Annuncio • May 22
Personalis, Inc. Expands Medicare Coverage For NeXT Personal Minimal Residual Disease Test Personalis, Inc. announced that the Centers for Medicare & Medicaid Services’ Molecular Diagnostic Services Program has expanded coverage for the company’s NeXT Personal minimal residual disease test. The new coverage determination is for monitoring treatment response to neoadjuvant therapy in patients diagnosed with Stage II-III Triple-Negative Breast Cancer or HER2-positive breast cancer. This decision marks Personalis’ fourth Medicare coverage milestone for NeXT Personal, expanding the test's clinical use in breast cancer. While previous coverage enabled post-surgical recurrence surveillance, this new milestone extends Medicare coverage into the neoadjuvant setting, allowing clinicians to utilize NeXT Personal's ultrasensitive technology to actively monitor therapy effectiveness before a patient undergoes surgery. The coverage determination is underpinned by clinical evidence from the prospective PREDICT-DNA study, recently published in the Journal of Clinical Oncology. The study followed 227 patients with Triple-Negative Breast Cancer and HER2-positive breast cancer across more than 24 US cancer centers. Data from that study demonstrated that ultrasensitive ctDNA monitoring with NeXT Personal allows accurate tracking of neoadjuvant therapy response and outperforms traditional clinical metrics in predicting long-term patient outcomes. A key finding of the PREDICT-DNA study was the clinical necessity of the ultrasensitive range for accurately tracking patient response to neoadjuvant therapy. Nearly half of all ctDNA detections following neoadjuvant therapy occurred at levels below 100 parts per million—low-level traces of cancer that less sensitive minimal residual disease assays can miss. The clinical data published in Journal of Clinical Oncology clearly show that neoadjuvant monitoring benefits from a highly quantitative, ultrasensitive test to capture treatment response dynamics. NeXT Personal’s unique ability to track up to approximately 1,800 patient-specific variants provides the resolution physicians need to confidently track treatment response. With neoadjuvant therapy as the standard of care in a number of breast cancer settings, access to NeXT Personal is expanded for those patients. Annuncio • May 13
Personalis Inc Receives Medicare Coverage for Next Personal for Immunotherapy Monitoring Across Late-Stage Solid Tumors Personalis, Inc. announced that the Centers for Medicare & Medicaid Services’ Molecular Diagnostic Services Program (MolDX) has expanded coverage for the company’s NeXT Personal minimal residual disease (MRD) test to include immunotherapy monitoring for patients with late-stage solid tumors. This coverage determination is underpinned by landmark clinical evidence generated in collaboration with the Vall d’Hebron Institute of Oncology (VHIO). The recently published study demonstrated that NeXT Personal’s ultrasensitivity allows for ongoing evaluation of treatment response and the prediction of clinical outcomes in patients undergoing immunotherapy. By tracking tumor dynamics, the test can identify molecular responders and non-responders ahead of traditional radiologic imaging. Immunotherapy has revolutionized cancer care, with several hundred thousand patients in the US receiving immunotherapy per year, yet treatment response remains variable. Identifying which patients are responding and which are not is critical for optimizing therapeutic pathways, minimizing unnecessary toxicity, and managing the high costs associated with these advanced therapies. NeXT Personal leverages whole-genome sequencing and advanced noise-suppression technology to achieve sensitivity down to 1 part per million (PPM). By tracking up to ~1,800 patient-specific mutations, the assay provides a high-resolution view of a patient’s unique tumor profile. In the immunotherapy setting, where inflammatory responses can often complicate the interpretation of traditional scans (a phenomenon known as pseudoprogression), NeXT Personal provides a clear, molecular signal of true disease burden. The VHIO data shows that immunotherapy monitoring with a highly sensitive, quantitative test like NeXT Personal can help physicians and patients understand treatment response with more precision, including situations where imaging results can be ambiguous. This coverage gives physicians another tool for proactively managing immunotherapy. Annuncio • May 08
Personalis, Inc. has filed a Follow-on Equity Offering in the amount of $150 million. Personalis, Inc. has filed a Follow-on Equity Offering in the amount of $150 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Annuncio • Apr 24
Personalis, Inc. to Report Q1, 2026 Results on May 07, 2026 Personalis, Inc. announced that they will report Q1, 2026 results on May 07, 2026 Annuncio • Apr 23
Personalis Inc Highlights Clinical Impact of Ultrasensitive CtDNA Monitoring and New Therapy Resistance Tracking Personalis, Inc. announced the successful presentation of clinical data at the American Association for Cancer Research Annual Meeting. The data, spanning one oral podium presentation and three posters, underscore the use of the NeXT Personal ultrasensitive ctDNA assay in monitoring treatment response, identifying early recurrence, and tracking the emergence of therapy resistance. A highlight was the oral podium presentation of the NEOPRISM-CRC trial, delivered by Dr. Jiang from the University College London, which utilized NeXT Personal to monitor patients with high-risk stage II-III dMMR/MSI-H colorectal cancer (CRC) receiving neoadjuvant pembrolizumab. In addition to 100% sensitivity for disease at baseline, the study identified three distinct groups of