Vietnam MOH registration 2400283ĐKLH/BYT-HTTB

The PIK3CA gene mutation detection kit 11

VN: Bộ xét nghiệm phát hiện 11 đột biến trên gen PIK3CA

Vietnam·Risk Class TTBYT Loại C·Therascreen PIK3CA RGQ PCR Kit·QIAGEN GmbH·Registered Feb 23, 2024

Registration details

Analysis ID: 2400283ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-211103-0012
Product Type: Therascreen PIK3CA RGQ PCR Kit
Product Code: 873111

Company information

Manufacturer: QIAGEN GmbH
Manufacturer Country: GERMANY
Authorized Representative: CÔNG TY TNHH THIẾT BỊ Y TẾ PHƯƠNG ĐÔNG

Technical details

Intended Use: The therascreen PIK3CA RGQ PCR kit is a real-time quantitative PCR test to detect 11 mutations in the gene phosphatidylinositol 3-kinase catalytic subunit alpha (PIK3CA) (Exon 7: C420R; Exon 9: E542K, E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R; and Exon 20: H1047L, H1047R, H1047Y) using DNA genome (gDNA) extracted from the formalin-fixed, paraffin-embedded (FFPE) tumor tissue biopsy obtained from breast cancer patients. The therascreen PIK3CA RGQ PCR kit is designed to be used as a companion diagnostic test, to assist clinical oncologists in determining which breast cancer patients are eligible for treatment with PIQRAY® (alpelisib) based on the PIK3CA mutation results. Patients with FFPE tumor tissue samples that have a positive result for the PIK3CA RGQ PCR Kit are considered to have the presence of one or more PIK3CA mutations that are eligible for treatment with PIQRAY (alpelisib). The FFPE tumor tissue biopsy samples are processed using the QIAamp DSP DNA FFPE Kit to prepare the manual samples. The HRM Rotor-Gene Q (RGQ) MDx 5plex device is used to amplify and automatically detect the mutations. The therascreen PIK3CA RGQ PCR kit is an in vitro diagnostic medical device. The therascreen PIK3CA RGQ PCR kit is used by trained laboratory personnel

Dates and status

Registration Date: Feb 23, 2024

About this record

Access comprehensive regulatory information for The PIK3CA gene mutation detection kit 11 in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2400283ĐKLH/BYT-HTTB and manufactured by QIAGEN GmbH. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ Y TẾ PHƯƠNG ĐÔNG.

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