Member views sought on TGA’s companion diagnostic guidance update

AusBiotech is seeking feedback on the Therapeutic Goods Administration (TGA)’s updated draft Companion Diagnostics (CDx) Guidance document to form an industry-led response.

The proposed updates aim to provide sponsors and manufacturers of medicines, biologicals and in vitro diagnostics (IVD) medical devices further clarification regarding the requirements for companion testing, including:

  • A CDx testing identification guide to assist them in identifying whether their medicine or biological indication requires companion testing,
  • An introduction to the concept of the ‘companion testing plan’ to recognise the CDx component evaluations undertaken as part of the medicine application,
  • Improved clarity on clinical and analytical performance requirements for CDx, and
  • Case studies to assist sponsors of medicines and devices on the regulatory process and the technical documentation required for an IVD CDx.

Companion diagnostics are tests or assays that help identify patients who are most likely to benefit from a particular treatment or medication. For every clinical indication of medicine, where IVD testing is essential for safe and effective use of that medicine, there are multiple factors that may determine the level of regulatory oversight of these devices.

According to the TGA, and consistent with the regulatory definition, a CDx is an IVD that is essential for the safe and effective use of a corresponding medicine or biological, where both:

  • the Product Information (PI) for the medicine (or Instructions for Use [IFU] for the biological) states that CDx testing is essential for the relevant use of the medicine or biological to be safe and effective, and
  • the IVD claims that it is intended for the relevant use of the medicine or biological.

As the wording of the medicine or biological PI and the IFU are determined during the medicine registration process, the TGA has developed the CDx testing identification guide to help identify whether a proposed medicine or biological indication requires CDx testing, independently of PI or IFU wording. The testing identification guide can be found in the draft guidance document here.

The intention of the identification guide is to assist in identifying tests that require inclusion in the Australian Register of Therapeutic Goods (ARTG) under the CDx framework for supply in Australia. This is to ensure the analytical and clinical performance of devices that are intended to conduct such testing are appropriate for use in conjunction with that medicine or biological.”

Importantly, the guidance document includes four case study examples that may assist device sponsors in understanding clinical and analytical requirements when submitting a CDx application.

AusBiotech, with the support of its AusMedtech Regulatory Affairs Advisory Group (AMRAAG), intends to make an industry-led submission, subject to member feedback.

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