
Personalis Data from TRACERx for MRD Test Appears on Par With Market Leader Natera
Personalis has announced new data from the TRACERx lung cancer study using its NeXT Personal cancer assay. The study found that the company’s test could enhance the detection rates of circulating tumor DNA (ctDNA) in early-stage lung cancer patients, particularly in cases of lung adenocarcinoma (LUAD), a challenging subtype of non-small cell lung cancer (NSCLC) to detect through blood samples. The announcement was made at the 2023 European Society for Medical Oncology (ESMO) Congress in Madrid, Spain. The study is part of an ongoing collaboration between Personalis and institutions like Cancer Research UK’s Cancer Research Horizons, University College London (UCL), and the Francis Crick Institute.
Lung cancer is a significant public health concern, being the second most common cancer in the United States with around 238,000 new cases and 127,000 predicted deaths. The standard method for relapse detection in NSCLC, the most common type of lung cancer, relies heavily on imaging modalities such as CT scans, which have known limitations in terms of sensitivity. The collaboration between these institutions is focused on addressing this challenge through advanced ctDNA analysis. To achieve this, the teams utilized the NeXT Personal cancer assay to identify and monitor minimal residual disease (MRD) in over 170 patients from the TRACERx study.
The NeXT Personal assay exhibited significantly higher sensitivity in early-stage NSCLC patients compared to prior studies on the TRACERx cohort. Notably, prior to surgery, the assay displayed 100% sensitivity for ctDNA in pre-surgical non-LUAD samples and 81% sensitivity for LUAD. This sensitivity was up to four times higher than in previous studies, depending on the stage of the cancer. This increased sensitivity greatly improved the assay’s capacity to detect recurrences and effectively monitor lung cancer.
One of the key outcomes of the study was the ability to categorize early-stage lung cancer patients into lower and higher recurrence risk groups based on pre-surgical ctDNA levels. Moreover, the analysis revealed that ultra-low levels of ctDNA detected by the NeXT Personal assay played a crucial role in assessing patient recurrence risk. For instance, LUAD patients who tested ctDNA-negative before surgery exhibited a remarkable 100% 5-year overall survival rate and a 94% relapse-free survival rate. In contrast, patients who tested ctDNA-positive prior to surgery had a considerably higher risk of cancer recurrence over a 5-year period.
Additionally, the results indicated that NeXT Personal allowed for the earlier detection of residual or recurrent lung cancer after surgery, with a median lead time of approximately 6 to 11 months compared to traditional imaging. This is a significantly longer lead time than previous TRACERx results, providing a valuable window of opportunity for the intervention and accelerated treatment of high-risk patients.
The NeXT Personal assay leverages whole genome sequencing and advanced noise suppression technology to identify a unique genetic signature derived from a patient’s tumor. This signature is then tracked in the patient’s blood over time to detect residual or recurrent cancer with an industry-leading sensitivity of down to approximately 1 PPM (parts per million).
The data is similar to data presented by market leader Natera in NSCLC. Natera’s minimal residual disease test Signatera. In their studies, data showed that patient’s who cleared ctDNA (>90% at 9 weeks) had 96% improved survival relative to patients who did not and they also showed the ability to detect recurrence 5-6 months prior to imaging.
Personalis’ Chief Medical Officer and Executive Vice President of R&D, Dr. Richard Chen, expressed the company’s commitment to developing more sensitive tests for lung cancer patients. He believes that the enhanced sensitivity of the NeXT Personal assay can save lives by offering early detection and improving the chances of successful intervention.