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FDA-approved companion diagnostic

therascreen PIK3CA RGQ PCR Kit

Real-time PCR assay on the Rotor-Gene Q that qualitatively detects selected PIK3CA exon 7, 9, and 20 mutations in FFPE tumor tissue to support targeted treatment decisions.

IVD-developed CDxMethod: PCRSpecimen: Tissue (FFPE), PlasmaBiomarker: PIK3CA mutation status
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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
P190001
Supplements
Manufacturer
QIAGEN GmbH (Qiagen)
Approval date
May 24, 2019
Test specifications
Methodology
PCR
Specimen
Tissue (FFPE), Plasma
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
PIK3CA mutation status
What this test is

The therascreen PIK3CA RGQ PCR Kit is an in vitro diagnostic, allele-specific real-time PCR assay that qualitatively detects selected PIK3CA mutations in exons 7, 9, and 20 in DNA from formalin-fixed, paraffin-embedded tumor tissue. Used on the Rotor-Gene Q instrument, it reports mutation detected or not detected to establish PIK3CA mutation status and support PIK3CA-targeted treatment planning.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Breast CancerPIK3CAC420R, E542K, E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R, H1047L, H1047R, and H1047YPIQRAY

IVD Manufacturer

QIAGEN GmbH (Qiagen)

QIAGEN N.V., a Netherlands-based holding company, is a global leader in Sample to Insight solutions that enable customers to extract and analyze molecular information from biological samples containing the building blocks of life. Our Sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies prepare these biomolecules for analysis, while bioinformatics support the interpretation of complex data to deliver actionable insights. Automation solutions integrate these steps into streamlined, cost-effective workflows. QIAGEN serves more than 500,000 customers worldwide in the Life Sciences (academia, pharmaceutical R&D and industrial applications such as forensics) and Molecular Diagnostics (clinical healthcare). As of September 30, 2025, QIAGEN employed approximately 5,700 people across more than 35 locations. For more information, visit www.qiagen.com.

Order this test

If your organization is connected to Casandra, you can place an electronic order fortherascreen PIK3CA RGQ PCR Kit 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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