TEST:

NeXT Personal™

"Personalis, Inc...announced new data from an AstraZeneca phase 3 clinical trial in lung cancer (NeoADAURA). The findings demonstrate that Personalis’ highly sensitive molecular residual disease (MRD) test, NeXT Personal®, is a strong predictor of outcomes in patients with stage II-IIIb, EGFR-mutated non-small cell lung cancer (NSCLC) receiving neoadjuvant therapy."

"Personalis, Inc. (Nasdaq: PSNL) today announced an expansion and extension of its strategic collaboration with Tempus AI, Inc. (Nasdaq: TEM), adding a new indication, colorectal cancer (CRC), to the existing, exclusive commercialization agreement. The update means Personalis and Tempus will now work to bring to market the NeXT Personal® ultra-sensitive, tumor-informed minimal residual disease (MRD) test to detect cancer recurrence in four areas: breast, lung and colorectal cancers, and solid tumor immunotherapy monitoring. The addition of CRC follows the presentation of compelling interim analysis results from the VICTORI study at the 2025 American Association for Cancer Research (AACR) Annual Meeting, which demonstrated strong performance of NeXT Personal for detecting early signs of residual or recurrent CRC."

This study demonstrates the potential utility of ultrasensitive detection of ctDNA as a predictive and prognostic marker of disease progression and OS in LACC independent of disease stage.

"Personalis, Inc...announced multiple presentations at the American Society of Clinical Oncology (ASCO) Annual Meeting next week in Chicago, Illinois. The presentations feature new data from clinical studies utilizing the NeXT Personal® ultrasensitive ctDNA assay for residual and recurrent cancer detection...The presentations are...Circulating tumor DNA, pathologic response after neoadjuvant therapy, and survival: First results from TBCRC 040 (the PREDICT-DNA trial)...Ultrasensitive detection and tracking of circulating tumor DNA (ctDNA) and association with relapse and survival in locally advanced cervical cancer (LACC): Phase 3 CALLA trial analyses...Ultrasensitive circulating tumor DNA (ctDNA) detection for prognostication in triple-negative breast cancer (TNBC) post-neoadjuvant chemotherapy (NAC)...Ultrasensitive ctDNA monitoring to reveal early predictors of immunotherapy success in advanced cancer"

"Personalis...today announced new interim analysis results of the VICTORI study showing strong performance of its ultra-sensitive NeXT Personal assay in detecting early signs of residual or recurrent colorectal cancer (CRC)....The data was presented at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, Illinois by Emma Titmuss at BC Cancer, in an oral presentation titled Detection of post-surgical minimal residual disease (MRD) in colorectal cancer; preliminary results from the VICTORI study."

"Personalis...today that two oral presentations and a poster presentation featuring data for the company’s NeXT Personal® ultrasensitive ctDNA assay for residual and recurrent cancer detection will be presented at the American Association for Cancer Research (AACR) Annual Meeting April 25-30, 2025 in Chicago, Illinois."

P=NA | N=78 | "In this study, NeXT Personal was used to analyze blood samples from a cohort of 78 patients with early-stage breast cancer. The cohort included patients with triple-negative breast cancer (TNBC), HER2+, and HR+ breast cancers. The NeXT Personal test showed high sensitivity for detecting early-stage breast cancer with ~39% of all detections occurring in the ultra-sensitive range below 100 PPM, demonstrating the test’s ability to detect exceedingly small traces of cancer in the blood. The test detected 100% of the patients that had breast cancer recurrence, a median of ~15 months and up to 5 years ahead of standard of care radiographic imaging. Importantly, 100% of patients who tested negative with NeXT Personal throughout the study period remained disease-free."

A whole genome powered MRD assay detected breast cancer relapse with a long lead-time over clinical relapse, and strongly associated with relapse free survival. Rates of ctDNA detection at diagnosis were higher than those reported with exome-based tumour informed assays.

ctDNA predicted worse clinical outcome, and patients with LUAD with <80 ppm preoperative ctDNA levels (the 95% limit of detection of a ctDNA detection approach previously published in TRACERx) experienced reduced overall survival compared with ctDNA-negative patients with LUAD. Although prospective studies are needed to confirm the clinical utility of the assay, these data show that our approach has the potential to improve disease stratification in early-stage LUADs.

P=NA | N=NA | "Personalis, Inc...published new results from their TRACERx lung cancer study in Nature Medicine....The NeXT Personal test showed high sensitivity for detecting early-stage I-III NSCLC pre-operatively, including 100% of non-adenocarcinomas and 81% of lung adenocarcinomas (LUAD), a common subtype that has previously been one of the most challenging to detect in blood samples because of low ctDNA shedding. The publication also showed ctDNA levels prior to surgery were highly prognostic for overall survival in early-stage LUAD patients. Early-stage LUAD patients who tested negative for ctDNA with NeXT Personal prior to surgery exhibited a 100% 5-year overall survival rate while patients testing positive had a high overall risk of relapse during that same period."

P=Obs | N=814 | TRACERx (NCT01888601) | "Personalis...announced findings presented this week at the European Society of Medical Oncology Congress...In the first of these studies, Professor Charles Swanton and his colleagues...analyzed over 400 non-small cell lung cancer (NSCLC) patients from their TRACERx lung cancer study, using the NeXT Personal assay...A high percentage of these landmark detections (42%) occur in the ultrasensitive range (less than 80 ppm) enabled by NeXT Personal...In the second abstract, Dr. Rodrigo Toledo...presented data on a large cohort of over 200 late-stage cancer patients on immunotherapy profiled using the NeXT Personal assay, significantly expanding on the initial cohort first presented earlier this year. The study was unique in having a validation set of patients and it demonstrated that patients who had a significant decrease in ctDNA levels in response to immunotherapy had significantly longer overall survival than those who did not."

Early ctDNA dynamics determined by ultra-sensitive assay are predictive of long-term ICI response in the advanced, pan-cancer setting. ctDNA analyses emerges as a potential clinically useful tool for dealing with the ICI-related pseudoprogression phenomena.