NeXT Dx™ Test

The Personalis NeXT Dx™ Test* is a comprehensive genomic testing solution that enables oncologists to identify potential therapies and clinical trial options for cancer patients. The NeXT Dx Test is one of the first cancer diagnostic test to profile ~20,000 cancer related genes in both tumor exome and transcriptome. The clinical report documents the genetic alterations found in 248 clinically-relevant, cancer genes, as well as research data that can provide insights into emerging immunotherapy composite biomarkers of medical importance. Single nucleotide variants (SNVs), insertions/deletions (indels), copy number alterations (CNAs), and gene fusions for targeted therapy selection, as well as tumor mutational burden (TMB) and microsatellite instability (MSI) status, are reported for immunotherapy selection.

248

Clinically Relevant
Cancer Genes Evaluated
for Solid Tumor

Enhanced
Fusion
Detection

With RNA
Analysis

133

Clinically Relevant
Genes Evaluated
for Copy Number Alterations

Expanded
Biomarker
Testing

MSI and Exome-wide
TMB Measurement

For ordering inquiry please contact Personalis at clinical@personalis.com.

Who can use the test?

Next Generation Cancer Care: Results Unique to Your Patient

Personalis provides clinicians with clinically-focused cancer test results that maximize the chance of identifying an approved therapy or trial for each patient as well as information that can support identification of new, advanced biomarkers. These results are unique to the patient’s tumor, cover cancer genes known to be relevant in solid tumors, and provide more potential treatment options than other limited tests.

Unique to NeXT Dx

Improved detection of alterations in difficult-to-sequence regions of clinically important genes via proprietary methods.
Analysis of DNA and RNA from the same sample to enable robust identification of gene fusions.
Integration of immunotherapy-related biomarkers such as MSI and exome-wide TMB.
Determination of TMB by utilizing the gold-standard, exome-wide analysis of non-synonymous somatic mutations (SNVs and indels).

Enhanced
Coverage and
Uniformity

Personalis’ proprietary technology augments coverage of more complex and problematic regions not adequately addressed by standard panels.

Accurate
Identification
of SNVs,
Indels, CNAs
and Fusions

Personalis delivers variant calls through: advanced sequencing alignment tools, sophisticated algorithms, and knowledge of systematic biases inherent in sequencing technologies.

Comprehensive
Analysis including MSI and Exome-wide TMB

MSI status is derived using five canonical loci (BAT25, BAT26, NR-21, NR-24, and NR-27). Exome-wide TMB is reported as the number of non-synonymous mutations per megabase.

Clinically
Actionable
Report

Each variant is reviewed in detail by Personalis’ clinical team, and is assessed for clinical relevance in relation to the latest evidence-based therapy recommendations and available clinical trials.

Results are presented in a clear, intuitive report so healthcare providers can rapidly understand and assess the results.

Standard Clinical Reporting

The NeXT Dx Test report delivers clinically important genomic alterations based on a comprehensive and dynamic variant classification and curation process involving multiple genetic information sources. Our database of potentially relevant therapies and clinical trial matches is continually updated based on the latest scientific and medical evidence.

For ordering inquiry please contact Personalis at clinical@personalis.com.

*Currently only available in the United States (excluding NY state samples at this time).

Oncology Diagnostics