Home·Know Your Companions™·Tests·ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)
FDA-approved companion diagnostic

ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)

NGS-based tissue assay that detects EGFR and KRAS variants in FFPE NSCLC and colorectal tumors to help guide targeted treatment decisions.

IVD-developed CDxMethod: NGSSpecimen: Tissue (FFPE)Biomarker: EGFR exon 19 deletion and L858R variants, KRAS exon 2 codon 12/13 variants
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Casandra.ai provides a unified ordering experience so you can request this test directly from the performing lab, without changing your workflow.

Ordering is available where Casandra has an active integration with the performing lab. Labs that offer this test can connect with us to enable digital ordering.

About this test

FDA approval details
PMA number
P200011
Supplements
Manufacturer
Pillar Biosciences, Inc.
Approval date
July 30, 2021
Test specifications
Methodology
NGS
Specimen
Tissue (FFPE)
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
EGFR exon 19 deletion and L858R variants, KRAS exon 2 codon 12/13 variants
What this test is

ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA) is an FDA-approved, qualitative, amplicon-based NGS test that detects specified EGFR and KRAS single nucleotide variants and deletions in DNA from FFPE NSCLC and colorectal tumor tissue. Run on the Illumina MiSeqDx platform, it determines EGFR and KRAS mutation status to support selection of appropriate targeted therapies.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Colorectal Cancer (CRC)KRASKRAS wild-type (absence of mutations in codons 12 and 13)ERBITUX, VECTIBIX
Non-Small Cell Lung Cancer (NSCLC)EGFR (HER1)Exon 19 deletion or exon 21 L858R substitution mutationGILOTRIF, IRESSA, LAZCLUZE + RYBREVANT, TAGRISSO, TARCEVA, VIZIMPRO

IVD Manufacturer

Pillar Biosciences, Inc.

Pillar Biosciences is a leader in Decision Medicine™—leveraging highly accurate and sensitive next-generation sequencing (NGS) technologies to optimize precision therapy selection for cancer patients, from tumor profiling to treatment selection and recurrence monitoring. Powered by its proprietary SLIMamp® and PiVAT® technologies, Pillar’s localized testing approach helps reduce diagnostic costs, improve turnaround times, and expand access to high-quality NGS testing globally.

The company offers more than 20 NGS testing kits in IVD or RUO formats, with multiple panels in various stages of development. Pillar Biosciences is headquartered in Natick, Massachusetts.

For more information, visit pillarbiosci.com and connect with us on LinkedIn.

Order this test

If your organization is connected to Casandra, you can place an electronic order forONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA) directly from your existing workflow.

Casandra connects providers, labs, and sponsored programs so that companion diagnostics can be ordered consistently and documented cleanly, regardless of which system you start from.

CDxTests.com is an informational resource for providers. Always refer to the official FDA labeling and laboratory documentation when making treatment decisions.

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