The availability of a new therapy is often the primary driver for diagnostic adoption. For Lynch syndrome, many at-risk individuals don't get tested because there's no preventative treatment. Newscom believes its therapy will create a strong incentive for genetic testing, mirroring how checkpoint inhibitors drove a 5x increase in MSI screening.

Beyond early discovery, LLMs deliver significant value in clinical trials. They accelerate timelines by automating months of post-trial documentation work. More strategically, they can improve trial success rates by analyzing genomic data to identify patient populations with a higher likelihood of responding to a treatment.

Shifting from clinician-ordered to pathologist-initiated reflex testing for NSCLC biomarkers combines diagnosis and molecular analysis into one workflow. This operational change minimizes delays, increases testing rates, and optimizes the use of small biopsy samples, getting actionable results to oncologists faster.

Advanced biomarkers are no longer just research tools. Tools like Decipher provide results within a week from a shipped sample, and Artera's MMEI simply requires scanning a pathology slide. This practicality allows clinicians to personalize treatment intensification for high-risk patients in current clinical workflows, moving beyond purely clinical risk factors.

An analysis of over 17,000 oncology drug development trajectories revealed that trials incorporating biomarkers had almost twice the overall success probability (10%) compared to those without (5%). This success boost is most significant in early-phase (Phase 1 and 2) trials.

Establishing a multi-disciplinary molecular tumour board helps operationalize biomarker strategies. This collaborative body, including oncologists and surgeons, not only interprets complex molecular data for trial matching but also collectively advocates for health insurance reimbursement for necessary tests, addressing a key practical barrier.

For certain therapies like Enhertu, eligibility is based on immunohistochemistry (IHC), not NGS. Labs must run HER2 IHC in parallel because NGS, as a population-based test, can miss intratumoral heterogeneity (small clusters of positive cells) that IHC can detect, thus identifying more eligible patients for targeted therapy.

Clinicians increasingly perform Next-Generation Sequencing (NGS) on initial diagnostic tissue, even if results don't alter first-line treatment. This proactive approach identifies stable mutations like PIK3CA early, enabling long-term planning, such as optimizing a patient's metabolic health in anticipation of future targeted therapies.

Regeneron's Genetics Center is a key competitive advantage, functioning as a discovery engine for new drug targets. By sequencing millions of patient genomes and linking them to health records, it allows Regeneron to identify novel genetic variants associated with diseases, feeding its antibody development pipeline with proprietary targets.