patient response to neoadjuvant treatment: super molecular responders, dynamic molecular responders, and poor molecular responders. Notably, 100% of super molecular responders—those who cleared ctDNA by the second cycle of treatment—also achieved pathological complete response (pCR). Conversely, of poor molecular responders—patients with relatively stable ctDNA levels during neoadjuvant treatment—100% did not achieve pCR. These findings could provide clinicians with a critical window to adjust treatment strategies prior to surgery. Post-surgery, the test achieved a 100% negative predictive value (NPV) and 100% specificity for disease relapse. In a large-scale analysis of nearly 25,000 plasma samples from 10,000 real-world patients, NeXT Personal demonstrated consistent ultrasensitive performance with a median limit of detection of 1.92 PPM. The study also revealed that 39% of all positive MRD detections occurred in the ultrasensitive range below 100 PPM, with 14.6% below 10 PPM—detections that could be missed with less sensitive assays. This study also highlights the robust ultrasensitive performance of the NeXT Personal assay in real-world testing conditions across more than 14 cancer types, stage I-IV disease, and a variety of challenging sample types. Personalis also debuted analytical validation and real-world data for a new opt-in feature of its NeXT Personal MRD test: Real-Time Variant Tracker. This feature allows for the simultaneous monitoring of MRD and the longitudinal tracking of specific resistance-associated mutations, such as ESR1. With a specificity of >99.9%, resistance and other clinical mutations were identified in 38% of MRD-positive patients across the real-world cohort, offering a new tool for tracking treatment resistance as it emerges. The DARWIN 2 study results in metastatic non-small cell lung cancer (NSCLC) demonstrated NeXT Personal’s ability to stratify risk in patients receiving immunotherapy. Patients who achieved a durable molecular complete response (dmCR) remained 100% progression-free at three years, whereas patients who failed to achieve molecular clearance were five times more likely to experience disease progression. Together, these studies illustrate Personalis’ commitment to improving cancer management through ultrasensitive MRD testing throughout the patient journey. Annuncio • Apr 03
Personalis, Inc., Annual General Meeting, May 12, 2026 Personalis, Inc., Annual General Meeting, May 12, 2026. Annuncio • Mar 18
Personalis, Inc. Announces the Promotion of Richard Chen, M.D., M.S., to the Position of President Personalis, Inc. announced the promotion of Richard Chen, M.D., M.S., to the position of President. Dr. Chen will continue to serve as CMO of Personalis in addition to his new role. The appointment comes at a critical inflection point as Personalis transitions from a pioneering R&D powerhouse into a market leader in Minimal Residual Disease (MRD) testing. Under Dr. Chen’s scientific leadership, Personalis developed and accelerated adoption of the NeXT Personal® platform, which set a new industry benchmark for ultrasensitive MRD testing, detecting cancer at levels far below those previously achievable. As President, Dr. Chen will oversee the integration of the company’s R&D capabilities, biopharma services, reimbursement, quality systems and medical affairs to capitalize on the technical excellence of the Personalis platform and accelerate revenue growth. Dr. Chen’s promotion reinforces the company’s commitment to scientific rigor as it scales its commercial footprint. His deep expertise in genomic medicine and machine learning, and his track record of moving innovative R&D projects into high-growth clinical products, make him the ideal leader to help drive this next phase of the company's evolution. Annuncio • Mar 12
Personalis Inc Announces New Publication Advancing Neoadjuvant Treatment Monitoring in Breast Cancer with Next Personal Personalis, Inc. announced the publication of the PREDICT-DNA study in the Journal of Clinical Oncology. The article, "The Pathologic Response Evaluation and Detection In Circulating Tumor-DNA (PREDICT-DNA) study: Ultrasensitive ctDNA Assessment of Breast Cancer Minimal Residual Disease," showed that ultrasensitive molecular residual disease (MRD) testing with NeXT Personal can perform better than current standard approaches in predicting patient outcomes following neoadjuvant therapy (NAT). The prospective study followed 227 patients with Triple-Negative (TNBC) and HER2+ breast cancer across more than 24 US cancer centers. The results demonstrate the ability of NeXT Personal to provide a more precise risk-stratification for patients who have received NAT. A key finding of the study was the necessity of the ultrasensitive range for accurately tracking patient response to neoadjuvant therapy. Of note, 55% of all ctDNA detections following NAT occurred at levels below 100 parts per million, detections that could be missed with less sensitive tests. Key study highlights include: High Prognostic Power: Detectable ctDNA post-NAT was associated with a 4 to 9 times higher likelihood of relapse. Superior to Traditional Metrics: In multivariate analyses, ctDNA status was the most significant independent prognostic signal, performing better than nodal status, tumor grade, and pathologic complete response (pCR) status. In addition, ctDNA detection post-NAT was a stronger predictor of recurrence than pCR status. Identification of Low Risk: Patients who were ctDNA-negative post-NAT showed excellent outcomes, regardless of pCR status. Post-Surgical Relapse Prediction: Patients with detectable ctDNA up to 12 months post-surgery were more than 100 times more likely to experience disease recurrence. The findings reinforce the NeXT Personal test’s ability to detect ctDNA at ultrasensitive levels, providing a window for earlier clinical intervention that other approaches may miss. The NeXT Personal test achieves ultrasensitive detection of small traces of ctDNA from a patient’s blood sample using a personalized approach that tracks up to ~1,800 tumor-specific variants unique to each patient’s tumor. Annuncio • Feb 27
