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FDA-approved companion diagnostic

InSite Her-2/neu (CB11) Monoclonal Antibody

A comprehensive genomic profiling assay used as a companion diagnostic to select patients for targeted therapies across multiple solid tumors.

IVD-developed CDxMethod: NGS (Hybrid Capture)Biomarker: Multiple genomic alterations
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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
P040030
Supplements
Manufacturer
Biogenex Laboratories, Inc.
Approval date
December 22, 2004
Test specifications
Methodology
NGS (hybrid capture)
Turnaround (typical)
Not specified
Report format
Comprehensive report PDF
What this test is

InSite Her-2/neu (CB11) Monoclonal Antibody is an in vitro diagnostic test that uses next-generation sequencing to identify genomic alterations in solid tumors. It is approved by the FDA as a companion diagnostic for multiple targeted therapies across tumor types.

Results from this assay help determine whether a patient is eligible for specific therapies based on the genomic profile of their tumor.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Breast CancerERBB2 (HER2)HER-2 protein overexpressionHERCEPTIN

IVD Manufacturer

Biogenex Laboratories, Inc.

BioGenex designs, develops and commercializes molecular pathology systems for Tumor diagnosis, prognosis, precision medicine and life science research. BioGenex’s industry-leading next-generation cytogenetic FISH workflow solution and miRNA system for characterization of Cancer of Unknown Primary (CUP) and undifferentiated tumors are revolutionizing pathology. Proprietary fully-automated molecular pathology workstations from BioGenex are the most advanced systems available globally. BioGenex prides itself on delivering cutting edge technology, years ahead of the competition, providing the finest systems for immunohistochemistry (IHC), in situ hybridization (ISH), Fluorescence ISH (FISH) and in situ PCR. BioGenex systems and product performance are guaranteed: antibodies, probes, antigen retrieval, detection systems, and histology stains. We provide quality systems and are committed to best in class customer care.

Order this test

If your organization is connected to Casandra, you can place an electronic order forInSite Her-2/neu (CB11) Monoclonal Antibody 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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