Idylla™ CDx MSI Test

Organization name

Biocartis NV

SRN

BE-MF-000003661

Manufacturer status

Active

Primary placement in Belgium; available across 32 countries total.

Trade name

Idylla™ CDx MSI Test

UDI-DI code

15415219001328

Basic UDI-DI

5415219A0220BV

Reference / catalog number

A0220/6

Issuing entity

GS1

Risk category

IVDR Class C

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

6

Additional product description

The Idylla™ CDx MSI Test is an in vitro diagnostic test intended for the qualitative detection of a novel panel of seven (7) monomorphic biomarkers for identification of microsatellite instability (MSI) in colorectal cancer tissue. The Idylla™ CDx MSI Test uses formalin-fixed, paraffin embedded (FFPE) tissue sections from human colorectal cancer (CRC), from which nucleic acids are liberated, then analyzed by PCR amplification and high-resolution melting detection. The Idylla™ CDx MSI Test automates the entire process from FFPE specimen processing to reporting of MSI status as either Microsatellite Stable (MSS) or Microsatellite Instability-High (MSI-H). The Idylla™ CDx MSI Test is intended for identification of adult patients with MSI-H metastatic CRC, for whom treatment with OPDIVO® (nivolumab) in combination with YERVOY® (ipilimumab) as a combination therapy is indicated with approved therapeutic product labeling.

Additional information URL

https://www.biocartis.com/ifu

Clinical sizes

No clinical sizes registered for this device.

• W01060214COLORECTAL CANCER (MSI-H / DMMR)

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification