Skip to content

Bracanalysis Cdx

by Myriad Genetic Laboratories

PMA P140020

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P140020↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP140020 Date19 Dec 2014ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Generic Name
Cancer-related germline gene mutation detection system
PMA Number
FDA Product Code
PJG
Device Class
Class III
Advisory Committee
Pathology
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

BRACANALYSIS CDX is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes. It identifies single nucleotide variants, small insertions and deletions via PCR and Sanger sequencing, and large deletions and duplications using multiplex PCR, using genomic DNA from whole blood specimens collected in EDTA.

The test is for professional use only and must be performed exclusively at Myriad Genetic Laboratories' single site in Salt Lake City, UT. Results aid in identifying ovarian cancer patients with deleterious or suspected deleterious germline BRCA variants eligible for treatment with LYNPARZA (olaparib). The device has received FDA PMA authorization (P140020) and is classified as a Cancer-Related Germline Gene Mutation Detection System.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What type of specimen is required for the BRACANALYSIS CDX test?

    The BRACANALYSIS CDX test requires genomic DNA obtained from whole blood specimens collected in EDTA, as specified in the device's indications for use.

  • Where must the BRACANALYSIS CDX test be performed?

    The test is for professional use only and must be performed exclusively at Myriad Genetic Laboratories' single laboratory site located at 320 Wakara Way, Salt Lake City, UT 84108.

  • How does the BRACANALYSIS CDX detect large deletions and duplications in BRCA1 and BRCA2 genes?

    Large deletions and duplications in BRCA1 and BRCA2 are detected using multiplex PCR, as stated in the device's specifications.