Translation of a biomarker panel for the early detection of hepatocellular carcinoma
用于早期检测肝细胞癌的生物标志物组的翻译
基本信息
- 批准号:10020367
- 负责人:
- 金额:$ 51.89万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2019
- 资助国家:美国
- 起止时间:2019-09-18 至 2024-08-31
- 项目状态:已结题
- 来源:
- 关键词:AgeAlgorithmsAlkaline PhosphataseAreaAspartate TransaminaseBiological AssayBiological MarkersBlindedBloodBusinessesCase-Control StudiesCirrhosisClinicalClinical Laboratory Improvement AmendmentsClinical ManagementCollaborationsCollectionDataDetectionDiagnosisDiagnosticDiscriminationDiseaseEarly DiagnosisEvaluationGenderGeographic LocationsGlycoproteinsGoalsHistologyImageIndividualIndustrializationIndustryInfluentialsKininogensLaboratoriesLegal patentLesion by StageLinkLiver FibrosisLogistic RegressionsLow-Molecular-Weight KininogenMalignant Epithelial CellMalignant NeoplasmsMalignant neoplasm of liverMarketingMeasurementMedicalMedical centerMedicareMethodsModelingModificationPatient CarePatientsPerformancePhasePolysaccharidesPopulations at RiskPrimary carcinoma of the liver cellsProteinsReagentReceiver Operating CharacteristicsReproducibilityResearchRiskRunningSamplingSensitivity and SpecificitySerumSerum ProteinsServicesSiteSouth CarolinaSpecialistSupport SystemTechnologyTestingTexasTimeTranslatingTranslationsUltrasonographyUnited States Centers for Medicare and Medicaid ServicesUniversitiesValidationWorkalpha-Fetoproteinsbasebiomarker panelcancer diagnosiscase controlclinical Diagnosisclinical practiceclinically relevantcohortcommercializationdesignearly detection biomarkersglycosylationimprovedliver functionmultidisciplinarynovelnovel markerprospectiveregression algorithmsample collectiontesting servicestumorvalidation studies
项目摘要
This application proposes to translate our identification of a biomarker panel for hepatocellular carcinoma to
commercial and clinical use. We have identified a specific post-translation modification that is altered in HCC.
This alteration is a shift in the composition of N-linked glycans found on proteins made in and secreted by HCC
cells. Many of the proteins containing this glycan alteration have been identified and patented. Our strong
preliminary evidence has shown that some of these proteins, when combined with existing biomarkers and
clinical factors, have excellent discriminatory ability between those with HCC and those with cirrhosis.
Importantly, our biomarker efforts have focused on the detection of early stage lesions using our current
biomarker panel, which is a simple logistic regression algorithm composed of fucosylated kininogen, alpha-
fetoprotein (AFP), alkaline phosphatase (ALK), aspartate aminotransferase (AST), age and gender. Called the
kininogen panel, it had an area under the receiver operator curve (AUROC) of 0.97 for the differentiation of early
stage HCC from cirrhosis. In an independent external validation of this panel, in three independent cohorts this
panel had an AUROC of 0.92 to 0.97 in the detection of early stage HCC. Thus our enthusiasm for this biomarker
panel is high. To fully understand the clinical and commercial benefits of any biomarker, a large scale clinical
validation study that is appropriate powered is essential. Hence, the two goals of this application are to validate
the kininogen panel for the detection of early stage HCC at the time of HCC diagnosis (Aim 1) and determine
when in time an individual becomes biomarker positive prior to developing HCC (Aim 2). At the completion of
these two aims, Glycotest will have validated this biomarker panel and have confidence in its performance.
Glycotest's strategy is focused on commercialization of its tests as Laboratory Developed Test (LDT) service
products. These tests will be marketed to and ordered by specialists who care for the patient populations at risk
for liver cancers and fibrosis-cirrhosis. LDTs are tests developed and run in a single "CLIA lab" regulated by the
Center for Medicare & Medicaid Services (CMS) through the Clinical Laboratory Improvement Amendments
(CLIA). The LDT business model has been used successfully by many other US companies that have
commercialized tests as service products in multiple disease areas. The Company will establish an internal
selling and marketing capability focused initially on major influential medical centers and key opinion leader sites
as well as the west coast and east coast geographical areas, and will pursue a strategy for establishing Medicare
reimbursement that it has developed in collaboration with external experts.
本应用程序建议将我们对肝细胞癌生物标志物面板的鉴定转化为
项目成果
期刊论文数量(0)
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JORGE A MARRERO其他文献
JORGE A MARRERO的其他文献
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{{ truncateString('JORGE A MARRERO', 18)}}的其他基金
Translation of a biomarker panel for the early detection of hepatocellular carcinoma
用于早期检测肝细胞癌的生物标志物组的翻译
- 批准号:
10227998 - 财政年份:2019
- 资助金额:
$ 51.89万 - 项目类别:
Translation of a biomarker panel for the early detection of hepatocellular carcinoma
用于早期检测肝细胞癌的生物标志物组的翻译
- 批准号:
10686284 - 财政年份:2019
- 资助金额:
$ 51.89万 - 项目类别:
Translation of a biomarker panel for the early detection of hepatocellular carcinoma
用于早期检测肝细胞癌的生物标志物组的翻译
- 批准号:
10478012 - 财政年份:2019
- 资助金额:
$ 51.89万 - 项目类别:
Early Detection and Prognosis of Patients with Hepatocellular Carcinoma
肝细胞癌患者的早期检测和预后
- 批准号:
7361367 - 财政年份:2007
- 资助金额:
$ 51.89万 - 项目类别:
STUDY OF SORAFENIB IN PATIENTS WITH ADVANCED HEPATOCELLUL
索拉非尼治疗晚期肝细胞癌患者的研究
- 批准号:
7603805 - 财政年份:2007
- 资助金额:
$ 51.89万 - 项目类别:
Early Detection and Prognosis of Patients with Hepatocellular Carcinoma
肝细胞癌患者的早期检测和预后
- 批准号:
7240344 - 财政年份:2007
- 资助金额:
$ 51.89万 - 项目类别:
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