The diagnostic approval process is an essential part of the commercialization and regulation of novel tests. Tests have to be approved for use by regulatory authorities and getting that approval can be a lengthy and complex process. This is made more complicated by the fact that different global regions enforce their own processes, and these regulations are constantly evolving. It is, therefore, critical for pharma companies to understand the approval timeframes for both therapies and tests, to facilitate effective strategic planning. Submitting a diagnostic and therapy for simultaneous review can significantly shorten the regulatory process and thereby get your test into the marketplace much earlier. However, this takes forward thinking and a detailed knowledge of global regulatory procedures in this fast-evolving space, all of which Diaceutics can support. More regulatory authorities, including the FDA, are now encouraging co-appraisal of the therapeutic with the diagnostic, which is a positive development for a well-prepared pharma company.
In Europe, all in vitro diagnostics (IVD) must be CE-marked before being placed on the market. This proves the test meets the requirements of applicable European Community directives. Other countries, such as Japan and Brazil, have their own regulatory approval processes. In addition to national differences in diagnostic approvals, there can be designated routes for different tests within a regulatory jurisdiction. Most companion diagnostics are likely to need a more rigorous review which will take more time and require more evidence to support regulatory approval. In the US, there are two routes for diagnostic regulation - the 510k pre-market notification and the PMA pre-market approval. So you may have a brand new diagnostic that needs to be approved by a different method in several different markets. It’s complicated.
Then there are the changes taking place as regulatory authorities continue to assess and update their procedures. Efforts in the US to regulate laboratory developed tests, or LDTs, have been ongoing for some time and have been further delayed in 2017. Change is also afoot in Europe as the IVD Directive is being replaced with the IVD Regulation which will have significant repercussions for tests already in use and the laboratories that run them.
The introduction of the FDA Breakthrough Designation for novel therapies places a heavier burden on streamlining the co-development and regulatory alignment of the therapy and companion diagnostic. There has been a significant increase in the number of joint submissions being approved as a result. Recent companion diagnostics co-developed with the therapy have had successful PMA reviews (and granted FDA priority status) and been approved in less than six months. For example, BRACAnalysis (the diagnostic for Lynparza) was cleared in just three months. Therapy and diagnostic combinations can be co-approved by the FDA on the same day, so a well-planned submission can put a pharma company in a good position.
Pharma companies cannot change the regulations with which their products need to comply, but they can contribute to a speedier diagnostic approval by ensuring their test is being developed in alignment with the therapy so that it is ready for a simultaneous approval and launch. Diaceutics recognizes that the diagnostic is as important as the therapy and it should be integrated into the whole commercialization process. That way, when a therapy comes to market, the diagnostic to test for suitable patients will be ready to use and those patients will get their targeted therapy at the right time, which may save their lives.