The NeXT Dx Test is a laboratory developed test performed at Personalis’ CAP-accredited and CLIA’88- certified laboratory. It is intended for profiling a solid tumor’s genomic and molecular characteristics using clinical-grade, next-generation sequencing (NGS) technology to report small nucleotide variants (SNVs), small insertions and deletions (indels), copy number alterations (CNAs), and fusions in up to 247 cancer related genes. Additionally, MSI and exome-wide “true” TMB is reported by leveraging the exome-wide analysis of non-synonymous small variants (SNVs and indels both).
The NeXT Dx Test is validated for solid tumor FFPE samples. Unacceptable specimens include hematolymphoid malignancies or decalcified bone. Additionally, samples from patients living in New York State are not acceptable at this time.
The NeXT Dx Test utilizes DNA and RNA isolated from patient’s tumor tissue to perform whole exome and transcriptome analysis respectively. The clinical report includes SNVs, indels, CNAs, MSI and TMB results derived from DNA analysis and fusion results derived from RNA analysis.