Personalis, Inc.

We recently presented new data from the NeoADAURA global cancer trial showing the superiority of ultrasensitive, tumor-informed minimal residual disease (MRD) testing using NeXT Personal®. In an interview with GenomeWeb's Molika Ashford, Richard Chen, Chief Medical Officer and EVP of R&D at Personalis spoke about the data from the AstraZeneca phase 3 clinical trial: “The current results [from the interim analysis] confirm that the company's platform can track and monitor neoadjuvant treatment response in EGFR-mutant NSCLC, which…is known to be a challenging tumor type.” Dr. Chen went on to note: “It was clear from the trial results that baseline ctDNA positivity was highly prognostic in and of itself, supporting the hypothesis that it could help guide treatment decisions.” Key findings from the analysis, include: • More sensitive: NeXT Personal demonstrated significantly higher baseline (pre-treatment) sensitivity for ctDNA detection (71%) compared to a plasma-based EGFR mutation test (30%). • Prognostic: Baseline MRD status, as determined by NeXT Personal, was a strong prognosticator of clinical outcomes across all treatment arms.  • Patients with baseline ctDNA not detected had 96% event-free survival (EFS) at 18 months • Patients with detectable baseline ctDNA were 4 times more likely to experience an event than undetectable baseline ctDNA patients (EFS Hazard ratio for ctDNA- vs ctDNA+ was 0.24 [95% CI 0.07, 0.80]) • Useful for monitoring treatment: Osimertinib-containing regimens improved pre-surgical MRD clearance vs placebo + chemotherapy, showing the utility of ctDNA for monitoring neoadjuvant therapy response.   Read the article to hear more from Dr. Chen: https://bit.ly/46ikz3h #PrecisionMedicine #PrecisionOncology #LungCancer #NSCLC #MRD #ctDNA #NeoADAURA

Our team is excited to be in Boston next week for #WorldCDx! If you are planning to attend, join us for an informative session highlighting NeXT Personal® for ultrasensitive ctDNA detection led by Stephane Mouradian, PhD, SVP of Business Development at Personalis, on day 2, Wednesday, September 24th at 8:30AM. The session title is “Harnessing the Power of Ultra-Sensitive ctDNA Detection for Molecular Response & Endpoint Across All Phases of Clinical Development.” We look forward to meeting you! Reach out to us here to schedule time to meet at World CB & CDx: https://bit.ly/4goxSSO #PrecisionMedicine #PrecisionOncology #ClinicalDiagnostics #CompanionDiagnostics #CDx #Biomarkers Molly Hurley, Carrie Browning, Julie Meyer, Dan Nicolson, Stephane Mouradian, Dan Norton, MBA, Mafer Zuleta, Matthew M., Travis Yates

ICYMI: Last week we announced a collaboration with a leading breast cancer team from Yale Cancer Center for the CATE clinical trial, a novel ctDNA-guided study aimed at improving outcomes in patients with breast cancer. The prospective, multi-center trial, sponsored by the Translational Breast Cancer Research Consortium (TBCRC) and led by Dr. Mariya Rozenblit and Dr. Maryam Lustberg at Yale Cancer Center, will investigate whether earlier, ultrasensitive ctDNA-guided intervention can prevent metastatic relapse and improve outcomes for patients with HR+/HER2- breast cancer. HR+/HER2- breast cancer, which accounts for over 70% of all cases, poses a significant challenge due to the risk of late recurrence.   The CATE trial utilizes the NeXT Personal® test to identify the earliest molecular signs of recurrence, ahead of standard imaging. Patients who test positive will be preemptively treated with elacestrant, a next-generation therapy, with the goal of eliminating cancer before it becomes metastatic. Learn more from the press release: https://bit.ly/4grSkT0   See what’s being said in the news about this pivotal trial: https://bit.ly/4pwujym #PrecisionOncology #ctDNA #BreastCancer #ClinicalTrials #PrecisionMedicine #NGS

Our team will be in Boston for the 15th anniversary of the World CB & CDx Summit from September 22-25! This event will bring together industry leaders in #PrecisionMedicine to review the latest clinical studies, global regulatory shifts, and harmonized commercialization strategies shaping the future of personalized care. Reach out to us here to schedule time to meet at World CB & CDx: https://bit.ly/4goxSSO #PrecisionMedicine #PrecisionOncology #ClinicalDiagnostics #CompanionDiagnostics #WorldCDx #CDx #Biomarkers

Our team is ready for #WCLC25! Stop by booth # 424 if you’re attending World Lung, and learn about results from the Lung TRACERx study utilizing NeXT Personal® published in Nature Medicine earlier this year, and more! Additionally, visit a podium presentation from one of our partners, AstraZeneca, as they highlight MRD analysis from NeoADAURA: neoadjuvant osimertinib ± chemotherapy in resectable EGFRm non-small cell lung cancer (#NSCLC) on September 7th, 12:12PM (Room 06). Reach out to us to schedule time to meet at WCLC25: https://bit.ly/4m81zZP #PrecisionOncology #MRD #ctDNA #WCLC25 #LungCancer #ClinicalTrials #Biopharma

