Illumina, 20066472, TSO Comprehensive Enablement Services

Name: TSO Comprehensive Enablement Services
Brand: Illumina
SKU: 20066472

One-time required purchase that includes four days of hands-on training and workflow instruction (library prep, enrichment, sequencing, and data analysis) for up to two operators.

Catalog Number: 20066472

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Category

Hematology Analyzers

TagsIn vitro diagnostic (IVD) products

Description

Overview
TruSight Oncology Comprehensive is a US FDA-approved next-generation sequencing (NGS)-based CGP IVD for analyzing solid tumors using minimal tissue.
Detect DNA plus RNA variants along with biomarker signature TMB
Save time and money by assessing multiple biomarkers in a single test
Enable targeted therapies and clinical trials with actionable, easy-to-interpret results

Key biomarkers
Content includes key biomarkers associated with major US clinical guidelines, drug labels, and clinical trials.

Companion diagnostic
TruSight Oncology Comprehensive is intended to be used as a companion diagnostic to identify cancer patients who may benefit from treatment with the targeted therapies listed in the table within the intended use statement below, in accordance with the approved therapeutic product labeling.

In-house CGP
Rely on a distributed sample-to-answer solution that can be implemented in-house. Offer precision oncology locally and keep the data and sample in your institution, reducing the likelihood of quantity not sufficient (QNS) issues.

Intended use
TruSight Oncology Comprehensive is a qualitative in vitro diagnostic test that uses targeted next-generation sequencing to detect variants in 517 genes using nucleic acids extracted from formalin-fixed, paraffin embedded (FFPE) tumor tissue samples from cancer patients with solid malignant neoplasms using the Illumina NextSeq 550Dx instrument. The test can be used to detect single nucleotide variants, multi-nucleotide variants, insertions, and deletions from DNA, and fusions in 24 genes and splice variants in one gene from RNA. The test also reports a Tumor Mutational Burden (TMB) score.
The test is intended to be used as a companion diagnostic to identify cancer patients who may benefit from treatment with the targeted therapies listed in Table 1, in accordance with the approved therapeutic product labeling.
In addition, the test is intended to provide tumor profiling information for use by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Genomic findings other than those listed in Table 1 of the intended use statement are not conclusive or prescriptive for labeled use of any specific therapeutic product.
Table 1: Companion Diagnostics Indications
Tumor Type: Biomarker(s) Detected
Solid Tumors: NTRK 1/2/3 fusions
Non-Small Cell Lung Cancer: RET fusions

Applications
TruSight Oncology Comprehensive is an in vitro diagnostic test that generates a comprehensive genomic profile of a patient’s tumor, informing therapy decisions according to clinical guidelines.

Example workflow
TruSight Oncology Comprehensive
NextSeq 550Dx System
Local Run Manager TruSight Oncology Comprehensive Analysis Module (on-instrument software)

Related applications and methods
Comprehensive genomic profiling
This next-generation sequencing approach consolidates hundreds of cancer-related markers, including different variant types, into a single assay.
Oncology
Illumina NGS and microarray technologies for cancer research are helping drive the revolution in cancer genomics.

Fully automated sequencing and data analysis
Batch up to seven patient samples and two control samples per run. Library prep and enrichment take 2 days, followed by a fully automated workflow on the NextSeq 550Dx Instrument. The entire workflow takes 4–5 days.

Results report for TruSight Oncology Comprehensive
Reported cancer mutations categorized as cancer mutations with evidence of clinical significance or potential clinical significant based on an expertly curated knowledge base including clinical guidelines, drug labels, clinical trials, and peer-reviewed literature. Easy-to-read output helps increase confidence in treatment decisions.

Introducing TruSight Oncology Comprehensive
TruSight Oncology Comprehensive
20032573
TruSight Oncology Comprehensive kit contains library prep reagents, indexes and panel View less
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TruSight Oncology DNA Control
20065041
Includes a qualitative IVD control for monitoring analytical performance of library prep, sequencing, and analysis. View less
TruSight Oncology RNA Control
20065042
NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD
20028871
NextSeq 550Dx High Output Reagent Kit v2.5 (300 Cycles) is a set of reagents and consumables intended for sequencing of sample libraries when used with validated assays. The kit is intended for use with the NextSeq 550Dx instrument and analytical software. View less
NextSeq™ 550Dx Sequencing System
20005715
The NextSeq 550Dx instrument is intended for sequencing of DNA libraries when used with in vitro diagnostic assays performed on the instrument. The NextSeq 550Dx instrument is to be used with specific registered, certified or approved in vitro diagnostic reagents and analytical software.The instrument includes a dual boot configuration to enable the use of the instrument in either diagnostic (Dx) or research use only (RUO) mode. In vitro diagnostic sequencing assays, including the Germline and Somatic Variant Modules, are executed in diagnostic mode. Only IVD sequencing reagents can be utilized in diagnostic mode. View less
TSO Comprehensive Enablement Services
20066472
One-time required purchase that includes four days of hands-on training and workflow instruction (library prep, enrichment, sequencing, and data analysis) for up to two operators. View less
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How was TruSight Oncology Comprehensive validated?
The test was validated with more than 1400 unique FFPE samples and over 15 different tumor types. Results were compared to orthogonal methods to ensure accurate, reproducible, and consistent data.