Personalis, Inc. Provides Earnings Guidance for the Full Year of 2026 Personalis, Inc. provided earnings guidance for the full year of 2026. For the year, the company expects total company revenue in the range of $78.0 to $80.0 million; net loss of approximately $105.0 million. Annuncio • Feb 14
Personalis, Inc. to Report Q4, 2025 Results on Feb 26, 2026 Personalis, Inc. announced that they will report Q4, 2025 results on Feb 26, 2026 Annuncio • Feb 10
Personalis, Inc. Receives Medicare Coverage for NeXT Personal®? in Lung Cancer Surveillance Personalis, Inc. announced Medicare coverage for the company's NeXT Personal molecular residual disease (MRD) test for surveillance of patients with Stage I to III non-small cell lung cancer (NSCLC). This coverage determination is grounded in clinical evidence generated through the company's collaboration with the TRACERx (TRAcking Cancer Evolution through therapy (Rx)) consortium. Data from this world-renowned longitudinal study, recently published in Cell, demonstrated NeXT Personal's ability to identify residual disease with high accuracy, validating the test's clinical performance in lung cancer. Lung cancer remains the leading cause of cancer death in the United States, with an estimated ~230,000 new cases diagnosed annually. For patients with Stage I-III NSCLC, the risk of recurrence remains a primary clinical concern. To address this challenge, NeXT Personal is designed to detect trace amounts of circulating tumor DNA (ctDNA) that can indicate the presence of cancer, often before the cancer appears on standard of care imaging scans. Annuncio • Feb 03
Personalis, Inc. Announces New Publication Expanding Evidence for Ultras sensitive ctDNA Monitoring of Cancer Immunotherapy Response Across Solid Tumors Personalis, Inc. announced the publication of a new study in nasensitive molecular residual disease (MRD) assay, NeXT Personal®?, in monitoring immunotherapy response across a broad range of advanced cancers. The study, titled "Ultrasensitive ctDNA monitoring reveals early predictors of immunotherapy response in advanced cancer," was led by oncology researchers at UC San Diego Moores Cancer Center. The findings reinforce the NeXT Personal test's ability to detect circulating tumor DNA (ctDNA) at ultra-compre comprehensive levels, providing a window for earlier clinical intervention that other approaches may miss. The NeXT Personal test achieves ultrasensitive detection of small traces of ctDNA from a patient's blood sample using a personalized approach that tracks up to 1,800 tumor-specific variants unique to each patient's tumor. While immunotherapy has transformed cancer care, only 10-40% of patients achieve durable benefit, making it critical to monitor how patients are responding to therapy. This interim analysis of the ongoing study includes 39 patients with advanced solid tumors--ac across nine different cancer types--treated with immune checkpoint inhibitors alone or in combination with other therapies. Key findings include: Early identification of therapy response: Molecular response--defined by ctDNA dynamics--was detectable early, a median of 23 days after starting immunotherapy. The company aim to drive a new paradigm for cancer management, guiding care throughout the patient journey. The company highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. The company products are designed to detect minimal residual disease (MRD) and recurrence at the earliest timepoints, enable selection of targeted therapies based on ultra-compre comprehensive genomic profiling, and enhance biomarker strategy for drug development. Annuncio • Jan 13
Personalis, Inc. Announces Early Access Launch of Real-Time Variant Tracker Personalis, Inc. announced the early access launch of Real-Time Variant Tracker, a powerful new option added to its ultrasensitive NeXT Personal molecular residual disease (MRD) test designed to detect small traces of circulating tumor DNA (ctDNA) in the blood that represent residual or recurrent cancer. Clinicians using the NeXT Personal MRD test will now be able to opt-in for additional reporting on detected resistance and therapeutically targetable mutations that can inform new opportunities to optimize patient management. This includes ESR1 mutations, which can be an indication to switch therapy for HR+/HER2- breast cancer patients, and hundreds of other clinically relevant mutations for solid tumors. The Real-Time Variant Tracker option for NeXT Personal is available to physicians who participate in the Early Access Program (EAP). The EAP is designed for clinical and academic leaders using NeXT Personal who are looking to integrate this new capability into their clinical practice and research. The ability to track mutations is also available to Personalis' biopharma partners. Annuncio • Dec 13
