Skip to content

Idylla CDx MSI Test

by Biocartis Us, Inc.

PMA P250005

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 P250005↗

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 NumberP250005 Date15 Aug 2025ApprovedStatusActive

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  • Withdrawn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
Nucleic Acid Based Assay, Microsatellite Instability
PMA Number
FDA Product Code
SFL
Device Class
Class III
Advisory Committee
Medical Genetics
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.

The Idylla CDx MSI Test is an in vitro diagnostic test for the qualitative detection of seven monomorphic biomarkers (ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A and SULF2) to identify microsatellite instability (MSI) in colorectal cancer (CRC) tissue. It uses formalin-fixed, paraffin embedded (FFPE) tissue sections from CRC patients, extracting nucleic acids and analyzing them through PCR amplification and melt-curve analysis to report MSI status as Microsatellite Stable (MSS), Microsatellite Instability-High (MSI-H), or invalid.

The test is intended as a companion diagnostic to identify CRC patients with MSI-H status who may benefit from treatment with OPDIVO (nivolumab) as monotherapy and/or in combination with YERVOY (ipilimumab). It is for in vitro diagnostic use only, requires prescription, and is designed for use exclusively on the Biocartis Idylla System. The device is classified as a Class III nucleic acid-based assay for microsatellite instability.

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 is the purpose of the Idylla CDx MSI Test?

    The test is designed to detect microsatellite instability (MSI) in colorectal cancer tissue by identifying seven specific biomarkers. It helps identify patients with MSI-H status who may benefit from treatment with OPDIVO (nivolumab) alone or in combination with YERVOY (ipilimumab).

  • What type of tissue sample is required for the Idylla CDx MSI Test?

    The test requires formalin-fixed, paraffin embedded (FFPE) tissue sections from patients with colorectal cancer. These samples are used to extract nucleic acids for analysis through PCR amplification and melt-curve analysis.

  • How is the Idylla CDx MSI Test supplied and stored?

    The test is supplied as an in vitro diagnostic device that must be used exclusively on the Biocartis Idylla System. It requires prescription and is for in vitro diagnostic use only. Specific storage conditions are not detailed in the provided information.

  • What are the possible results from the Idylla CDx MSI Test?

    The test reports MSI status as either Microsatellite Stable (MSS), Microsatellite Instability-High (MSI-H), or invalid. This classification helps determine potential treatment options for colorectal cancer patients.

  • Is the Idylla CDx MSI Test approved by regulatory authorities?

    The device has received FDA PMA approval, as indicated by the FDA_PMA authorization status and the decision code APPR with a decision date of 2025-08-15. It is classified as a Class III nucleic acid-based assay for microsatellite instability.