Find the Right Companion Diagnostic

Search by indication, biomarker, therapy, or test. Confirm which assay meets FDA requirements and see where it can be ordered, all in one place.

Featured Companion Diagnostics

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Companion Diagnostic
Ventana HER2 Dual ISH DNA Probe Cocktail
Ventana Medical Systems, Inc. (Roche Diagnostics)

VENTANA HER2 Dual ISH DNA Probe Cocktail is an FDA-approved, dual-color chromogenic in situ hybridization assay that uses HER2 and chromosome 17 DNA probes to assess HER2 gene amplification in FFPE breast and gastric or gastroesophageal junction cancer tissue. Performed on VENTANA BenchMark instruments, it reports HER2/Chr17 ratios to classify tumors as HER2-negative or HER2-amplified for treatment planning.

Breast Cancer
Companion Diagnostic
PATHWAY anti-Her2/neu (4B5) Rabbit Monoclonal Primary Antibody
Ventana Medical Systems, Inc. (Roche Diagnostics)

PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody is an FDA-approved, semi-quantitative immunohistochemistry reagent for detecting HER2 antigen in formalin-fixed, paraffin-embedded breast and gastric tissue on VENTANA BenchMark IHC/ISH instruments. Using standardized 0–3+ membrane staining criteria, it classifies tumors by HER2 protein expression to support HER2-directed treatment decisions.

Breast Cancer
Companion Diagnostic
Oncomine Dx Target Test
Life Technologies Corporation (ThermoFisher Scientific)

Oncomine Dx Target Test is an FDA-approved, qualitative targeted NGS assay performed on the Ion PGM Dx System. Using DNA and RNA from FFPE tumor tissue, it detects single-nucleotide variants, insertions, deletions, and fusions in a defined panel of cancer driver genes. It is approved for use in NSCLC and several other solid tumors to characterize oncogenic alterations and support selection of targeted treatment strategies.

Non-Small Cell Lung Cancer (NSCLC)

Know Your Companions™

An intuitive report that maps indications, biomarkers, biomarker details, therapies, and eligible tests. Built from FDA approvals and CDx labeling.

IndicationBiomarkerBiomarker detailsDrug / therapy
Breast CancerERBB2 (HER2)Gene amplification (ISH amplified)ENHERTU + PERJETA
Non-Small Cell Lung Cancer (NSCLC)ERBB2 (HER2)Activating mutations in the tyrosine kinase domain (SNVs in exons 18-21 and exon 20 insertions)HYRNUO
Endometrial Carcinoma (EC)Microsatellite stable/MSS (Not MSI-High)MSS (Not Microsatellite instability high/not MSI-H)KEYTRUDA + LENVIMA

View all 221 approvals and eligible tests.

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For pharma teams

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For laboratories

If your lab performs an FDA-approved CDx or a validated LDT alternative, you can appear in provider workflows and support digital ordering through Casandra.

  • • Be listed where providers search for companion diagnostics.
  • • Connect to Casandra for streamlined ordering.
  • • Align your offerings with Know Your Companions™ mapping.
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