Personalis, Inc. Publishes Landmark Tracerx Lung Cancer Study in Cell, Demonstrating Ultrasensitive Ctdna Detection Months to Years Ahead of Imaging Personalis, Inc. announced the publication of one of the largest and most comprehensive patient cohorts to date from the landmark TRACERx study, in the journal Cell. The study, titled "Longitudinal ultrasensitive ctDNA monitoring for high-resolution lung cancer risk prediction," demonstrates the clinical importance of ultrasensitive, tumor-informed molecular residual disease (MRD) testing in stage I to III non-small cell lung cancer (NSCLC). The study, led by Professor Charles Swanton at the Francis Crick Institute and University College London (UCL) in collaboration with Personalis, analyzed 431 NSCLC patients tracked for a median of > 5 years using the NeXT Personal® test. It demonstrated that the NeXT Personal test allows for highly sensitive detection of small traces of circulating tumor DNA (ctDNA) in blood samples from lung cancer diagnosis through to surveillance, even in hard-to-detect subtypes. Key Findings: Comprehensive Cancer Detection From Diagnosis Through Surveillance: NeXT Personal demonstrated exceptional sensitivity and specificity for detecting residual and recurrent cancer throughout the patient course at diagnosis (pre-surgery), post-surgical (landmark), during adjuvant, and during long-term surveillance monitoring, with many of the detections (~36-43%) in the ultrasensitive range. Cancer Detection Ahead of Imaging: Cancer was detected a median of ~5 to ~9 months and up to ~57 months ahead of standard of care imaging post-surgery and during surveillance. Ultrasensitive Detection and Risk Stratification: The study demonstrated NeXT Personal detection of ctDNA pre-treatment, post-surgery, and during surveillance was associated with higher risk of relapse and worse overall survival. The study also identified an intermediate risk patient subgroup with ultrasensitive ctDNA detections that can benefit from close clinical follow-up. Therapy Monitoring: Patients who did not clear their ctDNA during adjuvant chemotherapy were > 5 times more likely to relapse than those who cleared their ctDNA. The study utilized Personalis’ NeXT Personal technology, which leverages whole-genome sequencing and proprietary noise suppression to detect ctDNA at levels down to ~1 PPM. The Cell publication highlights that a significant portion of relapsing patients presented with ctDNA levels in the ultrasensitive range, detections which can be missed with less sensitive tests. Annuncio • Nov 29
Personalis, Inc. has filed a Follow-on Equity Offering in the amount of $100 million. Personalis, Inc. has filed a Follow-on Equity Offering in the amount of $100 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Annuncio • Oct 22
Personalis, Inc. to Report Q3, 2025 Results on Nov 04, 2025 Personalis, Inc. announced that they will report Q3, 2025 results on Nov 04, 2025 Annuncio • Oct 17
Personalis, Inc. Announces New Data from A Landmark Lung Cancer Trial Utilizing Ultras sensitive MRD Testing Personalis, Inc. announced new data from an AstraZeneca phase 3 clinical trial in lung cancer (LAURA). The findings demonstrate that Personalis' highly sensitive molecular residual disease (MRD) test, NeXT Personal®?, is a useful tool in assessing the maintenance treatment response post-CRT in patients with unresectable stage III, EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC). The new LAURA analysis will be presented at the ESMO 2025 Conference in Berlin, Germany, demonstrating key findings for NeXT Personal: Treatment monitoring: Osimertinib treatment led to MRD clearance in most patients with post-chemoradiotherapy (post-CRT) MRD, demonstrating the utility of ctDNA for monitoring the maintenance therapy response; Lead time to progression: NeXT Personal detected MRD progression with a median lead time of 5 months ahead of Blinded Independent Central Review (BICR) assessed disease progression. The LAURA trial (NCT03521154) is a global, randomized, placebo-controlled, double-blind, multi-center study of Osimertinib following chemoradiation for patients with unresectable EGFRm NSCLC. This collaboration also 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, and a recent presentation at the IASLC 2025 World Conference on Lung Cancer on the NeoADAURA study demonstrating that NeXT Personal can be a more sensitive and accurate measure of MRD in the neoadjuvant setting. Annuncio • Sep 12
Personalis, Inc. Announces Collaboration with Leading Breast Cancer Team from Yale Cancer Center for A Clinical Trial Personalis, Inc. announced its collaboration with a leading breast cancer team from Yale Cancer Center for a clinical trial titled "A single arm phase II trial of circulating tumor DNA-guided adjuvant therapy with elacestrant in hormone receptor positive HER2 negative breast cancers at risk for late recurrence (CATE"), 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, ultra-sensitive 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 ultrasensitive Personalis 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. Annuncio • Sep 04
Personalis, Inc. Announces New Data from an Astrazeneca Phase 3 Clinical Trial in Lung Cancer (Neoadaura) 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. The findings, which will be presented at the IASLC 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer in Barcelona, Spain on September 7 (abstract OA02.02), demonstrate that NeXT Personal can be a more sensitive and accurate measure of MRD in the neoadjuvant setting. This supports findings in other cancer types that NeXT Personal can help doctors understand how patients are responding to neoadjuvant therapy, with the potential to guide future treatment decisions. Key findings about NeXT Personal from the new NeoADAURA analysis: 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. The NeoADAURA trial (NCT04351555) is a global, randomized, placebo-controlled, double-blind, multi-center study of neoadjuvant osimertinib with or without chemotherapy versus placebo plus chemotherapy for patients with resesectable EGFRm NSCLC. This collaboration also 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. The NeoADAURA data presentation follows Personalis' recent submission for Medicare coverage for its NeXT Personal liquid biopsy test for use in patients with lung cancer. This marks the third indication for which the company is seeking coverage for its ultra-sensitive, whole-genome-based, tumor-informed molecular residual disease (MRD") and recurrence test. Annuncio • Jul 23
