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Therascreen PIK3CA RGQ PCR Kit

FDA PMA

Class III (US FDA PMA)

PMA P190001

by QIAGEN GmbH

Identity

Trade Name
therascreen PIK3CA RGQ PCR Kit FDA PMA
Generic Name
Somatic gene mutation detection system FDA PMA

Identifiers

PMA Number
P190001 FDA PMA
FDA Product Code
OWD FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Medical Genetics FDA PMA
FDA Decision
APPR Approved FDA PMA

The Therascreen PIK3CA RGQ PCR Kit is a real-time qualitative PCR test used for the detection of 11 specific mutations in the phosphatidylinositol 3-kinase catalytic subunit alpha (PIK3CA) gene. It utilizes genomic DNA extracted from formalin-fixed, paraffin-embedded breast tumor tissue or circulating tumor DNA from plasma to identify patients who may be eligible for treatment with PIQRAY (alpelisib).

This test is intended for use by trained personnel in a professional laboratory environment using the Rotor-Gene Q MDx instrument for automated amplification and detection. Specimens are processed using the QIAamp DSP DNA FFPE Tissue Kit or the QIAamp DSP Circulating Nucleic Acid Kit. The device has received FDA PMA approval for its intended use in identifying PIK3CA mutation status.

Frequently asked questions

What does the Therascreen PIK3CA RGQ PCR Kit detect?

The kit is a qualitative PCR test that detects 11 specific mutations in the PIK3CA gene, including variants in Exon 7, Exon 9, and Exon 20, which are associated with breast cancer.

What specimen types are required for this test?

The test uses either genomic DNA extracted from formalin-fixed, paraffin-embedded (FFPE) breast tumor tissue or circulating tumor DNA (ctDNA) from plasma derived from K2EDTA anticoagulated peripheral whole blood.

What happens if a plasma specimen produces a negative result?

If a patient's plasma specimen produces a negative result for PIK3CA mutations, the protocol requires that the patient be reflexed to testing with FFPE tumor tissue to confirm the mutation status.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
QIAGEN GmbH

Sources (1)

  • FDA PMA P190001 24 fields · synced Sep 18, 2026