Precise™ Tumor
Molecular Profile Testing

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Precise™ Tumor
Molecular Profile Testing

Order a test kit

Product Overview

Precise™ Tumor† is a next-generation sequencing (NGS) assay with hybrid capture model consisting of DNA- and RNA-based testing which detects Single-Nucleotide Variants (SNV), Insertion-Deletion Mutations (INDELs), Copy Number Variants (CNV), and fusions in solid tumors.

You can download additional resources for Precise Tumor HERE

Using tumor testing procedures you are familiar with in an innovative and comprehensive way, Precise Tumor testing will allow you to save time, gain confidence, and arm yourself with the information you need to help your patients. Also included in Precise Tumor testing is optional enrollment in our treatment registry.

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Product Features

Actionable: 500+ solid tumor-related genes with broad coverage of key guidelines and clinical trials for multiple solid tumor types.

Key Immuno-oncology biomarkers:

  • Microsatellite Instability (MSI)
  • Tumor Mutational Burden (TMB)
  • Programmed Death-Ligand 1 (PD-L1), if requested.

Clinically Validated and Comprehensive genomic coverage necessary for accurate selection of FDA-approved targeted and immunotherapy (IO), biomarkers while also evaluating, while also evaluating many genes relevant to early phase drug development efforts that may have future clinical applications in all solid tumors1.

Accurate: Sensitivity: 98.91% Specificity >99.99% using orthogonal methods, including DNA- and RNA-based next generation targeted exome sequencing with full coverage of all exons. Accurately measures TMB, microsatellite instability, SNVs, indels, copy-number/structural variation and gene fusions when compared to WGS and orthogonal technologies2.

Cutting edge technologies: Fusions and splice variants assessed via RNA analysis, which may detect more actionable fusions and splice variants, as compared to DNA tests only3-6.

References:

† Precise Tumor is powered by Intermountain Precision Genomics®, a service of Intermountain® Healthcare

  1. Conroy et al. A scalable high-throughput targeted next-generation sequencing assay for comprehensive genomic profiling of solid tumors. PLoS One. 2021 Dec 2;16(12):e0260089.
  2. Pestinger et al. Use of an Integrated Pan-Cancer Oncology Enrichment Next-Generation Sequencing Assay to Measure Tumour Mutational Burden and Detect Clinically Actionable Variants. Mol Diagn Ther. 2020 Jun;24(3):339-349.
  3. Benayed et al. High yield of RNA sequencing for targetable kinase fusions in lung adenocarcinomas with no mitogenic driver alteration as detected by DNA sequencing and low tumor mutation burden. Clin Cancer Res. 2019 August 01; 25(15):4712-4722.
  4. Wong et al. Methods for Identifying Patients with Tropomyosin Receptor Kinase (TRK) Fusions Cancer. Pathol Oncol Res. 2020 Jul; 26(3): 1385-1399.
  5. Yang et al. A Performance Comparison of Commonly Used Assays to Detect RET Fusions. Clin Cancer Res. 2020 Dec 3.
  6. Radonic et al. RET FISH Analysis is a sensitive by highly unspecific method for RET fusions in lung cancer. J Thora Oncol. 2021 Feb 12.

Assay Specifications

Sample Requirements* Cancer Type: Solid Tumor
Specimen Types: Cytology Cell Block
FFPE block requirement* Cross-sectional tumor area of 25mm2 containing at least 40 µm of tumor
Tumor Purity Minimum 20%
DNA input required 40 ng
RNA input required 40 ng
Limit of detection 5% VAF for SNV and INDELs
10 copies/ng for fusions
2.5-fold change for CNV
Panel size 523 genes assessed by DNA analysis
56 genes assessed by RNA analysis
Average total coverage/Depth of coverage Average 825x (validated average of >500x)
Since launch, average DNA reads (80M, or 825x) has remained above the stated validated average. Similarly, the average RNA reads (25M, or 1818x) is also high.
Analytical Sensitivity 99.25%
Analytical Specificity >99.9%

*See Precise Tumor Pathology Guide for additional details

Precise Tumor detects currently relevant DNA & RNA variants for multiple solid-tumor cancer types.

Some key cancer-specific biomarkers include:

Biomarkers included

Download full list of biomarkers

Download detailed aid

Download pathology guide

Download provider guide

Selecting optimal tissue specimen for a successful Precise Tumor test

Chemotherapy-naïve

Ideal specimen are chemotherapy-naïve tumors from primary debulking surgery or biopsy.

Chemotherapy-treated*

If patient has received neoadjuvant therapy, chemotherapy-treated tumors from primary debulking surgery may be submitted, but chemotherapy-naïve tumor from biopsy is preferred.

Biopsy

If debulking doesn’t provide sufficient tumor, pre-treatment biopsy samples should be considered.

Cytology

Cytology cell blocks (e.g., ascites fluid) are acceptable but tumor content must exceed 30%. Unfixed cytology samples are not appropriate for genomic testing.

* Pre-treatment biopsy samples should be considered in patients with complete or near-complete treatment response.

Additional considerations

  • Specimens should contain an area of tumor with at least 30% tumor cells in tissue or fluid samples by pathologic review.
  • Slides should be numbered in the order of cutting and match the pathology report. Clearly mark all slides with a minimum of 2 unique identifies (e.g., a full name and a block/pathology number).
  • Do not bake slides or use adhesives
  • If there is poor DNA quality or tumor heterogeneity, a higher tumor percentage may be required
  • If there is more than one block to choose from, the tissue from the block with the highest tumor percentage possible should be sent for testing
  • For small biopsies or tissue where area of tumor with high tumor content is very small, more than one block may be submitted simultaneously to increase the chances of extracting sufficient DNA

Tissue remaining in the block

Labs need to strike the appropriate balance between cutting enough tissue for diagnosis and preserving enough tissue for ancillary testing. Myriad will send back any remaining tissue block as soon as the test result is reported. Pre-cut unstained slides will not be returned.

Provider resources

Precise Tumor detailed aid

Complete pathology guide for Precise Tumor testing

Precise Oncology Solutions provider guide

Precise Oncology Solutions TRF

Precise Oncology Solutions TRF (fillable)

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