AuraSeq-Comprehensive

The AuraSeq-Comprehensive Panel is a highly multiplexed assay based on a next-generation sequencing platform. AuraSeq-Comprehensive identifies clinically relevant alterations in 500 cancer-related genes, including base pair substitutions, small insertions and deletions in thousands of mutational hotspots, as well as copy number variations, intergenic and intragenic fusions, and genomic signatures, allowing physicians to expand treatment options to include most FDA-approved targeted therapies.

TEST DESCRIPTION

The AuraSeq-Comprehensive Panel utilizes next-generation sequencing (NGS) technology to detect cancer-related genomic alterations such as single nucleotide variants (SNVs), small insertions and deletions (Indels), copy number variations (CNVs), and gene fusions; as well as genomic signatures such as tumor mutational burden (TMB), microsatellite instability (MSI), and homologous recombination (HR) repair gene alterations and genomic instability due to HR deficiency (HRD).

This test is intended to detect genomic alterations in several metastatic or advanced cancers, including:

•  Non-small cell lung cancer (NSCLC) (e.g.: EGFR, BRAF, ERBB2, KRAS, MET (METex14 and METamp), ALK-fusions, ROS1-fusions, RET-fusions). These genomic biomarkers are recommended by national guidelines.

• Colorectal cancer (CRC) (e.g.: MSI, KRAS, NRAS, BRAF, ROS1-fusions, NTRK1-fusions, NTRK3-fusions). Most of these biomarkers are recommended by national guidelines.

• Spitzoid melanoma (e.g.: TMB, NTRK1-fusions)

• Gliomas (e.g.: IDH1, IDH2, EGFRamp, EGFRvIII isoform, 1p/19q co-deletion, NTRK1-fusions, FGFR1-fusions, FGFR3-fusions)

• Bladder cancer (FGFR3-fusions)

• Breast cancer (e.g.: BRCA1, BRCA2, HR genes, NTRK3-fusions, FGFR1-fusions, FGFR2-fusions, FGFR3-fusions)

• Ovarian cancer (e.g.: HRD status, BRCA1, BRCA2, HR genes, NTRK3-fusions, FGFR1-fusions, FGFR2-fusions, and FGFR3-fusions)

• Prostate cancer (e.g.: HRD status, ERG-fusions, ETV1-fusions, ETV4-fusions, FGFR1-fusions)

• Pancreatic cancer (e.g.: HRD status, KRAS, SMAD4, NTRK1/2/3-fusions, ROS1-fusions)

• Soft tissue sarcomas (e.g.: NTRK1-fusions, NTRK3 -fusions)

• Any other advanced carcinoma which has failed to respond to conventional chemotherapy or is about to start tyrosine kinase inhibitors (TKIs), an immune checkpoint inhibitor (ICI) or a poly (ADP ribose) polymerase (PARP) inhibitor regime.

TEST ORDERING

The intended use of the AuraSeq-Comprehensive test is to detect somatic variants in multiple cancer driver genes and genomic signatures using NGS technology in advanced carcinoma samples to help guide therapeutic decisions, especially in those patients who have failed to respond to conventional chemotherapy or are about to start a TKI regime, Immune Checkpoint Inhibition (ICI), or PARP inhibitors (PARPi) therapies.

Physicians (or other individuals authorized by law to order tests) should only order tests that are medically necessary for the diagnosis or treatment of the patient.

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Request shipping kits or requisitions:

AuraSeq@sonichealthcareusa.com

or 904.296.2333 

References:

¹ Data on ~2300 samples submitted for AuraSeq testing.

² Nature. 2018;553(7689):446-454.

³ JAMA. 2021;325(7):669-685.

⁴ Cancer Cytopathol. 2019;127(5):285-296.

⁵ J Clin Pathol. 2021;207825.

⁶ Data on ~2300 samples submitted for AuraSeq testing.

⁷ J Oncol Pract. 2016;12(4):e396-404.

This test was developed and its performance characteristics determined by Sonic Healthcare USA, Anatomic Pathology and Bernhardt Laboratories. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes and should not be regarded as investigational or for research. Bernhardt Laboratories is qualified to perform high complexity testing under the Clinical Laboratory Improvement Amendments (CLIA). This test is considered an LDT- Laboratory Developed Test.

Copyright © 2022 Sonic Healthcare USA, Inc. All rights reserved. All of the information in this document is the property of Sonic Healthcare USA. It may not be distributed, transmitted, reproduced, copied or displayed without the written permission of Sonic Healthcare USA. Sonic Healthcare USA, including its affiliates, does not dispense medical advice. The content in this marketing collateral is intended for informational purposes only and does not constitute legal, medical or any professional advice.

Auraseq Comprehensive samples can not be recieved by the states of New York or California.