oncoReveal^® CDx
Pan-Cancer Solid Tumor IVD

FDA Approved

oncoReveal^™ CDx is an FDA PMA-approved, NGS-based companion diagnostic (CDx) kit providing comprehensive genomic results, covering 22 clinically relevant genes. oncoReveal CDx has a single-tube workflow that can be performed by any clinical laboratory, providing sample-to-clinical report in less than 48 hours.

oncoReveal CDx has been clinically and analytically validated across all major solid tumors. The assay kit is designed to provide clinically actionable information — both to consider appropriate CDx therapies in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC), and to aid in the identification of other clinically significant genomic alterations for patients with solid tumors.

Table 1: Approved Companion Diagnostic and Tumor-Profiling Indications

ABL1	BRAF	CEBPA	ETV6	HRAS	KDM6A	NPM1	PTEN	SMC1A	TP53
ANKRD26	CALR	CSF3R	EZH2	IDH1	KIT	NRAS	PTPN11	SMC3	U2AF1
ASXL1	CBL	CUX1	FLT3	IDH2	KMT2A	PDGFRA	RAD21	SRSF2	WT1
ATRX	CBLB	DDX41	GATA1	IKZF1	KRAS	PHF6	RUNX1	STAG1	ZRSR2
BCOR	CBLC	DNMT3A	GATA2	JAK2	MPL	PIGA	SETBP1	STAG2
BCORL1	CDKN2A	ETNK1	GNAS	JAK3	NF1	PPM1D	SF3B1	TET2

ABL1	DDX41	KDM6A	RUNX1
ANKRD26	DNMT3A	KIT	SETBP1
ASXL1	ETNK1	KMT2A	SF3B1
ATRX	ETV6	KRAS	SMC1A
BCOR	EZH2	MPL	SMC3
BCORL1	FLT3	NF1	SRSF2
BRAF	GATA1	NPM1	STAG1
CALR	GATA2	NRAS	STAG2
CBL	GNAS	PDGFRA	TET2
CBLB	HRAS	PHF6	TP53
CBLC	IDH1	PIGA	U2AF1
CDKN2A	IDH2	PPM1D	WT1
CEBPA	IKZF1	PTEN	ZRSR2
CSF3R	JAK2	PTPN11
CUX1	JAK3	RAD21

Genes marked in green indicate full CDS coverage

Simple NGS Library Prep Workflow

Maintain control of samples and results with single-tube, tiled amplification that can be performed in-house by any NGS lab

Sensitive and Robust Chemistry

Achieve variant detection as low as 1% VAF* even with limited DNA input or poor sample quality

Reduced Fully-Loaded Lab Costs

Improve lab efficiency and reduce “no calls”, repeat testing, and difficult interpretation decisions

*VAF, variant allele frequency
For Research Use Only. Not for use in diagnostic procedures..

Panel Specifications*

Enrichment chemistry	Multiplex PCR using tiled amplicons
Number of pools	1 pool
Number of genes/amplicons	58/766
Number of targets	Full CDS coverage of 18 genes, hotspots in 40 additional genes, FLT3 ITDs; 107.9kb total size
Variant types	SNVs, indels, ITD (internal tandem duplicates)
Average amplicon size	217bp
Recommended DNA input range	20ng to 60ng (20ng recommended)
Sample types	DNA from whole blood, PBMCs
Mapping rate	99.6% ± 0.2%
% on-target aligned reads	92.0% ± 5.3%
Coverage uniformity (% targets with >0.2X mean coverage)	96.8% ± 1.0%
Recommended Reads Per Sample	~4 million paired-end reads
Total assay time (from DNA to sequencer)	<8 hours

*Mapping rate, percentage of on-target aligned reads, and coverage uniformity metrics are based on internal testing performed using reference standard materials

Ordering Information

Select the panel and one of the index kit options listed below.

Panel	Part Number
oncoReveal® Myeloid Panel (24 reactions)	HDA-MY-1001-24

Pillar Index Kit Options	Reactions	Part Number
Pillar Custom Index Primers Kit A	32 Combinations, 96 Reactions	IDX-PI-1001-96
Pillar Custom Index Primers Kit D	96 Combinations, 192 Reactions	IDX-PI-1004-192

User Guide

Myeloid Panel

Product Sheet