^
Contact us  to learn more about
our Premium Content:  News alerts, weekly reports and conference planners

TEST:
NeXT Personal™

Company:
Personalis
Type:
Laboratory Developed Test
Related tests:
Evidence

News

10d
Analytical validation of NeXT Personal®, an ultra-sensitive personalized circulating tumor DNA assay. (PubMed, Oncotarget)
The assay targets 99.9% specificity, with this validation study measuring 100% specificity and in silico methods giving us a confidence interval of 99.92 to 100%. In summary, this study demonstrates NeXT Personal as an ultra-sensitive, highly quantitative and robust ctDNA assay that can be used to detect residual disease, monitor treatment response, and detect recurrence in patients.
Journal • Circulating tumor DNA
|
NeXT Personal™
23d
Ultra-sensitive ctDNA detection predicts response to immune checkpoint inhibition in advanced melanoma patients (AACR 2024)
Our findings suggest that ctDNA changes arepredictive of ICI response in late stage melanoma. These results highlight the potential for patient-specific ctDNA monitoring to inform patient management and for clincal trial design.
Clinical • Checkpoint inhibition • IO biomarker • Circulating tumor DNA • Metastases
|
NeXT Personal™
23d
Detection of MRD assessment with the Personalis NeXT Personal assay using MATRIX plasma-in-plasma contrived samples (AACR 2024)
This approach addresses all parts of an MRD assay for both the plasma and tumor/normal tissues, utilizing real clinical samples while allowing direct interrogation of sensitivity. The Personalis NeXT Personal assay shows ultra-high sensitivity with reproducible data down to the 1-3 PPM range.
NeXT Personal™
23d
Analytic validation of an ultra-sensitive tumor-informed circulating tumor DNA assay based on whole genome sequencing (AACR 2024)
The assay also demonstrated strong performance across varying cfDNA input amounts from 2 ng to 30 ng. These studies demonstrate that NeXT Personal is an ultra-sensitive, highly specific, quantitative and robust assay, giving it the potential to detect residual disease and recurrence earlier than less sensitive assays.
Circulating tumor DNA • Whole genome sequencing
|
NeXT Personal™
23d
Detection of circulating tumor DNA predicts survival in advanced HCC patients treated with personalized therapeutic DNA cancer vaccine in combination with immune checkpoint blockade (AACR 2024)
NeXT Personal®, an ultra-sensitive tumor-informed ctDNA assay was used to longitudinally track ctDNA in advanced hepatocellular carcinoma (HCC) patients treated with GNOS-PV02 (a personalized therapeutic DNA cancer vaccine) in combination with pembrolizumab.Advanced unresectable or metastatic HCC patients that progressed on, or were intolerant to, first-line TKI therapy were enrolled into the Phase 1b/2a GT-30 study [NCT04251117]. ctDNA clearance was observed in all 3 CR patients with a lead time of 483, 126 and 105 days compared with MRI.This ultra-sensitive ctDNA assay shows significant association between ctDNA change and clinical response and survival, and can be used to accurately predict clinical outcome. The convenience of non-invasive liquid biopsy and rapid availability of data could enable the use of ctDNA to allow real-time monitoring of personalized cancer immunotherapy.
Clinical • Combination therapy • Checkpoint inhibition • Circulating tumor DNA • Checkpoint block • Metastases
|
NeXT Personal™
|
Keytruda (pembrolizumab) • GNOS-PV02
1m
New trial • Circulating tumor DNA
|
NeXT Personal™
4ms
Personalis and Tempus enter into a strategic collaboration to advance cancer testing (Personalis Press Release)
"Personalis, Inc...and Tempus Labs, Inc...announced a strategic collaboration to co-commercialize NeXT Personal® Dx, Personalis’ whole genome-based liquid biopsy laboratory developed test (LDT) for detection of molecular residual disease (MRD) and recurrence in cancer. NeXT Personal Dx is a leap forward in tumor-informed approaches, setting the new standard in performance of MRD tests with unprecedented sensitivity and high specificity. The test was launched by Personalis in October of this year."
Licensing / partnership
|
NeXT Personal™
5ms
Personalis launches NeXT Personal® Dx for early access clinical use in residual disease and recurrence detection in cancer (Personalis Press Release)
"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."
Launch
|
NeXT Personal™
5ms
Analysis from TRACERx study reveals more sensitive and earlier ctDNA detection in lung cancer patients by Personalis' MRD technology (Personalis Press Release)
"Personalis, Inc...announced the presentation of initial findings from its work with the groundbreaking TRACERx lung cancer study, marking a substantial advancement in lung cancer circulating tumor DNA (ctDNA) detection and management. The Personalis 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."
