Pillar® ONCO/Reveal™ Dx Lung and Colon Cancer Assay

One assay for six lung and colon cancer therapies

The ONCO/Reveal Dx Lung and Colon Cancer Assay is the first next-generation sequencing (NGS)-based companion diagnostic (CDx) kit that detects somatic mutations in DNA derived from formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) tumor tissue. This robust NGS assay is intended to be used to select patients with NSCLC or CRC that may benefit from treatment with targeted therapies.
CE IVD mark
For In Vitro Diagnostic Use in Europe. Not yet available in the US.

Intended use

Indication Gene Variant Targeted Therapy
Colorectal Cancer (CRC) KRAS KRAS wild-type (absence of mutations in codons 12 and 13) Erbitux (cetuximab), or Vectibix (panitumumab)
Non-Small Cell Lung Cancer (NSCLC) EGFR Exon 19 Deletions Exon 21 L858R Tarceva (erlotinib), Gilotrif (afatinib), Iressa (gefitinib), or Vizimpro (dacomitinib)

Make treatment decisions faster with multiplex testing

Sensitive and robust variant detection

SLIMamp workflow removes unwanted overlapping amplicons for greater NGS sensitivity

Single-day library preparation

The ONCO/Reveal Dx Lung and Colon Cancer Assay uses Pillar Bioscience’s proprietary SLIMamp® chemistry to enable amplification of overlapping amplicons in a single tube. This approach decreases contamination risks and minimizes the amount of required input DNA to just 10ng (see Figure 1). The resulting simplified workflow consists of just two PCR steps and two cleanup steps, so you can go from sample to sequencer in under 8 hours (see Figure 2).

Single day data analysis

The Pillar PiVAT® bioinformatics platform that accompanies the ONCO/Reveal Dx Lung and Colon Cancer Assay is maximized for efficiency and sensitivity, delivering answers in less than 8 hours for variant allele frequencies down to 1.6% with minimal computing resources. The test is accompanied by a workstation (additional purchase required) for
intuitive, cyber-secure reporting. The platform’s built-in sample sheet tool also makes batching easy.

Pillar's SLIMamp workflow includes just four steps: amplification, cleanup, index, and one more cleanup step.

Reproducible and concordant with previously approved assays

Concordance with relevant IVD-cleared assays

Gene PPAa NPAb
EGFR (91/91) 100% (163/166) 98.2%
KRAS (79/81) 97.5% (103/104) 99.0%
aNumber of samples with mutation according to Pillar ONCO/Reveal Dx Lung and Colon Cancer Assay divided by the number of samples with mutation according to comparator bNumber of samples identified as wild-type by Pillar ONCO/Reveal Dx Lung and Colon Cancer Assay divided by the number of samples identified as wild-type by comparator

Reproducibility* data

Gene True Positives
KRAS variant (360/360) 100%
EGFR variant (360/360) 100%

*Evaluated at 3 sites with 2 operators at each site performing 3 runs on
non-consecutive days using 2 reagent lots at each site. Each panel member
was tested in 4 replicates in each run for total of 360 possible results.

Variants with established analytical performance

Gene Variant ID Cancer Nucleotide Change
EGFR T790M NSCLC c.2369C>T
EGFR G719A NSCLC c.2156G>C
EGFR G719C NSCLC c.2154_2155delinsTT; c.2155G>T
EGFR G719D NSCLC c.2156G>A
EGFR G719S NSCLC c.2155G>A
EGFR Exon 20 In-frame Insertions NSCLC Multiple
BRAF V600E NSCLC c.1799T>A; c.1799_1800delinsAA
KRAS Exon 2 Mutation NSCLC Multiple
KRAS A59E CRC c.176C>A
KRAS A59G CRC c.176C>G
KRAS A59T CRC c.175G>A
KRAS A59S CRC c.175G>T
KRAS Q61E CRC c.181C>G
KRAS Q61H CRC c.183A>C ; c.183A>T
KRAS Q61K CRC c.180_181delinsAA ; c.180_181inv ; c.181C>A
KRAS Q61L CRC c.182A>T ; c.182_183delinsTC ; c.182_183delinsTG ; c.182_183inv
KRAS Q61R CRC c.182A>G ; c.182_183delinsGC ; c.182_183delinsGT
KRAS K117N CRC c.351A>C ; c.351A>T
KRAS A146T CRC c.436G>A
KRAS A146P CRC c.436G>C
KRAS A146V CRC c.437C>T
BRAF V600E CRC c.1799T>A ; c.1799_1800delinsAA

Ordering information

Product Part Number
ONCO/Reveal Dx Lung and Colon Cancer Assay, 48 reaction kit HDA-LC-2002-48
Cyber secure ONCO/Reveal Dx Lung and Colon Cancer Assay PiVAT Workstation SFW-2005
Pillar MiSeqDx LRM Module SW-0001

*MiSeqDx is a trademark of Illumina, Inc.

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