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FDA-approved companion diagnostic
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FoundationFocus CDxBRCA Assay

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

Lab-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
P160018
Supplements
Manufacturer
Foundation Medicine, Inc.
Approval date
December 19, 2016
Test specifications
Methodology
NGS (hybrid capture)
Turnaround (typical)
Not specified
Report format
Comprehensive report PDF
What this test is

FoundationFocus CDxBRCA Assay 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)
Ovarian CancerBRCA1 and BRCA2alterations (including mutations)RUBRACA

Performing lab

Foundation Medicine, Inc.

Boston Lab (22D2027531)

At Foundation Medicine, our mission is to transform lives in cancer and beyond. We strive to provide multi-modal precision diagnostic solutions to transform cancer care throughout a patient’s experience, from pre-diagnosis to ongoing management and monitoring. Leveraging our vast knowledge of precision medicine, we partner with biopharmaceutical companies to accelerate the development of new personalized therapies in cancer and in a range of other diseases. For more information, visit us at www.FoundationMedicine.com and follow us on LinkedInXYouTubeFacebook and Instagram.

Order this test

If your organization is connected to Casandra, you can place an electronic order for FoundationFocus CDxBRCA Assay 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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