Clinical data
|
NeXT Personal™
5ms
Personalis announces late-breaking NeXT Personal abstract and proffered paper presentation at ESMO 2023 (Personalis Press Release)
"Personalis, Inc...announced that a late-breaking abstract featuring data for the company’s NeXT Personal® whole genome-based, tumor-informed assay for ultra-sensitive ctDNA detection, has been accepted and selected for a proffered paper presentation at the 2023 European Society for Medical Oncology (ESMO) Congress, on October 21 in Madrid, Spain."
Clinical data
|
NeXT Personal™
8ms
An ultra-sensitive and specific ctDNA assay provides novel pre-operative disease stratification in early stage lung cancer (ESMO 2023)
Critically, LUAD patients with ctDNA present at below 80 PPM (the 95% limit of detection for our recently published ctDNA detection approach in TRACERx) experienced reduced OS compared to those in which ctDNA was not detected (p=0.002, HR=12.2). Conclusions Our ultra-sensitive approach demonstrates superior analytic performance and prognostic prediction compared to other assays previously clinically validated in non-small cell lung cancer and provides an advanced stratification tool to guide adjuvant therapy in early-stage ctDNA-positive disease at high risk of relapse.
Late-breaking abstract • Circulating tumor DNA
|
NeXT Personal™
10ms
Personalis Announces Two Abstracts Accepted for Presentation at ASCO 2023 (Businesswire)
"Personalis, Inc. (Nasdaq: PSNL) today announced it will present new clinical data as scientific posters at the American Society of Clinical Oncology (ASCO) Annual Meeting 2023, which convenes from June 2-6, 2023, in Chicago, Ill....At ASCO, Personalis will present data from two retrospective clinical studies that demonstrate a breakthrough in ctDNA detection sensitivity."
Retrospective data
|
NeXT Personal™
|
Keytruda (pembrolizumab)
11ms
Personalis, National Cancer Center Hospital East, and Ono Collaborate to Better Predict Immunotherapy Response for Rectal Cancer (Businesswire)
"Personalis, Inc...and Ono Pharmaceutical Co., Ltd. today announced they have entered into a collaborative agreement to examine the efficacy and safety of nivolumab, an immune checkpoint inhibitor, for resectable rectal cancer with mismatch repair deficiency (dMMR). As part of the collaboration on the VOLTAGE-2 study, an exploratory analysis will be conducted to evaluate specific biomarkers such as minimal residual disease (MRD) status that may have prognostic or predictive value for patient care. Under the agreement, National Cancer Center Hospital East (NCCHE) will recruit patients and conduct the clinical trial, Ono will provide nivolumab, and Personalis will perform MRD and biomarker testing."
Licensing / partnership
|
NeXT Personal™
|
Opdivo (nivolumab)
11ms
Personalis, ABRCC, and Criterium Announce Major Prospective Clinical Trial for Residual and Recurrent Disease Detection in Triple Negative Breast Cancer (Businesswire)
"Personalis, Inc...announced it has partnered with the Academic Breast Cancer Consortium (ABRCC) and Criterium to carry out a prospective clinical trial, B-STRONGER-1 (Breast Cancer-Minimal Residual Disease Detection and Therapy Monitoring in Patients with Early Stage TNBC-Phase I), to evaluate the clinical performance of the NeXT Personal® test for detecting minimal residual disease (MRD) during and after treatment and recurrent cancer in patients with early-stage resectable triple-negative breast cancer (TNBC)."
Licensing / partnership
|
NeXT Personal™
11ms
MATRIX plasma-in-plasma contrived samples assessment and detection of MRD using the Personalis NeXT Personal assay. (ASCO 2023)
The MATRIX plasma-in-plasma approach is a robust option for assessing the sensitivity of MRD assays to low levels of ctDNA. This approach addresses all parts of an MRD assay for both the plasma and tumor/normal tissues, and is the closest thing to real clinical samples while allowing direct interrogation of sensitivity. Additionally, it allows assessment of any genomic or epigenomic biological feature.
NeXT Personal™
11ms
Large healthy donor dataset demonstrates high analytical specificity and repeatability for the NeXT Personal molecular residual disease assay. (ASCO 2023)
The large healthy donor screening study demonstrated that our assay maintains excellent specificity and repeatability while still achieving ultra-sensitive detection. In all cases, the observed error-rates in the panels were very low and did not affect detection specificity. Overall these landmark specificity and repeatability results lend further confidence to the robustness of the analytical performance of NeXT Personal.
