Synchronized evaluation process for companion diagnostic tests


Personalized medicine and its associated research are booming. The advent of more and more targeted treatments calls for the use of biomedical testing to identify people who could potentially benefit from them. INESSS therefore seeks to implement all of the processes required to ensure that the companion diagnostic test for a listed drug with recognized therapeutic value can be available in a timely fashion, where applicable.

INESSS defines “companion diagnostic test” as a diagnostic test [or a pharmacogenetic test or a test allowing therapeutic follow-up] enabling the selection of patients based on the status of a predictive marker detected by this test. Selected patients are those for whom the treatment is likely to provide a benefit among all those diagnosed with a given illness. The test is then considered to be a "companion" to the use of the treatment.

- definition partially taken from the Haute autorité de santé (HAS)1

Synchronized evaluation process for companion diagnostic tests

The goal in implementing an evaluation process for companion diagnostic tests is to ensure the Direction de la biovigilance et de la biologie médicale (DBBM) of the MSSS is informed in a timely fashion that a medical biology analysis is associated with a drug being evaluated by INESSS. Consequently, when a notice is sent to the Minister recommending the listing of a drug associated with a companion diagnostic test, the authorities responsible for adapting laboratory services can take the necessary steps to ensure the availability of said analysis upon listing of the drug.

For manufacturers
The synchronized evaluation process for companion diagnostic tests only applies to analyses associated with a drug being evaluated for listing purposes. Any application requesting listing to the Répertoire of an analysis not associated with a drug under evaluation is subject to the two-stage Assessment mechanism for medical biology tests.

The synchronized evaluation process for companion diagnostic tests is linked to the INESSS evaluation of drugs for listing purposes process. If applicable, manufacturers are required to inform INESSS, in the mandatory advance notice, that a test has been associated with the drug referred to in the application for evaluation for listing purposes.2 In addition to this mandatory advance notice, the manufacturer will need to file a submission for companion diagnostic tests evaluation with INESSS.

Terms and conditions
The manufacturer is expected to provide the following information:

  • Name of drug;
  • Name of manufacturer;
  • Indications requested in application to INESSS;
  • Context;
  • Objectives of companion diagnostic test;
  • Recommended technique(s);
  • Current status of laboratory service;
  • Budgetary aspects related to the companion diagnostic test.

Procedure for submitting a companion diagnostic tests evaluation file

Evaluation process and criteria for companion diagnostic tests

If the therapeutic value of the drug is recognized by INESSS upon completion of the evaluation of drugs for listing purposes process, the ministerial authorities responsible will ensure that laboratories are able to offer the companion diagnostic test when the drug is listed.

1Definition taken from the Methodological Guide titled Companion diagnostic test associated with a targeted therapy: definitions and assessment method – February 2014, available on the HAS website.

2The INESSS website and the documents manufacturers are asked to submit were updated on February 16, 2018.

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