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Therascreen PIK3CA RGQ PCR Kit

FDA PMA

Class III (US FDA PMA)

PMA P190004

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
P190004 FDA PMA
FDA Product Code
OWD FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Medical Genetics FDA PMA
FDA Decision
APCB FDA PMA

The therascreen PIK3CA RGQ PCR Kit is a real-time qualitative PCR test classified as a somatic gene mutation detection system. It is designed to detect 11 specific mutations in the PIK3CA gene (Exon 7: C420R; Exon 9: E542K, E545A, E545D, E545G, E545K, Q546E, Q546R; Exon 20: H1047L, H1047R, H1047Y) using 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. This test aids in identifying breast cancer patients who may be eligible for targeted therapy based on PIK3CA mutation status.

The kit is intended for use in professional laboratory settings by trained personnel. FFPE tumor specimens require processing with the QIAamp DSP DNA FFPE Tissue Kit, while plasma specimens are processed using the QIAamp DSP Circulating Nucleic Acid Kit. The Rotor-Gene Q (RGQ) MDx instrument automates amplification and detection. The kit is supplied as a single-use reagent system and has received FDA Premarket Approval (PMA) under P190004. No additional regulatory markings or MRI safety considerations are specified.

Frequently asked questions

What specific mutations in the PIK3CA gene does the therascreen PIK3CA RGQ PCR Kit detect, and why is this relevant for breast cancer patients?

The therascreen PIK3CA RGQ PCR Kit detects 11 specific mutations in the PIK3CA gene: C420R (Exon 7), E542K, E545A, E545D (1635G>T only), E545G, E545K, Q546E, Q546R (Exon 9), and H1047L, H1047R, H1047Y (Exon 20). These mutations are clinically relevant because they can help identify breast cancer patients who may benefit from targeted therapy with PIQRAY® (alpelisib), a treatment approved for patients with PIK3CA mutations.

What types of samples can be tested using this kit, and how are they prepared before analysis?

The kit is designed to analyze two types of samples: formalin-fixed, paraffin-embedded (FFPE) breast tumor tissue and circulating tumor DNA (ctDNA) from plasma derived from K2EDTA anticoagulated peripheral whole blood. FFPE samples require processing with the QIAamp DSP DNA FFPE Tissue Kit, while plasma samples are processed using the QIAamp DSP Circulating Nucleic Acid Kit. Both specimen types must be prepared manually before automated amplification and detection on the Rotor-Gene Q (RGQ) MDx instrument.

Is the therascreen PIK3CA RGQ PCR Kit intended for single-use or reusable applications, and how does this affect workflow?

The kit is supplied as a single-use reagent system, meaning each kit is designed for one test run. This ensures consistency and reliability in results, as reuse could introduce contamination or variability. Laboratories must order multiple kits for repeated testing, which helps maintain workflow efficiency while adhering to best practices for molecular diagnostics.

What instrument is required to perform the amplification and detection steps of this test, and is it compatible with both sample types?

The Rotor-Gene Q (RGQ) MDx (US) instrument is required for automated amplification and detection of the PIK3CA mutations in both FFPE tumor tissue and plasma-derived ctDNA samples. The kit is specifically validated for use with this instrument, ensuring accurate and reproducible results for both specimen types.

What should clinicians do if a plasma sample tests negative for PIK3CA mutations but the patient’s breast cancer may still be eligible for targeted therapy?

If a plasma sample yields a negative result, the AO statement specifies that the patient’s FFPE tumor tissue should be reflexed to testing with the same kit. This ensures comprehensive mutation detection, as mutations may be present in the tumor tissue but not detectable in circulating tumor DNA, allowing clinicians to determine full eligibility for PIQRAY® treatment.

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. Sources consulted: therascreen PIK3CA RGQ PCR Kit - QIAGEN, PDF May 2019 therascreen PIK3CA RGQ PCR Kit Instructions for Use (Handbook), therascreen PIK3CA RGQ PCR Kit (P190001) — FDA 510 (k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
QIAGEN GmbH

Sources (1)

  • FDA PMA P190004 24 fields · synced Sep 20, 2026