Clinical
|
NeXT Personal™
11ms
Tracking MRD and neoantigen targets using a tumor-informed liquid biopsy platform in HCC patients treated with personalized cancer vaccine and pembrolizumab. (ASCO 2023)
We used an ultra-sensitive, tumor-informed ctDNA platform to longitudinally track tumor neoantigen targets and monitor molecular residual disease (MRD) in advanced HCC patients (pts) being treated with a DNA personalized therapeutic cancer vaccine (GNOS-PV02). Highly sensitive tracking of MRD and neo-antigenic variants over the course of therapy was achieved using a single assay. We show that ctDNA can sensitively monitor disease status non-invasively, potentially leading to accurate clinical outcome prediction. Additionally, the ease of sample handling, analysis, and rapid availability of data could enable the use of ctDNA monitoring to allow real-time dynamic personalized cancer immunotherapy.
Clinical • PD(L)-1 Biomarker • IO biomarker • Liquid biopsy • Biopsy
|
NeXT Personal™
|
Keytruda (pembrolizumab) • GNOS-PV02
11ms
Association of ultra-sensitive ctDNA assay to identify actionable variants and response to immune checkpoint inhibitor (ICI) therapy in metastatic melanoma. (ASCO 2023)
We tracked both tumor-informed MRD and tumor-agnostic evolution of ICI related variants over the course of treatment using a single liquid biopsy platform. We achieved ultra-sensitive ctDNA detection down to 2.3 PPM and dynamics in ctDNA signals were predictive of clinical outcome. Furthermore, we demonstrated that ctDNA measurements and VAF dynamics of clinically actionable and resistance variants correlated with response as well as resistance to ICI.
Checkpoint inhibition • IO biomarker • Circulating tumor DNA • Metastases
|
BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • NRAS (Neuroblastoma RAS viral oncogene homolog) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • MAP2K1 (Mitogen-activated protein kinase kinase 1) • KEAP1 (Kelch Like ECH Associated Protein 1) • JAK1 (Janus Kinase 1)
|
NeXT Personal™
11ms
Ultra-sensitive, tumor-informed ctDNA profiling in patients with gastroesophageal cancer and treated with pembrolizumab and longitudinal ctDNA kinetics. (ASCO 2023)
KeyLargo (NCT03342937) was a single arm phase II study of pembrolizumab in combination with oxaliplatin and capecitabine in the first line treatment of patients (pts) with HER2 negative mEGC. ctDNA was present in all pts at baseline; OT PPM reductions correlated with PFS and best overall response. CAV profiling suggested a de novo PIK3CA variant arising during therapy in one patient. These findings suggest that tumor-informed plasma-based ctDNA profiling in mEGC may detect known CAVs arising during therapy, and with subsequent investigations, may inform therapeutic decisions.
Clinical • PD(L)-1 Biomarker • IO biomarker • Circulating tumor DNA
|
HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
|
HER-2 negative • PIK3CA mutation
|
NeXT Personal™
|
Keytruda (pembrolizumab) • capecitabine • oxaliplatin
12ms
Personalis joins top UK cancer research organizations to evaluate earlier cancer recurrence detection through groundbreaking study (Personalis Press Release)
"Personalis, Inc....Cancer Research UK’s Cancer Research Horizons, University College London (UCL), and the Francis Crick Institute...announced a collaboration to deploy NeXT Personal, a personalized liquid biopsy-based research assay, for the TRACERx study, a groundbreaking lung cancer initiative funded by Cancer Research UK."
Licensing / partnership
|
NeXT Personal™
1year
Personalis Announces Four Abstracts Accepted for Presentation at AACR Annual Meeting 2023 (Businesswire)
"The data highlights the power of the company’s highly-discerning technologies that both characterize and monitor cancer, including initial research findings from a collaboration with University Medical Center Hamburg-Eppendorf (UKE) and its new Fleur-Hiege Center for Skin Cancer Research, where Dr. Klaus Pantel, Dr. Christoffer Gebhardt, and team are using NeXT Personal® to track tumor response to immunotherapy (IO) in patients with melanoma, with the aim of gathering evidence to advance the use of ultra-sensitive minimal residual disease (MRD) detection in routine clinical practice for IO therapy monitoring."
