Msac application 1173

Regulatory status

An assay designed for EGFR gene mutation testing is classified as an in vitro diagnostic medical device (IVD). IVDs are, in general, pathology tests and related instrumentation used to carry out testing on human samples, where the results are intended to assist in clinical

diagnosis or in making decisions concerning clinical management (Therapeutic Goods

Administration 2009).

The Therapeutic Goods Administration (TGA) regulatory framework for IVDs changed in July

2010. All IVDs now require premarket approval by the TGA (unless they were offered prior to July 1 2010 in Australia where a transition period up to 2014 applies). The new framework also requires all in-house assays (laboratory developed tests) to also be subjected to a review. Class 4 in-house assays now receive the same level of regulatory scrutiny as commercial kits. EGFR gene mutation testing is a Class 3 IVD and as such is subject to the National Pathology Accreditation Advisory Committee (NPAAC) standard for in-house assays. This provides some oversight (as assessed by NATA audits) by professional peers but it is not subject to the same vigour as commercially available Class 3 IVDs. EGFR gene mutation tests provided as in-house IVDs would be classified as Class 3 in-house IVDs that will require each performing laboratory to obtain NATA approval for their respective laboratory developed test (see Figure 1).