Personalis, Inc. to Report Q2, 2025 Results on Aug 05, 2025 Personalis, Inc. announced that they will report Q2, 2025 results at 4:00 PM, US Eastern Standard Time on Aug 05, 2025 Annuncio • Jun 04
Personalis' NeXT Personal®? Predicts Cervical Cancer Recurrence Risk in New CallA Phase 3 Study Analysis Personalis Inc. announced the presentation of new results from the callA phase 3 study showing for the first time its ultrasensitive NeXT Personal circulating tumor DNA (ctDNA) blood test detected cervical cancer progression, up to 16 months ahead of imaging. The results demonstrate the potential of NeXT Personal to enable earlier detection in a cancer with high recurrence rates. The results were presented on June 3, 2025 by Jyoti Mayadev, MD, from the University of California San Diego, at the American Society for Clinical Oncology (ASCO) 2025 Annual Meeting in Chicago in an oral presentation titled "Ultrasensitive detection and tracking of circulating tumor DNA (ct DNA) and association with relapse and survival in locally advanced cervical cancer (LACC): Phase 3 callA trial analyses." The results from this study were also simultaneously published in the journal Annals of Oncology. Samples were analyzed from patients with cervical cancer who had enrolled in the original callA clinical trial. In this new study analysis, NeXT Personal was used to look for small traces of ctDNA in blood samples from a cohort of 186 patients with locally advanced cervical cancer. Dr. Mayadev's team found that overall ctDNA levels after chemoradiotherapy (CRT) treatment were strongly predictive of risk of cervical cancer progression. "Despite standard chemoradiotherapy, up to half of patients with locally advanced cervical cancer relapse, underscoring the urgent need for better prognostic tools. In the callA phase 3 study, ultrasensitive, tumor-informed ctDNA analysis emerged as a powerful predictor of progression and survival--detecting relapse up to 16 months before imaging. These findings highlight ctDNA's potential to guide treatment decisions and personalize care in high-risk cervical cancer," said Dr. Mayadev. Key findings presented: Detection of ctDNA following CRT was independently prognostic of patient outcomes. Company products are designed to detect minimal residual disease (MRD) and recurrent cancer early (including detection earlier than standard of care imaging), monitor or predict a patient's response to therapy or risk of cancer recurrence, accurately predict clinical outcomes for cancer patients, or impact cancer care or management (including for escalation or de-escalation of treatment), or to the clinical adoption or use of, or the ability of Personalis to obtain Medicare coverage or reimbursement for, the NeXT Personal test, or to the sufficiency of the publication and study results described in this press release to support such adoption, use, coverage or reimbursement. Annuncio • Jun 03
New Data Shows NeXT Personal®? Identifies Breast Cancer Patients Receiving Neoadjuvant Therapy That Are At High Risk for Relapse Personalis, Inc. announced the presentation of new clinical results from the PREDICT DNA and SCANDARE studies highlighting the capabilities of its ultrasensitive NeXT Personal circulating tumor DNA (ctDNA) blood test for monitoring and predicting neoadjuvant therapy (NAT) response in triple negative breast cancer (TNBC), one of the most aggressive types of breast cancer. Results from the PREDICT DNA study were presented by Dr.Nat Hunter, MD, University of Washington, at the American Society for Clinical Oncology (ASCO) 2025 Annual Meeting in Chicago in an oral presentation titled "Circulating tumor DNA, pathologic response after neoadjuvant therapy, and survival: First results from TBCRC 040 (the PREDICT DNA trial). The PREDICT DNA study prospectively evaluated ctDNA in early-stage patients with HER2-positive and triple negative breast cancer. The trial was initiated a decade ago and accrued 228 patients across 22 sites in the United States, and was statistically designed and powered for analysis of ctDNA to predict for pathologic complete response (pCR), and whether ctDNA could be a prognostic test to identify patients at high vs. very low risk for recurrence. Annuncio • Apr 29
Personalis' NeXT Personal®? Detects 100% of Colorectal Cancer Relapse Ahead of Imaging in VICTORI Cancer Study Personalis, Inc. 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 study, led by Dr. Jonathan Loree's team at BC Cancer in Vancouver, Canada, utilized NeXT Personal to look for small traces of circulating tumor DNA (ctDNA) in blood samples from a cohort of 71 patients with resectable Stage I-IV 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. 70% of the first ctDNA detections were in the ultrasensitive range, with a median of 24.4PPM and as low as 2.45 PPM. Median patient follow-up at the time of the interim analysis was 15.75 months, with the patients continuing to be followed clinically. Annuncio • Apr 23
Personalis, Inc. to Report Q1, 2025 Results on May 06, 2025 Personalis, Inc. announced that they will report Q1, 2025 results on May 06, 2025 Annuncio • Apr 05
Personalis, Inc., Annual General Meeting, May 16, 2025 Personalis, Inc., Annual General Meeting, May 16, 2025. Annuncio • Feb 28
Personalis, Inc. Provides Earnings Guidance for First Quarter and Full Year 2025 Personalis, Inc. provided earnings guidance for first quarter and full year 2025. For the quarter, the company expects total company revenue to be in the range of $17 million to $18 million.