Clinical data
|
NeXT Personal™
1year
Analytical performance of an ultra-sensitive, tumor-informed liquid biopsy platform for molecular residual disease detection and clinical guidance (AACR 2023)
The assay is sufficiently sensitive for early stage, low shedding, and low TMB cancers, early time points or samples with limited input. The addition of clinically relevant tumor-agnostic actionable content makes NeXT Personal unique in its ability to detect MRD and to ultimately help guide clinicians.
Clinical • Tumor mutational burden • IO biomarker • Liquid biopsy • Biopsy
|
TMB (Tumor Mutational Burden)
|
TMB-L
|
NeXT Personal™
1year
Ultra-sensitive tumor-informed ctDNA assay predicts survival in advanced melanoma patients treated with immune checkpoint inhibition (AACR 2023)
Advanced melanoma patients exhibit a wide range of ctDNA concentrations at the beginning and during the course of treatment. Ultra-sensitive ctDNA detection down to 2.3 PPM was achieved using the NeXT Personal platform. Most importantly, our pilot study indicates that ctDNA measurements correlated with clinical outcome.
Checkpoint inhibition • Clinical • IO biomarker • Circulating tumor DNA • Metastases
|
BRAF (B-raf proto-oncogene)
|
BRAF V600E • BRAF V600
|
NeXT Personal™
1year
Personalis selected for clinical research after successful evaluation of whole genome-based molecular residual disease assay (Personalis Press Release)
"Personalis...announced it will continue its collaboration with AstraZeneca...to explore ultra-sensitive molecular residual disease (MRD) measurement, including clinically relevant and personalized variant tracking, for clinical research and drug development...As part of the collaboration, Personalis’ NeXT Personal assay for liquid biopsy will aim to provide ultra-sensitive measurement of MRD, on-treatment therapy resistance tracking, and better differentiation between responders and non-responders, as well as investigate the underlying mechanisms driving cancer."
Licensing / partnership • Clinical
|
NeXT Personal™
1year
NeXT Personal™: Launch of LDT in H2 ‘23 (Personalis)
Investor Presentation: Submission of first indication for Medicare coverage in ‘24
Medicare • Launch • Reimbursement
|
NeXT Personal™
over1year
Personalis and UCSF to Study Clinical Utility of ctDNA for Treatment Response in Colorectal Cancer (Personalis Press Release)
"Personalis, Inc...announced a collaboration with UC San Francisco (UCSF) that will deploy a personalized liquid biopsy-based research use only (RUO) assay for a study of patients with colorectal cancer. The research efforts will use Personalis’ NeXT Personal™ assay to evaluate circulating tumor DNA (ctDNA)-based signatures associated with treatment response and adverse events in a cohort of late-stage colorectal cancer patients receiving capecitabine together with pembrolizumab and bevacizumab."
Licensing / partnership
|
NeXT Personal™
|
Keytruda (pembrolizumab) • Avastin (bevacizumab) • capecitabine
over1year
Launch
|
NeXT Personal™
over1year
Personalis forms research collaboration to better predict immunotherapy response for gastroesophageal cancer (Personalis Press Release)
"Personalis, Inc...has joined with Duke University and Olink Proteomics AB to form a research collaboration to study the effects of immunotherapy on advanced gastroesophageal cancer. Specifically, the collaboration will focus on identifying composite biomarkers—those that integrate multiple biological entities into a single readout—to help guide therapeutic decision making...Personalis’ NeXT Personal assay will be used to analyze circulating tumor DNA (ctDNA) collected from patients in order to profile and accurately track molecular residual disease (MRD) over the course of therapy."
Licensing / partnership
|
NeXT Personal™
over1year
Personalis adds new MRD patent covering the combination of tumor-informed and database-derived content to patent infringement complaint against Foresight Diagnostics (Personalis Press Release)
"Personalis, Inc...announced...it has filed an amended complaint against Foresight Diagnostics. The amended complaint asserts a newly-issued patent in Personalis’ growing intellectual property portfolio relating to detection of molecular residual disease (MRD)...Personalis’ patent portfolio protects its groundbreaking work in whole genome sequencing to identify mutations that indicate the continued presence or recurrence of cancer with an unprecedented part-per-million sensitivity, which its recently-launched MRD solution, NeXT Personal, is uniquely designed to achieve."
