Cutting Clinical Costs with Companion Diagnostics

Advancing personalised medicine has become a key goal for many pharma firms, evident from the rising number of such therapies under clinical development. In 2022 alone, 12 new personalised medicines were approved, marking these treatments as accounting for at least a quarter of new drug approvals over the past eight years. This contrasts sharply with a decade ago when personalised medicines constituted less than 10 per cent of new approvals annually, according to The Personalised Medicine Coalition report. As the trend towards precision medicine and targeted therapies continues, companion diagnostics (CDX) are becoming increasingly vital, particularly in oncology. Let's explore the opportunities that CDX presents and the hurdles in their development and implementation.

- Ayesha Siddiqui

Companion diagnostics (CDx) are the cornerstone of precision medicine and play a critical role in optimising patient outcomes and reducing healthcare costs by ensuring that therapies are tailored to individual patient profiles. Currently, there are 51 CDx tests approved by the US Food and Drug Administration (FDA). The majority of these are for haematological malignancies and solid tumours. In fact, of the 170 approved indications listed on the FDA website for companion diagnostics, only three are for nononcology drugs.

In addition to their role in personalised medicines, CDx can also enhance clinical trials and expedite drug development by pinpointing appropriate patient populations. Research and Markets indicates that CDx-guided drug development has the potential to cut clinical trial costs by up to 60 per cent. This allows pharmaceutical companies to bring proven drugs to market more quickly and at a lower cost through clinical trials. That's why there has been a rise in partnerships between pharmaceutical companies and diagnostics firms. Notable examples include Incyte’s collaboration with Agilent on CDx development, Foundation Medicine’s partnership with Repare Therapeutics to provide genomic profiling services and develop CDx., Additionally, there's Roche and Janssen’s strengthened collaboration to develop CDx tests for targeted therapies.

Challenges in CDx development

There are several key stages involved in developing a CDx test all of which must be synchronised with drug development. “CDx development and commercialisation processes are rigorous and involve close alignment across multiple stakeholders, which can make meeting clinical timelines a big challenge. Navigating the complex and evolving regulatory landscape across different regions can also delay approval and implementation,” said Karina Kulangara, Associate Vice President, R&D, Companion Diagnostics at Agilent Technologies.