For the full year, the company expects total company revenue in the range of $80 million to $90 million. Gross margin in the range of 21% to 23%, which is lower than the 32% gross margin for the full year of 2024 as they invest to drive clinical usage ahead of reimbursement. Net loss of approximately $85 million. Annuncio • Feb 14
Personalis, Inc. to Report Q4, 2024 Results on Feb 27, 2025 Personalis, Inc. announced that they will report Q4, 2024 results on Feb 27, 2025 Annuncio • Dec 20
Personalis, Inc. announced that it expects to receive $49.999997 million in funding from Merck Sharp & Dohme LLC Personalis, Inc. entered into an investment agreement with Merck Sharp & Dohme LLC on December 19, 2024. The company will issue 14,044,943 shares, par value $0.0001 per share, at a price per share of $3.56 for gross proceeds of $49,999,997.08. The closing is expected to occur on or about December 19, 2024. Annuncio • Oct 24
Personalis, Inc. to Report Q3, 2024 Results on Nov 06, 2024 Personalis, Inc. announced that they will report Q3, 2024 results on Nov 06, 2024 Annuncio • Aug 16
Personalis, Inc. announced that it expects to receive $17.745 million in funding from Tempus AI, Inc Personalis, Inc. announced that it has entered into an investment agreement with Tempus AI, Inc. pursuant to which the Company issued and sold 3,500,000 shares of the Company’s common stock, par value $0.0001 per share, at a price per share of $5.07. for gross proceeds of $17,745,000 on August 16, 2024. Annuncio • Aug 08
Personalis, Inc. Revises Earnings Guidance for the Year 2024 Personalis, Inc. revised earnings guidance for the year 2024. For the year, the company expects total company revenue in the range of $79.0 to $81.0 million, an increase from $76.0 to $78.0 million. Annuncio • Jul 25
Personalis, Inc. to Report Q2, 2024 Results on Aug 07, 2024 Personalis, Inc. announced that they will report Q2, 2024 results on Aug 07, 2024 Major Estimate Revision • May 15
Consensus estimates of losses per share improve by 11% The consensus outlook for earnings per share (EPS) in fiscal year 2024 has improved. 2024 revenue forecast increased from US$74.0m to US$77.0m. EPS estimate increased from -US$1.58 per share to -US$1.41 per share. Life Sciences industry in the US expected to see average net income growth of 20% next year. Consensus price target of US$4.60 unchanged from last update. Share price fell 8.6% to US$1.43 over the past week. Reported Earnings • May 09
First quarter 2024 earnings released: US$0.26 loss per share (vs US$0.61 loss in 1Q 2023) First quarter 2024 results: US$0.26 loss per share (improved from US$0.61 loss in 1Q 2023). Revenue: US$19.5m (up 3.5% from 1Q 2023). Net loss: US$13.0m (loss narrowed 55% from 1Q 2023). Revenue is forecast to grow 23% p.a. on average during the next 3 years, compared to a 6.5% growth forecast for the Life Sciences industry in the US. Over the last 3 years on average, earnings per share has fallen by 20% per year but the company’s share price has fallen by 56% per year, which means it is performing significantly worse than earnings. Annuncio • Apr 26
Personalis, Inc. to Report Q1, 2024 Results on May 08, 2024 Personalis, Inc. announced that they will report Q1, 2024 results on May 08, 2024 Annuncio • Apr 03
Personalis, Inc., Annual General Meeting, May 17, 2024 Personalis, Inc., Annual General Meeting, May 17, 2024, at 09:00 Pacific Standard Time. Agenda: To elect the Board of Directors’ three nominees for Class II director named in the accompanying proxy statement to hold office until the Company’s 2027 Annual Meeting of Stockholders and until their successors have been duly elected and qualified; To ratify the selection by the Audit Committee of the Board of Directors of BDO USA, P.C. as the Company’s independent registered public accounting firm for the fiscal year ending December 31, 2024; To approve, on a non-binding, advisory basis, the compensation of the Company’s named executive officers; and to discuss other matters. Annuncio • Mar 26
Personalis, Inc. Announces Publication Validating Next Personal Test for Ultra-Sensitive MRD Detection and Cancer Treatment Response Monitoring Personalis, Inc. announced a new publication validating the company’s NeXT Personal test, an ultra-sensitive, tumor-informed circulating tumor DNA (ctDNA) assay. NeXT Personal is designed to help detect minimal residual disease (MRD), monitor therapy response, and identify recurrence with high analytical sensitivity and accuracy, enhancing the decision-making process and ultimately improving patient outcomes in the ongoing battle against cancer. In the analytical validation study published in Oncotarget, scientists from Personalis evaluated NeXT Personal by testing samples from over 120 patients across nine cancer types and paired tumor and normal cell lines. The NeXT Personal technology leverages whole genome sequencing (WGS) and advanced noise suppression with NeXT SENSE technology to identify a unique genetic signature derived from a patient’s tumor based on up to approximately 1,800 variants. Through NeXT Personal, a custom panel is created to detect trace amounts of ctDNA from patient blood samples. The analytical range measurements demonstrated a detection threshold of 1.67 parts per million (PPM) of ctDNA with a LOD95 of 3.45 PPM, highlighting NeXT Personal’s ultra-high analytical sensitivity. Results of the study showed 100% measured analytical specificity, with a confidence interval spanning 99.92 to 100%. Reported Earnings • Mar 02
Full year 2023 earnings: EPS misses analyst expectations Full year 2023 results: US$2.25 loss per share (improved from US$2.48 loss in FY 2022). Revenue: US$73.5m (up 13% from FY 2022). Net loss: US$108.3m (loss narrowed 4.4% from FY 2022). Revenue was in line with analyst estimates. Earnings per share (EPS) missed analyst estimates by 1.7%. Revenue is forecast to grow 25% p.a. on average during the next 3 years, compared to a 6.1% growth forecast for the Life Sciences industry in the US. Over the last 3 years on average, earnings per share has fallen by 26% per year but the company’s share price has fallen by 59% per year, which means it is performing significantly worse than earnings. Annuncio • Mar 01
