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European Pharmaceutical Contractor

Testing Times

Existing drugs (Rx), their diagnostic (Dx) combinations, and the strong pipeline of some of the major in vitro diagnostics (IVD) firms are fuelling the growth of personalised medicine. The majority of these combination products have a strong focus on oncology, while other areas such as infectious disease and neurology-based combinations have entered the market from 2011 onwards. A number of pharmaceutical companies are interested in acquiring and partnering with IVD firms, and this surge in mergers and acquisitions is a testimony to the strong appetite for companion diagnostic (CDx) products.

Key Drivers and Challenges

This demand is being driven by many worldwide payers and regulators who stress the importance of diagnostics and biomarkers, which will eventually bring down healthcare treatment costs. Despite the gearup of combination products, their future potential is still affected by reimbursement practices.

Regulatory Outlook

Regulatory guidelines vary considerably across the US and Europe. The Food and Drug Administration (FDA) requirements are different from the European Medicines Agency’s (EMA’s) – the latter specifies the approved drug must be followed by the CDx product in testing, while the former requires the biomarker to be tested first. Although the EMA emphasises their co-development, key opinion leaders believe that the EMA is yet to play an active role in phrasing guidelines for CDx products.

The European Commission (EC) is prompting companies to explore the opportunities for CDx products during the development of the drugs themselves. The EC has also been encouraging small manufacturing enterprises by offering support to reduce the cost of developing innovative products.

The current framework is provided by Directive 98/79/EC; the new regulation is expected to start in 2014 and is in accordance with Global Harmonization Task Force guidelines. It is expected that the new EU IVD regulations will introduce significant changes, and this will, in turn, affect the costs associated with new product launches and the pipelines of major industry participants. Substantial changes are expected in the risk classification system with special requirements for CDxs and point-of-care testing. The current procedure for testing combination products is quite informal.

According to the current IVD directive, Rx-Dx products are classified as low-risk – hence, most of the manufacturers tend to self-assess conformity and self-certify CDx products, and project a CE mark to become available in the European market. Nearly all diagnostic tests in Europe are classified as low-risk and, therefore, are exempt from pre-market evaluation. This works well as it means a higher rate of approval for new tests and products in the region. At the same time, however, lack of procedure may make it difficult to gain approval in other markets. Although there is a general consensus about the demonstration of clinical utility of CDx drug diagnostic combination products, there is no clear clarity and a lack of evidence in proving the clinical validity of tests.

Laboratory-developed tests (LDTs) is a vast market and proving to be a grey area in Europe, as they tend to compete with IVD products. These tests are offered through reference laboratories worldwide and a few businesses have partnered with European companies to work on patient samples and report the results to the patient. Some of the European organisations that are marketing LDT tests in Europe include Agendia B.V. (Mammaprint test), Nanostring Technologies (Prosigna test) and Medical Solutions UK (OncotypeDx). The future European IVD directive and the FDA intend to keep a close watch on the release of LDT products and regulate them more efficiently.

Future Solutions

Gaining reimbursement is a challenge for newly approved tests in many countries. A consensus needs to be achieved globally across all health technology assessment models to enable a faster decision. When most pharmaceutical IVD partnerships are aiming for the co-development of a drug and diagnostic combination together, an average delay of four to seven years can contribute towards a loss for the manufacturing firm. Network groups like the European network for Health Technology Assessment and Center for Medical Technology Policy in the US are working on a cooperative model in order to encourage a favourable decision, but it remains to be seen what will, in fact, be put into practice.


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Divyaa Ravishankar is a Senior Research Analyst in the European Healthcare Practice at Frost & Sullivan. She has diverse expertise within healthcare, IT and life sciences, which mainly consists of laboratory research and management consulting. Divyaa has industry experience covering a broad range of sectors, leveraging long-standing working relationships with leading industry participants in areas such as clinical diagnostics, pharma and biotech companies. She holds an MSc in Biological Sciences from Birla Institute of Technology and Science, Pilani, India.
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Divyaa Ravishankar
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