Today, we announced NEW data from the landmark NeoADAURA global cancer trial showing the superiority of ultrasensitive, tumor-informed minimal residual disease (MRD) testing using NeXT Personal®. The new data from an AstraZeneca phase 3 clinical trial in lung cancer demonstrate that 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. Key findings, which will be presented at World Conference on Lung Cancer #WCLC25 (abstract OA02.02) on September 7th, about NeXT Personal from the new NeoADAURA analysis include: • More sensitive: NeXT Personal demonstrated significantly higher baseline sensitivity for ctDNA detection compared to another gene-mutation based test, providing a more accurate assessment of disease burden. • Prognostic: Baseline MRD status, as determined by NeXT Personal, was a strong prognosticator of clinical outcomes across all treatment arms. • Associates with pathological response: Pre-surgical MRD negativity and clearance on the NeXT Personal test were shown to be associated with major pathological response (MPR). • Useful for monitoring treatment: Osimertinib-containing regimens improved pre-surgical MRD clearance vs pbo+CT, showing the utility of ctDNA for monitoring neoadjuvant therapy response. This collaboration builds on previous work with AstraZeneca showing the importance of highly sensitive ctDNA analysis for tracking treatment response and predicting cancer recurrence. This includes a recent publication of Phase 3 CALLA cervical cancer study results showing that NeXT Personal detected traces of cancer DNA in patients with locally advanced cervical cancer up to ~16 months ahead of standard of care imaging. Additionally, the NeoADAURA data presentation follows our recent submission for Medicare coverage for our NeXT Personal liquid biopsy test for use in patients with lung cancer. Discover more from the press release: https://bit.ly/4lUOjrv #PrecisionMedicine #PrecisionOncology #LungCancer #NSCLC #MRD #ctDNA #MedicareCoverage #NeoADAURA

We’re excited to be in Barcelona next month at the IASLC 2025 World Conference on Lung Cancer! Meet our team at Booth # 424 and learn about our ultrasensitive minimal residual disease (MRD) detection platform, NeXT Personal®. NeXT Personal has been utilized in the groundbreaking Lung TRACERx study, led by Professor Charles Swanton, highlighting the value of ultrasensitive ctDNA detection for improved risk stratification in early-stage non-small cell lung cancer (#NSCLC). We look forward to seeing you there! #PrecisionOncology #MRD #ctDNA #WCLC25 #LungCancer #ClinicalTrials #Biopharma

Take a look at the following interview from OncLive with Dr. Jyoti Mayadev (UC San Diego Moores Cancer Center), in which she discusses background and interim results from the CALLA phase 3 cervical cancer study. In this study, “ctDNA using the [NeXT Personal®] ultrasensitive assay was both predictive and prognostic for locally advanced cervical cancer in patients who had positive ctDNA [levels] after their treatment cycle of chemoradiation and durvalumab or placebo,” said Dr. Mayadev at #ASCO25.   Key findings from the study, include: • 99% sensitivity of NeXT Personal ctDNA in detecting disease in baseline, pre-treatment samples. • Risks of progression and death were reduced by at least 95% in both treatment arms for patients who cleared ctDNA by month 3 post-chemoradiotherapy (CRT). • Continued detection of ctDNA following CRT was independently prognostic of poor outcomes. • Detection of ctDNA after CRT was associated with high subsequent risk of disease progression, and preceded disease progression on imaging by a median of ~5 months and up to ~16 months. This analysis supports the potential utility of ultrasensitive NeXT Personal ctDNA testing to help guide treatment decisions in locally advanced cervical cancer (LACC) in the future. Read the article to learn more from Dr. Mayadev: https://bit.ly/47nXWen. #PrecisionOncology #CervicalCancer #ctDNA

“Patients who achieved a molecular complete response, which we defined as clearance of ctDNA, did extremely well. We’re seeing 100% overall survival at year one compared to patients who did not achieve molecular complete response [who] had 52% overall survival at year one.” Listen in as Olga Alexeeva, Director at Personalis, presents NEW ASCO 2025 data on ctDNA-based immunotherapy monitoring in advanced malignancies, exploring the predictive value of circulating tumor DNA kinetics for treatment response and clinical outcomes. In collaboration with UC San Diego Moores Cancer Center (Daisuke Nishizaki), we present this interim, retrospective analysis of 39 patients with advanced cancers. Key findings during immunotherapy treatment monitoring, include: • Patients with molecular response (mR) defined as 50% or greater decrease in ctDNA during treatment from first timepoint to ~23 days later exhibited improved 1-year progression-free survival (PFS) rate of 90% vs 15% in patients without mR. • Patients with mPD (molecular progression defined as 30% or greater increase in ctDNA) preceded standard-of-care imaging detection of progression by a median of 152 days. • mPD was associated with inferior PFS.  • 1y PFS rate for patients without mPD vs. with mPD: 83% vs. 19%. • 33% of all detections were in the ultrasensitive range below 100 parts per million (PPM). #PrecisionOncology #ImmunoTherapy #AdvancedCancer #ImmunoTherapyMonitoring #TreatmentMonitoring #ctDNA #OncologyDiagnostics Reference: Nishizaki, Daisuke, et al. (2025, June). Ultrasensitive ctDNA monitoring reveals early predictors of immunotherapy success in advanced cancer. American Society of Clinical Oncology (ASCO) Annual Meeting. Chicago, IL, United States.

ICYMI: Last week we announced the expansion and extension of our strategic collaboration with Tempus AI, adding a new indication, colorectal cancer (CRC), to the existing, exclusive commercialization agreement. Personalis and Tempus will now work to bring to market the NeXT Personal® ultrasensitive, tumor-informed minimal residual disease (MRD) test to detect cancer recurrence in four areas: breast, lung and colorectal cancers, and solid tumor immunotherapy monitoring. We have amended our agreement with Tempus to further accelerate the adoption of NeXT Personal. The updated terms will include: • Expand the collaboration by adding CRC as the fourth indication for which Tempus will serve as our exclusive commercial partner • Extend the term of the initial agreement to November 2029 • Lengthen the period of Tempus’ exclusivity for all four indications through 2028 Learn more from the press release: https://bit.ly/4nXbK5z. #PrecisionOncology #UltraSensitivityMatters #ctDNA #MRD #ColorectalCancer #BreastCancer #LungCancer #Immunotherapy