Oncology
Making precision oncology more attainable
Progress in advanced molecular diagnostics could make precision oncology more accessible earlier in the cancer patient journey. Simon Forbes and Laurie Clarke look at key technologies and regulatory developments that demonstrate the potential of liquid biopsy genetic testing.
Precision oncology is creating a new paradigm in medicine, and liquid biopsy genetic tests offer ways to make precise cancer diagnosis simpler and quicker too. Together, these capabilities could transform diagnosis and treatment pathways, delivering better outcomes for individual patients and across populations. In recent years, several liquid biopsy genetic tests have enjoyed regulatory success, potentially paving the way for a broader range to gain market authorisation. So, what technical considerations do innovation teams need to be aware of, and what are the regulatory milestones that will shape the path ahead?
Liquid biopsy genetic tests and cancer diagnosis Most cancers are caused by the acquisition of genetic mutations over time. This can be accelerated by factors like smoking, or exposure to sunlight or asbestos. Key mutations act together to encourage pathological cell growth,
and DNA sequencing has been used to identify these for many years. A patient’s disease is characterised based on the genetic mutations found, and the mutations also define the applicable clinical treatments. Currently, a patient is usually referred to an oncology clinic after cancer symptoms are spotted, with genetic testing applied after imaging and surgery to remove a biopsy sample. Unfortunately, these slow and expensive processes are often applied when a patient is in the later, less survivable, stages of disease. Liquid biopsy genetic tests use a blood sample
instead of a tissue biopsy, making it easier to conduct genetic testing earlier in the patient journey. These tests build on the specificity of genetic sequencing technologies, creating a new market of low-cost, high-speed tests. Significant opportunities exist in this early maturing market, from pre-symptomatic cancer detection to precise therapy recommendations.
Using ctDNA to aid cancer diagnosis Circulating tumour DNA (ctDNA) tests offer great potential to accelerate patient diagnosis. During cancer growth as tumour cells are replaced and die, they release DNA into the bloodstream. This DNA can be interrogated using next-generation sequencing (NGS) technology, highlighting mutations that are causing disease. Applying these low cost, fast tests sooner allows physicians to detect cancer patients at an early stage. It also enables them to make treatment decisions, monitor treatment response, predict relapses and metastases, unravel tumour complexity, and detect very low levels of residual disease, as well as reassuring people who are disease-free. All the above factors improve efficiency and
reduce the need for clinical visits. They also contribute to improved patient outcome and quality of life given the disease isn’t allowed to progress as far. Making liquid biopsy genetic testing more accessible to more people will create new opportunities for precision oncology. Its use can reduce the average cost and impact of cancer across population healthcare as well as for individuals. The core scientific and technological capabilities for this diagnostic capability already exist, and an exciting range of entrepreneurial activity is exploring its deployment potential. Recent FDA approvals indicate that the regulatory environment is favorable too. Future developments will likely focus on ways to improve the sensitivity, speed and price of the tests, aiming to detect disease quicker and earlier to reduce its impact on individual patients and healthcare providers.
How ctDNA enables precision oncology In precision oncology, the genetic mutations found in tumours are used to direct therapy. For instance, epidermal growth factor receptor (EGFR) mutations found in lung cancer require treatment with tyrosine kinase inhibitors
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