differentiate HCC from non-HCC hepatic diseases.PIVKA-II is an alternate name for des-gamma-carboxy prothrombin (DCP).

About Hepatocellular Carcinoma
The American Association for the Study of Liver Diseases (AASLD) guidelines recommend surveillance of high risk populations for HCC, every 6 months using ultrasound, either with or without a blood test to check protein levels (AFP).4 Ultrasound examinations can be sensitive enough to detect small masses on the liver. While easily done in a doctor's office, ultrasound examinations are less conclusive with inexperienced technicians and in patients with obesity and fatty liver disease. A recent meta-analysis suggested that ultrasound may miss more than half of early stage HCCs.5 Therefore, other methods of diagnosis, such as abdominal CT scan, abdominal MRI scan or liver biopsy are often needed.4 These are more accurate than ultrasound, though are more invasive and uncomfortable for patients, as well as being costly to the healthcare system.

Liver cancer is one of the few cancers that are on the rise, and hepatocellular carcinoma (HCC), the primary type of liver cancer, accounts for 90% of these cases.6 Worldwide, the most common risk factor for HCC is viral hepatitis – known to cause inflammation of the liver.6,7 Chronic hepatitis B accounts for approximately 50% of all cases of HCC, and the majority of cases of childhood HCC.8 Other risk factors include aflatoxin – a carcinogenic mould found in contaminated foods, especially rice, in hot and humid climates.6

Viral hepatitis B has a particularly high prevalence in most countries in Asia, and this prevalence directly contributes to higher incidences of HCC in the region.7,9 An increasingly important risk factor for the development of HCC is non-alcoholic fatty liver disease (NAFLD), linked with fatty foods and obesity.10 This is the fastest-growing rate of any cancer and is thought to be driven in part by this risk factor, along with increased alcohol use.11

StephenW

FDA授予Roche Elecsys GALAD评分突破性设备称号，以支持早期诊断肝细胞癌

Elecsys GALAD评分旨在通过为临床医生提供更及时和准确的信息以进行早期干预来支持他们诊断肝细胞癌
最早发现并处理肝细胞癌后，患者的5年生存率可以提高到70％以上1
作为Elecsys GALAD分数的一部分，使用基于血液的生物标记物对患者的侵害微乎其微

2020年3月4日，巴塞尔，罗氏公司（六：RO，ROG； OTCQX：RHHBY）今天宣布，美国食品药品监督管理局（FDA）授予Elecsys®GALAD分数突破性设备称号。 *该算法评分将性别和年龄与Elecsys AFP，AFP-L3和PIVKA-II的生物标志物结果结合在一起，旨在帮助诊断早期肝细胞癌（HCC）。

美国达拉斯的UT西南医学中心肝脏肿瘤计划医学总监兼病理学临床主任Amit Singal博士说：“ HCC是全世界癌症相关死亡的第四大主要原因，其疾病负担最大。东亚和非洲。如此高的死亡率很大程度上是由于无法再进行治愈性治疗的大多数患者在晚期被发现而导致的。因此，改善早期肝癌的检测是至关重要的领域。”

Elecsys GALAD分数将是获得监管机构批准的首个GALAD分数，用于体外诊断，并且是Roche Diagnostics肝适应症计划的组成部分，该计划旨在改善整个慢性肝病管理中的诊断工作流程。与超声波相结合，Elecsys GALAD评分有可能在早期为临床医生提供更准确的信息，从而为他们提供支持，从而改善了患者的治疗效果，同时对患者的侵入性最小，并且对于医疗保健系统而言也更实惠。

肝癌是少数正在上升的癌症之一。 2尽管筛查和新疗法的最新发展在预防，诊断和治疗HCC方面取得了进步，但临床医生在尽早诊断该病方面仍面临挑战。早期诊断出只有44％的肝癌患者。 3名被诊断患有晚期疾病的HCC患者中，不到16％的患者可以存活5年。在早期诊断的患者中，有70％的患者在5年1后仍然存活。因此，尽早诊断HCC对于改善患者预后至关重要。

Roche Diagnostics首席执行官Thomas Schinecker表示：“ FDA对Elecsys GALAD评分可能在早期诊断肝细胞癌中获得潜在的临床益处感到非常高兴。” “基于血液的生物标记物与临床算法的结合具有显着降低HCC患者死亡率的潜力，因为他们可以得到更及时的诊断和治疗。”

关于GALAD分数
GALAD评分是利物浦大学NWCR中心副主任兼转化肿瘤学教授Philip Johnson以及英国同事的开创者，它是一种基于血清生物标记物的模型，可预测慢性肝癌患者发生肝癌的可能性肝病。这将性别和年龄与AFP，AFP-L3和PIVKA-II分析的结果结合在一起，使临床医生更清楚地了解HCC风险。

在诸如肝炎和肝硬化等慢性肝脏疾病中，甲胎蛋白（AFP）可能会长期升高。某些肿瘤可能产生很高浓度的AFP。该特征使得AFP测试可用作肿瘤标志物。 AFP-L3是AFP的一种亚型，可用于区分由于HCC或良性肝病引起的AFP升高。 PIVKA-II是凝血酶原的前体和异常形式，存在于HCC患者中。这可以用来区分HCC和非HCC肝病。PIVKA-II是des-γ-羧基凝血酶原（DCP）的别名。

关于肝细胞癌
美国肝病研究协会（AASLD）指南建议每6个月使用超声波对HCC高危人群进行监测，无论是否进行血液检查以检查蛋白水平（AFP）。 4超声检查可能足够灵敏以检测肝脏上的小块。尽管在医生办公室很容易进行超声检查，但是对于经验不足的技术人员以及肥胖症和脂肪肝患者来说，超声检查的结论性较差。最近的一项荟萃​​分析表明，超声可能会遗漏一半以上的早期肝癌。5因此，通常需要其他诊断方法，例如腹部CT扫描，腹部MRI扫描或肝活检。 4这些方法比超声检查更准确，但对患者而言更具侵入性且不舒服，并且对医疗保健系统而言成本很高。
肝癌是少数几种正在上升的癌症之一，肝细胞癌（HCC）是肝癌的主要类型，占这些病例的90％。6在世界范围内，HCC最常见的危险因素是病毒性肝炎– 已知会引起肝脏炎症。6,7慢性乙型肝炎约占所有HCC病例的50％，以及儿童期HCC的大多数病例。8其他危险因素包括黄曲霉毒素-在受污染的食物中发现的致癌菌，尤其是 大米，在炎热潮湿的气候中。6

乙型病毒性肝炎在亚洲大多数国家/地区特别流行，这种流行率直接导致该地区HCC的发生率更高。7,9非酒精性脂肪肝病（NAFLD）成为HCC日益重要的危险因素 ），与脂肪性食物和肥胖症有关.10这是所有癌症中增长最快的速度，并且被认为部分地受到该危险因素以及酒精使用量增加的驱动.11