Liquid biopsy genetic tests are making precision cancer diagnostics simpler and quicker than ever before. Using a blood sample instead of a tissue biopsy, they 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 precise therapy recommendations to pre-symptomatic cancer detection. Recent regulatory successes have seen these technologies begin to appear in the market, with an increasingly broad range of entrepreneurial products almost ready to emerge. In this paper, we join forces with our sister company TSG Consulting to outline technical considerations and regulatory milestones that will shape the path ahead.

Most cancers are caused by the acquisition of genetic mutations over time, this can be accelerated for instance through 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.