Corporate lawsuit • Patent
|
NeXT Personal™
over1year
Personalis in partnership with BC Cancer to assess clinical and economic benefits of ctDNA for colorectal and pancreatic cancers (Personalis Press Release)
"Personalis, Inc. has announced a collaboration with BC Cancer to deploy a personalized liquid biopsy-based research use only (RUO) assay for a study of patients with colorectal and pancreatic cancers. The research efforts will deploy Personalis’ NeXT Personal, which has demonstrated high sensitivity for detecting circulating tumor DNA (ctDNA) from a patient’s blood sample, to determine the best time to draw blood for ctDNA sampling for molecular residual disease (MRD) detection. MRD describes a very small number of cancer cells that remain in the body during or after treatment."
Licensing / partnership
|
NeXT Personal™
over1year
Personalis files patent infringement lawsuit against Foresight Diagnostics (Personalis Press Release)
"Personalis, Inc...announced today that it filed a lawsuit against Foresight Diagnostics Inc. for infringement of Personalis’ U.S. Patent Nos. 10,450,611, 11,299,783, and 11,384,394. These patents are part of Personalis’ intellectual property portfolio in the field of whole genome-enabled, tumor-informed molecular residual disease (MRD) testing...NeXT Personal is purpose-built to accurately detect MRD in patient samples with low overall ctDNA, which is particularly important for cancers that have low shedding or low mutational burden, such as breast and prostate cancers, or soon after resection."
Corporate lawsuit • Patent
|
NeXT Personal™
over1year
Personalis announces expansion of its patent portfolio related to tumor-informed detection of molecular residual disease (Personalis Press Release)
"Personalis, Inc...has added another patent family to its molecular residual disease (MRD)-related IP portfolio, with priority to January 2013. US Patent No. 11,384,394 describes the detection of MRD and recurrence by using whole genome sequencing of a patient’s tumor to identify variants for a personalized liquid biopsy assay...As with recently issued US Patent 11,299,783, the ‘394 patent covers many elements of Personalis’ NeXT PersonalTM platform, including that it describes a highly sensitive measurement of tumor burden with simultaneous tracking of up to thousands of tumor variants, both tumor-informed and prespecified, in a single panel design."
Patent
|
NeXT Personal™
over1year
Personalis Satellite Symposium (ITOC 2022)
A clinical case study in a cohort of late-stage melanoma patients demonstrating how the integration of neoantigen burden, HLA LOH, and Antigen Presentation Machinery (APM) mutational data formed a composite biomarker that more accurately predicted response to checkpoint blockade than other markers. In parallel, specimens may be processed using NeXT Personal™, an ultrasensitive tumor-informed liquid biopsy assay, designed to detect molecular residual disease and cancer recurrence at the earliest timepoints, with simultaneous variant tracking for additional insight into disease progression
NeXT Personal™
almost2years
Personalis announces issuance of additional US Patent related to the NeXT Personal™ Platform (Personalis Press Release)
"Personalis, Inc...announced the issuance of a key US Patent related to its industry-leading minimal residual disease (MRD) and recurrence platform, NeXT Personal...The patent, US Patent No. 11,299,783, entitled 'Methods and Systems for Genetic Analysis,' was issued on April 12, 2022. The ‘783 patent claims novel methods for a partially personalized assay, combining both tumor-informed and prespecified (tumor naïve) content. Tumor-informed methods can provide high sensitivity for detection of MRD."
Patent
|
NeXT Personal™
2years
Personalis to Present Data Demonstrating Breadth of NeXT Platform for Oncology at AACR Annual Meeting 2022 (Personalis Press Release)
"Personalis, Inc...announced it is presenting new data in scientific posters at the American Association for Cancer Research (AACR) Annual Meeting 2022, which will be held in-person and online, April 8-13, 2022....The NeXT Liquid Biopsy platform monitors tumor variants and discovers novel mutations in the plasma, through analysis of tumor, normal and plasma samples from the same patient."
Clinical data
|
NeXT Personal™
over2years
Personalis launches NeXT Personal™, a tumor-informed liquid biopsy assay for MRD and recurrence detection with part-per-million sensitivity (Personalis Press Release)
"Personalis...announced the launch of NeXT Personal, a next-generation, tumor-informed liquid biopsy assay designed to detect and quantify molecular residual disease (MRD) and recurrence in patients previously diagnosed with cancer. NeXT Personal delivers industry-leading MRD sensitivity down to the 1 part-per-million range, an approximately 10- to 100-fold improvement over other available technologies. This enables earlier detection across a broader variety of cancers and stages, including typically challenging early stage, low mutational burden, and low-shedding cancers."
Launch
|
NeXT Personal™