Personalis operates a large, FDA-compliant facility in Fremont, CA, processing 100,000 samples annually with plans to expand to 300,000. They are CLIA and CAP accredited and have partnerships with biopharma companies and cancer centres globally.
Christelle Johnson first discussed the company’s products. Personalis offers a tissue immunogenomic profiling technology called ImmunoID NeXT, a combined exome and transcriptome assay which provides a comprehensive suite of DNA and RNA biomarkers from the tumour microenvironment.
The company’s flagship product is NeXT Personal: a liquid biopsy tumour-informed MRD assay with industry-leading sensitivity. This whole genome based assay is offered for immuno oncology research applications and for diagnostic laboratory developed tests (LDTs) in the US. It was this technology that Johnson spent the rest of her presentation discussing.
The NeXT Personal first performs whole genome sequencing on tumour and normal tissues, the data from which informs the selection of up to 1800 high-quality targets. These targets make up the personalised MRD signature for the patient. Personalis can then manufacture a personalised panel with ctDNA probes based on the patient’s signature. The panel can be used to profile the patient’s plasma at timepoints throughout their treatment protocol.
The assay has demonstrated over 99.9% analytical specificity and 100% sensitivity, capable of detecting one mutant molecule per million in plasma samples. It adheres to rigorous guidelines for validation and analysis. NeXT Personal can detect ctDNA signals, providing actionable insights for patient management, especially in early-stage cancers like non-small cell lung cancer and breast cancer.
Johnson then outlined some insights from the TRACERx clinical study for non-small cell lung cancer. This study showcased the assay's ability to detect ctDNA in 81% of patients at baseline, significantly outperforming other technologies, particularly in stage 1 adenocarcinoma patients. One important outcome was the fact that the assay could identify ctDNA signals up to six months before traditional imaging methods, offering critical lead time for clinical intervention.
Furthermore, looking at an early-stage breast cancer study, NeXT Personal achieved a 39% detection rate in the ultra-sensitive range, demonstrating its effectiveness in monitoring treatment responses. The NeXT Personal assay represents a significant advancement in cancer monitoring, providing high sensitivity and early detection capabilities that can improve patient outcomes.
