Clinical utility of a blood based assay for the detection of IDH1 ...

(2021) studied the clinical utility of comprehensive genomic profiling to detect ... TERT Promoter Mutation Analysis for Blood-Based Diagnosis and ...

LCD - Biomarkers for Oncology (L35396) - CMS

While some biomarkers have utility for testing once per lifetime, there are some tumor specific scenarios where repeat testing would be needed for assessment of ...

4316 Measurable Residual IDH1 before Allogeneic Transplant for ...

... clinical outcome differences based on IDH1m persistence. ... Conclusion: Detection of persistent IDH1 variants in the blood of ...

Comprehensive clinical assays for molecular diagnostics of gliomas

Another possibility is to use blood for detecting ctDNA, however ... TERT promoter mutation analysis for blood-based diagnosis and monitoring of gliomas.

Clinical Practice Guideline for Blood-based Circulating Tumor DNA ...

... assay detection limit [10-13]. Therefore, to detect residual ... When requesting the test from an external laboratory, the use of ...

Molecular Diagnostics of Gliomas - Allen Press

Diagnostic use of IDH1/2 mutation analysis ... A pyrosequencing-based assay for the rapid detection of IDH1 mutations in clinical samples.

IDH1-IDH2 Mutation Detection | Test Fact Sheet - ARUP Consult

... clinical evaluation and genetic counseling should be considered before additional testing. ... Use to detect IDH1 and IDH2 mutations. References ...

Evaluation of the rapid Idylla IDH1-2 mutation assay in FFPE glioma ...

The Idylla assay can detect IDH1/2 mutational status from ... For example, recent studies demonstrated the clinical utility of ...

Idylla TM IDH1-2 Mutation Assay Kit - Biocartis

The fully automated Idylla™ IDH1-2 Mutation Assay Kit performs detection of 5 mutations in the isocitrate dehydrogenase 1 gene (IDH1) and 10 mutations in ...

IDH1/2 Mutation Detection Kit | EntroGen, Inc.

Kit Features. The IDH 1/2 assay is polymerase chain reaction (PCR)-based that detects somatic mutations in DNA isolated from blood or tissue in three ...

Nucleic Acid Based Tests | FDA

Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay, Illumina ... IC-GPC Assay for use on the IC-System (positive blood cultures) ...

Durable Remissions with Ivosidenib in IDH1-Mutated Relapsed or ...

IDH1 mutation status was based on prospective local laboratory testing ... Additional clinical benefits included the development of ...

Building the Evidence Base of Blood-Based Biomarkers for Early ...

... clinical validation to allow their use in combination for screening in the general population ... For early cancer detection, a blood-based ...

Circulating tumor DNA in advanced solid tumors

dated assay may support targeted therapy if clinical utility has been demonstrated for that biomarker when identified by tissue testing. Analyses of ctDNA ...

Caris Assure™ Liquid Biopsy - Caris Life Sciences

Clonal hematopoiesis (CH) mutations from aging white blood cells may cause false positive results in blood-based assays. Caris Assure distinguishes CH from ...

Clinical Evaluation of IDH Mutation Status in Formalin-Fixed Paraffin ...

A 1:3 dilution step was introduced into the IDH2 assay prior to testing to mimic the IDH1 assay protocol and normalize the specimen processing.

Evidence of Clinical Utility: An Unmet Need in Molecular Diagnostics ...

... laboratory setting, and to identify ... · Whether use of the assay improves clinical and health outcomes based on subsequent diagnosis and intervention.

Using Measurable Residual Disease to Optimize Management of ...

MRD may be detectable below the prognostic threshold but above the assay's limit of detection. ... It remains unknown whether blood-based MRD ...

Final Overall Survival Efficacy Results of Ivosidenib for Patients With ...

Findings In this phase 3 randomized clinical trial including 187 previously treated patients with advanced cholangiocarcinoma with IDH1 mutation ...

IDH1/2 RGQ PCR Kit - QIAGEN

Accurate detection of 7 IDH1 and 5 IDH2 mutations using PCR clamping · Sensitive identification of 3 mutations using ARMS PCR technology · A standardized assay ...