The first US FDA-approved distributable comprehensive genomic profiling (CGP) IVD with pan-cancer companion diagnostic (CDx) claims.
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TruSight Oncology Comprehensive is a US FDA-approved next-generation sequencing (NGS)-based CGP IVD for analyzing solid tumors using minimal tissue.
Content includes key biomarkers associated with major US clinical guidelines, drug labels, and clinical trials.
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.
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.
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 | Therapy |
|---|---|---|
| Solid Tumors | NTRK 1/2/3 fusions | VITRAKVI® (larotrectinib) |
| Non-Small Cell Lung Cancer | RET fusions | RETEVMO® (selpercatinib) |
| Assay time | 4-5 days |
|---|---|
| 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 |
|
| False positives by dna variant type |
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| Hands-on time | ~10.5 hr |
| Input quantity | 40 ng genomic DNA and 40 ng total RNA |
| 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 |
| Technology | Sequencing |
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.
TruSight Oncology Comprehensive
Local Run Manager TruSight Oncology Comprehensive Analysis Module (on-instrument software)
Comprehensive genomic profiling
This next-generation sequencing approach consolidates hundreds of cancer-related markers, including different variant types, into a single assay.
Illumina NGS and microarray technologies for cancer research are helping drive the revolution in cancer genomics.
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.
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.
| Pan-cancer: BRAF, NTRK1, NTRK2, NTRK3, RET, TMB | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Genes with biomarkers of clinical significance a | Genes with biomarkers of potential clinical significance b | ||||||||||
 Breast |
AKT1 | BRCA1 | BRCA2 | ERBB2c | ESR1 | PALB2 | PIK3CA | PTEN | 104 | ||
 Colorectal |
ERBB2c | KRAS | NRAS | 157 | |||||||
 Bone |
EGFR | ERG | ETV1 | ETV4 | EWSR1 | FEV | FLI1 | FUS | IDH1 | 109 | |
 Lung |
ALKc | EGFR | ERBB2c | KRAS | METc | NUTM1c | ROS1c | 126 | |||
 Melanoma |
KIT | NRAS | ROS1c | 116 | |||||||
 Ovarian |
BRCA1 | BRCA2 | ERBB2c | 109 | |||||||
 CNS d |
ATRX | CDKN2A | CDKN2B | EGFR | H3F3A | HIST1H3B | HIST1H3C | IDH1 | IDH2 | MYCN | 69 |
| NF1 | PTCH1 | TERT | TP53 | ||||||||
 Prostate |
ATM | ATR | BARD1 | BRCA1 | BRCA2 | BRIP1 | CDK12 | CHEK1 | CHEK2 | FANCA | 101 |
| FANCL | FGFR3 | MLH1 | MRE11 | NBN | PALB2 | PTEN | RAD51B | RAD51C | RAD51D | ||
| RAD54L | TACC3 | ||||||||||
 Thyroid |
TERT | 111 | |||||||||
 Uterine & cervical |
BRCA2 | ERBB2c | ESR1 | FOXO1 | GREB1 | NCOA2 | NCOA3 | PAX3 | PAX7 | POLE | 130 |
| SMARCA4 | TP53 | ||||||||||
Genes listed represent a subset of genes present in the TruSight Oncology Comprehensive panel. Content analysis provided by Velsera based on IVD software Knowledge Base v8.17 (March 2024).
TruSight Oncology Comprehensive
20032573
TruSight Oncology Comprehensive kit contains library prep reagents, indexes and panel
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TruSight Oncology DNA Control
20065041
Includes a qualitative IVD control for monitoring analytical performance of library prep, sequencing, and analysis.
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TruSight Oncology RNA Control
20065042
Includes a qualitative IVD control for monitoring analytical performance of library prep, sequencing, and analysis.
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NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD
20028871
Includes one high output flow cell, one buffer cartridge, and one reagent cartridge containing clustering and sequencing reagents to support a 300-cycle run on the NextSeq 550Dx System. All products registered for In Vitro Diagnostic sequencing.
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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.
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.
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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.
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.
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 claims1. 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.
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.
The minimum recommended tissue volume is 1 mm3 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 mm2 tissue area each).
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Order a NextSeq 550Dx Instrument today. Speak to a representative for information on pricing, availability, and more.
These sequencing reagent kits offer a simplified workflow and high data quality for in vitro diagnostic testing on the NextSeq550 Dx Instrument.
The first CE-marked IVD kitted solution for comprehensive genomic profiling (CGP) of DNA and RNA variants, plus MSI and TMB, for multiple solid tumor types.
Order a NextSeq 550Dx Instrument today. Speak to a representative for information on pricing, availability, and more.
These sequencing reagent kits offer a simplified workflow and high data quality for in vitro diagnostic testing on the NextSeq550 Dx Instrument.
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