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Oncoguide ncc oncopanel system

Manufactured by Sysmex
Sourced in Japan

The OncoGuide NCC Oncopanel System is a comprehensive genomic profiling platform designed for cancer diagnostics. It utilizes next-generation sequencing technology to analyze multiple cancer-related genes simultaneously. The core function of this system is to provide detailed genetic information about a patient's tumor, which can assist healthcare professionals in making informed treatment decisions.

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7 protocols using oncoguide ncc oncopanel system

1

Advanced BTC CGP Observational Study

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This study is a prospective multicenter observational study of CGP in patients with advanced BTC. All relevant institutional ethics review boards approved this study (312–64), which was performed according to the provisions of the Declaration of Helsinki. Written consent was obtained from all patients. Seventy-two patients with advanced BTC underwent CGP, paid for by public health insurance, using FoundationOne® CDx genome profiling (F1CDx; Chugai Pharmaceutical, Tokyo, Japan), FoundationOne® Liquid CDx genome profiling (F1LCDx; Chugai Pharmaceutical), and an OncoGuide™ NCC Oncopanel System (NCC Oncopanel, Sysmex Corporation, Kobe, Japan). Patients were recruited between August 2019 and January 2022. Clinical data, including OS and demographic information, were collected from medical records and patient interviews.
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2

Comprehensive Genomic Profiling in Japan

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We include CGP tests that were covered by National Health Insurance in Japan. At first, these were three CGP tests that were covered by National Health Insurance: OncoGuide NCC Oncopanel System (Sysmex Corporation), FoundationOne® CDx Cancer Genomic Profile (Chugai Pharmaceutical), and FoundationOne® Liquid CDx Cancer Genomic Profile (Chugai Pharmaceutical). Some other CGP tests were additionally covered by this insurance and therefore we then added these new CGP tests by revising the protocol.
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3

EGFR mutation detection methods

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The diagnosis of EGFR mutation including exon 20 insertion was performed based on PCR-based methods (therascreen EGFR RGQ PCR Kit [Scorpion-ARMS technology]; QIAGEN, Hilden, Germany, and Cobas EGFR Mutation Test v2; Roche Diagnostics, Basel, Switzerland)21 (link),22 (link) and next-generation sequencing (NGS) testing (OncoGuide NCC Oncopanel System, Sysmex, Kobe, Japan)23 (link).
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4

Comprehensive Genomic Profiling Protocol

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Genomic data were also collected for patients who underwent tissue-based next-generation sequencing (NGS)-targeted gene panel analysis (FoundationOne® CDx [Chugai, Japan], or OncoGuide™ NCC Oncopanel System [Sysmex, Japan]).
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5

Comprehensive Genomic Profiling for Cancer

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CGP testing was performed using hybrid capture-based targeted DNA sequencing with FoundationOne CDx (Foundation Medicine), the OncoGuide NCC Oncopanel System (Sysmex Corporation), in-house NGS testing, or in blood-derived cell-free DNA with FoundationOne Liquid CDx (Foundation Medicine) or Guardant360 CDx (Guardant Health).4 (link),25 (link),26 (link),27 (link) All patients were referred to the NCCH following discussion by regional molecular tumor boards (MTB) comprising medical oncologists, pediatric oncologists, pathologists, bioinformaticians, genome researchers, and genetic counselors.3 (link),28 (link) In addition to reports from the inspection companies, the MTBs used reports containing clinical annotation and information regarding genotype-matched clinical trials from the Center for Cancer Genomics and Advanced Therapeutics national database.29 (link),30 (link)
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6

BELIEVE Trial: Expanded Access to CGP-Guided Therapy

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It is a requirement that the CGPs used in this study are covered by the National Health Insurance or are conducted as AMCs (Fig. 1). Two CGPs, namely the OncoGuide™ NCC Oncopanel System (Sysmex Corporation) and the FoundationOne® CDx Cancer Genomic Profile (Chugai Pharmaceutical), are currently covered by the National Health Insurance as CGP tests. Tests performed under the AMC category, including the Todai Onco Panel and Oncomine™ Target Test System, were also eligible for this study (as of September 2022).

Trial schema of the BELIEVE trial. a If a CGP test is performed and some off-label drug is recommended for the patient, the patient would originally be considered for participation in a clinical trial for drug approval already underway. However, if there are no such clinical trials, the patient would be eligible for the BELIEVE trial. b Patients would be treated at any of the Designated Cancer Genomic Medicine Core Hospitals if they participate in this trial. Pharmaceutical companies provide the medicines free of charge and will receive efficacy and safety data from the trial

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7

Evaluating EGFR Mutation Detection

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Common EGFR mutations, including exon 19 deletion and L858R mutation, were assessed using PCR-based methods (Therascreen EGFR RGQ PCR kit [Scorpion-ARMS technology]; QIAGEN, Hilden, Germany, and Cobas EGFR Mutation Test v2; Roche Diagnostics, Basel, Switzerland) and next-generation sequencing testing (Oncomine™ Dx Target Test; Life Technologies Corporation, Carlsbad, CA and OncoGuide NCC Oncopanel System; Sysmex, Kobe, Japan).
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