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510(k) Data Aggregation
(240 days)
Omics Core
The Omics Core assay is a qualitative in vitro diagnostic test that uses targeted next generation sequencing of formalin-fixed paraffinembedded tumor tissue matched with normal specimens with solid malignant neoplasms to detect tumor gene alterations in a broad multi gene panel. The test is intended to provide informations (point mutations (point mutations and deletions) and tumor mutational burden (TMB) for use by qualified health care professionals in accordance with professional guidelines, and is not conclusive or prescriptive for labeled use of any specific therapeutic product. Omics Core is a single-site assay performed at NantHealth, Inc.
The NantHealth Omics Core assay is a custom targeted whole exome sequencing platform, utilizing solution-phase exon capture and sequencing, to report somatic alterations (point mutations, small insertions and deletions) in 468 genes and sequencing of 19,396 protein-coding genes (whole exome) to determine overall tumor mutation burden in tumor specimens. Genomic DNA is extracted from both a tumor and a patient-matched normal control sample. Sequence libraries are prepared through a series of enzymatic steps including shearing of double-stranded DNA, end repair, A-base addition, ligation of barcoded sequence adaptors, and low cycle PCR amplification. Single barcoded sequence libraries are captured using the biotinylated probes. Captured DNA fragments are then pooled and sequenced on an Illumina NovaSeq 6000 as paired-end reads. Sequence reads are then aligned to the reference human genome. Somatic alterations are identified in the tumor DNA by direct comparison to the matched normal DNA.
The Omics Core assay, a targeted next-generation sequencing test, was evaluated to determine its performance specifications, including precision, analytical sensitivity (Limit of Detection), and accuracy.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" as a separate column with specific numerical thresholds for each performance metric. Instead, it presents "Performance Specifications" as the expected or demonstrated performance of the device based on the studies. The reported device performance is then detailed under each characteristic.
Table: Omics Core Performance Specifications and Reported Device Performance
| Characteristic | Performance Specifications (Implicit Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Precision – Panel-Wide Reproducibility | Demonstrated with a high overall positive call rate for all variants analyzed. | The overall positive call rate for all variants analyzed across the 12 FFPE clinical samples and one commercial cell line was 2607/2650, or 98.4% (97.8-98.8% CI). |
| Precision – Per Specimen | Demonstrated with consistent repeatability and reproducibility. | Per specimen variant analysis for 12 clinical specimens and a commercial cell line demonstrated 100% concordance for 511 out of 530 unique mutations, or 96.4% (94.5%-97.8% CI). |
| Precision - Well Characterized Reference Material | Demonstrated consistent repeatability and reproducibility. | Analysis of the well-characterized sample demonstrated an overall positive call rate of 99.86% (99.75%-99.93% CI). |
| Precision - TMB | Demonstrated repeatable and reproducible TMB rates. | TMB precision analysis based on 12 clinical samples and 1 commercial cell line showed repeatable and reproducible TMB rates with a **%CV |
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