Personalis, Inc. Provides Earnings Guidance for the First Quarter and Full Year of 2024 Personalis, Inc. provided earnings guidance for the first quarter and full year of 2024. For the quarter, the company expects total revenue to be in the range of $18.0 million to $19.0 million. For the full year, the company expects total revenue to be in the range of $73.0 million to $75.0 million. Net loss to be approximately $80.0 million, down from $108.3 million in 2023 due to realization of savings from the reduction in headcount, partially offset by investments in clinical evidence generation and costs for non-reimbursed clinical tests; the net loss estimate does not include any income or expense from the outstanding warrants issued to Tempus. Annuncio • Feb 15
Personalis, Inc. to Report Q4, 2023 Results on Feb 28, 2024 Personalis, Inc. announced that they will report Q4, 2023 results After-Market on Feb 28, 2024 Annuncio • Jan 16
Personalis Announces Medicare Coverage for Next Dx(R) Comprehensive Genomic Tumor Profiling Assay Personalis, Inc. announced it has received a final Medicare coverage determination for its NeXT Dx ultra-comprehensive tumor genomic profiling assay, providing access for the nation’s 66 million Medicare and Medicare Advantage beneficiaries. Matching patients to their optimal cancer therapy requires a testing platform that can accurately report a broader range of clinically actionable genomic alterations. NeXT Dx analyzes a tumor’s entire exome (DNA) and transcriptome (RNA) to uncover deeper insights into therapy selection, including RNA-based fusions and advanced biomarkers that smaller panels might miss, such as tumor mutational burden (TMB) and microsatellite instability (MSI). In addition, NeXT Dx utilizes paired tumor and non-tumor samples to report more accurate results. Coverage for NeXT DX was extended effective August 29, 2023, under the Palmetto GBA MolDx program foundational Local Coverage Determination (LCD) L38119 (“Next-Generation Sequencing for Solid Tumors”). Personalis estimates that approximately half of new solid tumor cancer cases will be diagnosed in patients covered by Medicare. Annuncio • Jan 05
Personalis, Inc. Provides Unaudited Preliminary Revenue Guidance for the Fourth Quarter and Full Year Ended December 31, 2023 Personalis, Inc. provided unaudited preliminary revenue guidance for the fourth quarter and full year ended December 31, 2023. For the quarter, the company total revenue is estimated to be $19.7 million in the fourth quarter of 2023, an increase of 18% compared with $16.7 million in the fourth quarter of 2022.For the full year, the company total revenue is estimated to be $73.5 million in the full year of 2023, an increase of 13% compared with $65.0 million in the full year of 2022. Annuncio • Dec 22
Personalis, Inc. has filed a Follow-on Equity Offering in the amount of $50 million. Personalis, Inc. has filed a Follow-on Equity Offering in the amount of $50 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Reported Earnings • Nov 10
Third quarter 2023 earnings: Revenues exceed analysts expectations while EPS lags behind Third quarter 2023 results: US$0.60 loss per share (further deteriorated from US$0.58 loss in 3Q 2022). Revenue: US$18.2m (up 23% from 3Q 2022). Net loss: US$29.1m (loss widened 9.8% from 3Q 2022). Revenue exceeded analyst estimates by 7.5%. Earnings per share (EPS) missed analyst estimates by 15%. Revenue is forecast to grow 21% p.a. on average during the next 3 years, compared to a 3.8% growth forecast for the Life Sciences industry in the US. Annuncio • Oct 27
Personalis, Inc. Launches NeXT Personal DX for Early Access Clinical Use in Residual Disease and Recurrence Detection in Cancer Personalis, Inc. announced the launch of the Early Access Program for NeXT Personal Dx, a tumor-informed, whole genome-based liquid biopsy laboratory developed test (LDT) for detection of molecular residual disease (MRD) and recurrence in cancer. Designed to help oncologists detect cancer recurrence earlier and aid in treatment decision-making, NeXT Personal Dx is poised to reshape the clinical use of MRD testing by delivering unmatched sensitivity down to the level of one circulating tumor DNA (ctDNA) molecule in a million. NeXT Personal Dx features: Unpre unprecedented sensitivity and specificity: analytical sensitivity, detecting down to ~1 PPM (parts per million) or 1x10-6 tumor fraction and >99.9% analytical specificity; Whole genome-based tumor-informed assay: Selects up to 1,800 variants to design a highly sensitive and specific personalized tumor signature for each patient; NeXT SENSE technology: Proprietary Signal Enhancement and Noise Suppression Engine that, together with the personalized tumor signature, enables ultra-sensitive detection. The NeXT Personal Dx test is currently available through an Early Access Program to a limited number of clinical customers as the company builds clinical evidence and achieves Medicare reimbursement. The EAP will enable oncologists to access NeXT Personal Dx for clinical use, with a focus on lung cancer, breast cancer, and immunotherapy response monitoring. Personalis also recently announced data from the groundbreaking TRACERx study investigating the use of NeXT Personal in early-stage lung cancer for MRD and recurrence detection. Personalis, along with collaborators from Cancer Research UK's Cancer Research Horizons, University College London (UCL), and the Francis Crick Institute, presented data at the 2023 European Society for Medical Oncology (ESMO) Congress showing the ability of NeXT Personal to detect lung cancer more sensitively and identify cancer recurrence with a median lead time of approximately 6 to 11 months ahead of traditional imaging, and significantly longer than previous TRACERx results. Annuncio • Oct 25
