As approaches to treating cancer continue becoming more targeted, companion diagnostics (CDx) have an increasingly important role to play in oncology, an expert has said.
Forecasting that the overall diagnostics market in oncology will be worth more than $3.1bn by 2030, up from $1.9bn in 2022, GlobalData鈥檚 recent reveals that oncology is currently the top indication both for pipeline and marketed CDx devices.
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In oncology, accurately determining patient eligibility for targeted therapies can significantly improve treatment efficacy.
Russell Bradley, president and general manager of rare cancer assay developer CNSide, told 吃瓜黑料网 Network: 鈥淚ncreasingly targeted approaches to treating cancer require precise targeting tools to facilitate the best match between a specific patient and the optimal therapeutic strategy. This is where CDx is a critical component of the overall assessment.
鈥淚 expect this interconnectedness between targeted cancer therapies and precision diagnostics to accelerate, driven by the development of more effective and personalised therapies.鈥�
Bradley notes, however, that for diagnostic test developers, challenges remain in implementing CDx tools, including high bars towards obtaining regulatory approval.
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By GlobalDataBradley said: 鈥淪uch a process can prove expensive and time-consuming for the diagnostic developer or partner, especially with the large risk/reward disparity between the therapeutic developer and the diagnostic partner.
鈥淚n some scenarios, the business case for the diagnostic developer is marginal when considering inputs such as time to market, regulatory burden, capped reimbursement, and perhaps a small overall diagnostic market opportunity for the therapeutic indication.鈥�
In a significant victory for the in vitro diagnostic (IVD) and, in turn, the CDx space, a Texas judge put paid to the US Food and Drug Administration鈥檚 (FDA) plans to regulate IVDs (otherwise known as laboratory-developed tests [LDTs]) as medical devices in April 2025.
The court case related to the FDA鈥檚 鈥楩inal Rule.鈥� Issued in May 2024, it asserted that IVDs were medical devices and would therefore be regulated under the same standards. The move, which meant that IVDs would have been subject to the same pre-market authorisation and post-market surveillance dictates of medical devices, prompted widespread backlash in the diagnostics space.
Following the rule being struck down, Susan van Meter, president of the American Clinical Laboratory Association (ACLA), one of the organisations that filed the original lawsuit, said: 鈥淭his is a victory that protects patient access to critically needed testing services and removes burdensome regulations that would have undermined the clinical laboratory system in this country.鈥�
