Module 18 - Drug Device Combinations and Other Technologies

30/11/2023

Its function screening, diagnosis, monitoring, prognosis, companion diagnostic , prediction

The International Non proprietary Name (INN) of the associated medicinal product

1

for which it is a companion test

6

TUse Specific information in the context of

What is detected and /or measured

5

2

Testing population

Prediction of treatment response or reactions

3

Type of specimens

4

1 5

Several CDx specific intended purpose requirements

The Organisation for Professionals in Regulatory Affairs

15

The KRAS PCR Kit is a real-time qualitative PCR test for the

detection of seven somatic mutations

2

(Codon 12: G12A, G12D, G12R, G12C, G12S, G12V, and Codon 13: G13D) in exon 2 of the human KRAS

gene using genomic DNA (gDNA) extracted from

specimens of formalin-fixed paraffin-embedded (FFPE)

4

human colorectal cancer (CRC) tumor tissue.

What is detected and /or measured

The (…) PCR Kit is indicated for use as a

companion diagnostic test, to aid clinicians in the

1

identification of patients

with metastatic colorectal cancer (mCRC) who are

less likely to respond

5

3

positively to treatment with the anti-EGFR biological therapeutics Erbitux (

cetuximab) or Vectibix

6

(

panitumumab), on the basis of a

KRAS Mutation Detected result.

2

6

Type of specimens

KRAS kit is a predictive marker of cetuximab efficacy KRAS wild-type tumors benefit from cetuximab

IVD CDx example

The Organisation for Professionals in Regulatory Affairs

16

8