What support does Illumina offer for TruSight Oncology Comprehensive?
Illumina offers a comprehensive support program that provides onboarding to expedite test verification, lab training, verification protocols, training certification, 24/5 technical support, support from our Medical Affairs team for medical inquiries, and educational and marketing assets to share with your local health care providers. Contact your local Illumina Account Manager for more details about the comprehensive support program.

How does reimbursement for TruSight Oncology Comprehensive work?
IVD CGP tumor profiling assays with companion diagnostic (CDx) claims across solid neoplasms are covered for eligible Medicare beneficiaries throughout the US under National Coverage Determination (NCD) 90.2. Commercial coverage for assays with this indication increases by more than a third of US commercially insured lives as compared to assays without CDx claims 1 . Illumina has established a dedicated Market Access team that is actively working with payers to further expand CGP test reimbursement across the globe. Contact your local Illumina Account Manager with questions about coverage.

What additional companion diagnostic (CDx) indications are under development?
Illumina has established multiple partnerships with pharma companies to develop a growing pipeline of CDx indications pending regulatory approvals, that include MSI (Bristol Myers Squibb) 2 , EGFR (Teligene) 4 , and TP53 (Kartos) 5 .

What is the FFPE input requirement for TruSight Oncology Comprehensive?
The minimum recommended tissue volume is 1 mm 3 with a minimum of 20% tumor cell content by area required to detect somatic driver mutations. A minimum of five biopsy slides is recommended (10 µm sections, 20 mm 2 tissue area each).

Interested in a product overview from one of our oncology specialists?
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References
Policy Reporter. Data pulled in 2023.
Illumina announces new and expanded oncology partnerships with Bristol Myers Squibb, Kura Oncology, Myriad Genetics, and Merck to advance comprehensive genomic profiling. https://www.businesswire.com/news/home/20210111005930/en/Illumina-Announces-New-and-Expanded-Oncology-Partnerships-with-Bristol-Myers-Squibb-Kura-Oncology-Myriad-Genetics-and-Merck-to-Advance-Comprehensive-Genomic-Profiling . Accessed July 24, 2023.
Illumina partners with Merck to develop and commercialize companion diagnostic and research tests for use in identifying specific cancer mutations. https://www.prnewswire.com/news-releases/illumina-partners-with-merck-to-develop-and-commercialize-companion-diagnostic-and-research-tests-for-use-in-identifying-specific-cancer-mutations-301369838.html . Accessed July 24, 2023.
Illumina and Taolue Biopharmaceuticals Collaborate to Help Chinese Innovation Go Global. https://www.illumina.com.cn/company/news-center/press-releases/2023/648d0d26-1f0a-4b65-b387-2c272761fbd711111.html
Illumina and Kartos Therapeutics Announce New Oncology Partnership to Develop an NGS-Based TP53 Companion Diagnostic. https://www.illumina.com/company/news-center/press-releases/2021/12b6e4a6-3f52-407e-8200-8fa72712a980.html

Specifications

General

Assay time	4-5 days
Hands-on time	~10.5 hr
Input quantity	40 ng genomic DNA and 40 ng total RNA
Content specifications	Covers clinically relevant biomarkers across multiple solid tumors included in 53 US clinical guidelines, 60 FDA drug labels, and 860+ US clinical trials. Panel content: 517 genes for small DNA variants, 24 genes for RNA fusions, 1 gene for RNA splice variants (EGFR), and TMB.
False positive rate by rna variant type	RNA Fusions: 0% RNA Splice Variants: 0%
RNA Fusions	0%
RNA Splice Variants	0%
False positives by dna variant type	Small DNA Variants: 0.0001% TMB: not applicable as no clinical threshold has been established.
Small DNA Variants	0.0001%
TMB	not applicable as no clinical threshold has been established.
Instruments	NextSeq 550Dx Instrument
Method	Targeted DNA sequencing , Targeted RNA sequencing , Target enrichment
Nucleic acid type	DNA, RNA
Sample throughput	Up to 7 patients and 2 controls (1 positive and 1 NTC) samples per sequencing run
Species category	Human

Ordering

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Unless otherwise stated, the minimum order amount is USD 1,000.
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