Personalis, Inc. to Report Q3, 2023 Results on Nov 07, 2023 Personalis, Inc. announced that they will report Q3, 2023 results on Nov 07, 2023 Annuncio • Oct 22
Personalis, Inc. Announces the Presentation of Initial Findings from Its Work with the Tracerx Lung Cancer Study Personalis, Inc. announced the presentation of initial findings from its work with the TRACERx lung cancer study, marking a substantial advancement in lung cancer circulating tumor DNA (ctDNA) detection and management. Thealis NeXT Personal cancer assay, created to detect and monitor residual and recurrent disease (MRD), demonstrated significantly improved detection rates for early-stage lung cancer, including lung adenocarcinoma (LUAD), one of the most common and challenging subtypes of non-small cell lung cancer (NSCLC) to identify in blood samples. The findings come from an analysis by Professor Charles Swanton, Dr. James Black, and other members of the TRACERx consortium, renowned for their work on the complexities of cancer genomics. The findings were presented by Dr. Black at the 2023 European Society for Medical Oncology (ESMO) Congress on October 21 in Madrid, Spain, and are the first publicly presented results from Personalis' collaboration with Cancer Research UK's Cancer Research Horizons, University College London (UCL), and the Francis Crick Institute. Lung cancer is the second most common cancer in the U.S., with an estimated 238,000 new cases and approximately 127,000 deaths forecasted for 2023. The current standard of care for relapse detection of NSCLC, the most common type of lung cancer, is primarily focused on imaging modalities such as CT scans, which are known to be limited in sensitivity. This ongoing collaboration is focused on addressing this challenge through advanced ctDNA analysis. For the current analysis, the teams used NeXT Personal to identify and track MRD in over 170 patients from the TRACERx cohort. In this analysis, NeXT Personal showed significantly higher sensitivity in early-stage NSCLC patients compared to two previous publications on the TRACERx cohort; Pre-surgery, the assay demonstrated 100% sensitivity for ctDNA in pre-surgical non-LUAD samples and 81% pre-surgical ctDNA sensitivity for LUAD, one of the most common types of lung cancer but also one of the most challenging to detect in blood. The pre-surgical sensitivity for early-stage LUAD was up to 4X higher than in previous studies on the TRACERx cohorts, depending on stage. This high sensitivity enhanced the assay's ability to detect recurrence and monitor lung cancer effectively. Ability to identify low and high recurrence risk prior to surgery; The study demonstrated that pre-surgical ct DNA levels with NeXT Personal could be used to classify early-stage lung cancer patients into lower- and higher-recurrence risk groups. Furthermore, the analysis showed that the ultra-low levels of ctDNA detection enabled by NeXT Personal were critical to determining patient recurrence risk. For example, LUAD patients who were ctDNA-negative before surgery with NeXT Personal strikingly exhibited a 100% 5-year overall survival rate and 94% relapse-free survival rate in the TRACERx cohort". In comparison, patients who were ctDNA -positive prior to surgery had a high risk of cancer recurrence over 5 years. The NeXT Personal technology leverages whole genome sequencing and advanced noise suppression with NeXT SENSE? technology to identify a unique genetic signature derived from a patient's tumor based on up to 1,800 variants. This unique signature is tracked in the patient's blood over time to find residual or recurrent cancer, achieving an sensitivity of down to 1 PPM. This enhanced sensitivity offers the potential for earlier recurrence risk assessment and intervention, earlier detection, more precise monitoring, and substantial advancement in lung cancer care. "Pat patients often live in fear of undetected cancer leading to a relapse. Company new assay is a transformative leap forward--it's like turning on a spotlight in a previously dark room. It finds what other tests often miss, providing a new level of certainty and peace of mind. This isn't just about technology; it's about giving patients and their families a clearer level of confidence. Annuncio • Oct 20
Personalis, Inc. Appoints Deepshikha Bhandari as SVP, Regulatory, Quality and Clinical Compliance Personalis, Inc. announced the appointment of Deepshikha Bhandari as SVP, Regulatory, Quality and Clinical Compliance. With over two decades of industry marketing and regulatory affairs experience, Ms. Bhandari will help the company navigate the regulatory requirements for the NeXT Personal MRD test. She was most recently VP, Regulatory Affairs at GRAIL, and previously held senior positions at Roche Diagnostics and Abbott Vascular. New Risk • Aug 13
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 5.7% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$77m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (5.7% increase in shares outstanding). Market cap is less than US$100m (US$99.5m market cap). Annuncio • Aug 10
Personalis, Inc. Provides Earnings Guidance for the Third Quarter and Full Year of 2023 Personalis, Inc. provided earnings guidance for the third quarter and full year of 2023. For the quarter, the company expects total revenue to be approximately $17 million.For the full year, the company expects total revenue to be in the range of $70 million to $72 million. Net loss to be approximately $103 million reduced from $113 million in 2022 due to realization of headcount reduction savings, partially offset by investments in clinical evidence generation and non-cash depreciation expense for the new facility. 
