Personalis

What Personalis does

Personalis, Inc. (NASDAQ: PSNL) is a public precision oncology company founded in 2011 and headquartered in Fremont, California, that develops genome-scale diagnostic services and contract research offerings built around its NeXT Personal ultrasensitive molecular residual disease (MRD) testing platform. The core technology uses whole-genome sequencing to detect circulating tumor DNA (ctDNA) in blood plasma at a sensitivity of approximately 1 part per million while tracking up to approximately 1,800 patient-specific tumor mutations per patient, enabling recurrence detection a median of 5-9 months ahead of standard imaging and longitudinal monitoring of therapy resistance mutations such as ESR1 through its Real-Time Variant Tracker module. Supporting the MRD franchise is a broader NeXT Level solid tumor profiling stack (NeoantigenID, InfiltrateID, ImmunogenomicsID, RepertoireID) and the ImmunoID NeXT biopharma biomarker discovery platform, all processed through the company's on-site CAP-accredited clinical genomics laboratory.

The company monetizes through two primary streams: clinical diagnostic testing reimbursed by Medicare/MolDX for covered indications (breast cancer recurrence surveillance for Stage II-III patients, Stage I-III non-small cell lung cancer surveillance, immunotherapy monitoring for late-stage solid tumors, and breast cancer neoadjuvant therapy monitoring), and contract research and biopharma testing services including the Veterans Affairs Million Veteran Program and pharmaceutical collaborations such as the AstraZeneca Phase 3 LAURA trial. Customer segments span medical and surgical oncologists at comprehensive cancer centers, biopharmaceutical companies running oncology clinical trials, and Medicare-covered patients; commercial reach is extended through a strategic Tempus AI reference laboratory agreement that targets approximately 150,000 colorectal cancer patients annually. GTM combines direct enterprise field sales to oncologists and cancer centers with channel partnerships (Tempus AI), event-driven clinical evidence dissemination at ASCO, AACR, ESMO, and SABCS conferences, and peer-reviewed publications that anchor the reimbursement case for each new Medicare indication.

Name

Personalis

Legal name

Personalis, Inc.

Website

https://personalis.com

Company type

Public

Founded year

2011

Operating status

Operating

Headcount range

251–500 employees

Ownership category

akta.pro rank

Product category

Cancer Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical Laboratories (621511), Medical and Diagnostic Laboratories (62151), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Liquid Biopsy & Minimal Residual Disease (MRD) Precision Testing (HLAAANAG)

akta.pro secondary industries

Immuno-Oncology & Immune Monitoring Biomarkers (TMB, MSI, MRD, immune profiling) (HLAAAMAK), Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE), Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC), Multiplex & High-Throughput Diagnostics Platforms (microarrays, digital PCR, lab automation-enabled assays) (HLAAALAL)

Keywords

• Cancer diagnostics services
• Minimal residual disease testing
• Circulating tumor DNA assays
• Precision oncology genomics
• Liquid biopsy diagnostics

Headquarters

HQ city

Fremont

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Clinical Diagnostic Testing: Clinical test revenue from NeXT Personal MRD tests performed on patient samples. Revenue grew 365% to $1.4 million following Medicare coverage approvals. Reimbursed through Medicare for covered indications including breast cancer and lung cancer surveillance.
2. Pharmaceutical Testing Services: Contract testing services for pharmaceutical companies conducting clinical trials. Revenue declining due to wind-down of enterprise relationships and planned reduction in non-core revenue.
3. VA MVP Program: Population sequencing services for the Veterans Affairs Million Veteran Program. Revenue reduced in recent periods as expected wind-down continues.
4. Biopharma Partnerships: Collaborative research and testing services with biopharma companies including AstraZeneca for clinical trial support and companion diagnostic development.

Pricing tiers

Go-to-market motion3 records

Distribution channels3 records

Marketing channels7 records

Core offering

Personalis fundamentally sells clinical diagnostic testing services and products centered on the NeXT Personal ultrasensitive minimal residual disease (MRD) test, which uses whole-genome sequencing to detect circulating tumor DNA down to ~1 part per million for cancer recurrence detection. The company also offers the NeXT Dx tissue and liquid biopsy assay for solid tumor profiling, the ImmunoID NeXT immunogenomics biomarker discovery platform for biopharma, and CE-IVD marked EDTA and cfDNA blood collection kits. Tests are processed at Personalis' on-site CAP-accredited clinical genomics laboratory in Fremont, California.

Product overview

Personalis offers a platform-plus-modules architecture centered on its NeXT Personal ultrasensitive MRD testing platform for cancer recurrence detection. The core NeXT Personal Dx product uses whole-genome sequencing to detect circulating tumor DNA with sensitivity down to 1 part per million. Supporting the MRD platform are analytics sub-products including GenTraceID (MRD quantification) and VariNTrack (variant tracking), plus the Real-Time Variant Tracker feature for therapy resistance monitoring. The broader portfolio includes NeXT Dx (tissue/liquid biopsy assay), the ImmunoID NeXT immunogenomics platform (encompassing InfiltrateID, ImmunogenomicsID, RepertoireID, and NeoantigenID sub-modules), and CE-IVD marked blood collection kits. The company also provides a CAP-accredited clinical genomics laboratory for test processing.

Differentiator

Problem solved

Functional benefit

Brands

• NeXT Personal Dx: FDA-cleared ultrasensitive MRD test for cancer recurrence detection in blood
• NeXT Personal
• ImmunoID NeXT
• ACE Technology

Products and services

• NeXT Personal Dx An ultrasensitive circulating tumor DNA (ctDNA) test for detecting molecular residual disease (MRD) and cancer recurrence. Uses whole-genome sequencing to track up to ~1,800 patient-specific mutations with sensitivity down to 1 part per million, enabling earlier detection of residual cancer than standard imaging. Sold to oncologists and cancer centers and reimbursed through Medicare for breast cancer, lung cancer, and immunotherapy monitoring indications.
• NeXT Dx A tissue and liquid biopsy assay for solid tumor profiling that provides comprehensive genomic profiling for precision oncology applications. Used by clinicians and biopharma partners for solid tumor characterization.
• ImmunoID NeXT A universal cancer immunogenomics platform providing biomarker assay discovery for immuno-oncology applications. Combines multiple biomarker capabilities including immune cell profiling, tumor microenvironment analysis, and immune repertoire analysis. Sold to biopharma customers for biomarker discovery and immunotherapy research.
• EDTA and cfDNA Blood Collection Kits CE-IVD marked (Class A) blood collection kits for preserving blood sample integrity during collection, transport, and storage for genomic analyses. Designed for use with the NeXT Personal MRD testing platform and distributed to clinical trial sites across the EU and Great Britain.

Quantifiable outcome

• 100% sensitivity for colorectal cancer relapse detection at ASCO 2026
• +5 more outcomes

Named customers7 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability3 records

Feature5 records

Partnerships

Eight partnerships are on record, tiered core and minor.

• Tempus AIcoreChannel Partner/ Reseller/ Distributor · 9 July 2025Strategic commercialization and reference laboratory agreement with Tempus AI to market NeXT Personal across breast cancer, lung cancer, immuno-oncology monitoring, and colorectal cancer indications. Expanded from initial collaboration to target approximately 150,000 colorectal cancer patients annually.
• TRACERx ConsortiumcoreStrategic or Co-development PartnerLandmark lung cancer research consortium providing clinical validation data for Medicare coverage. TRACERx study published in Cell demonstrated test's ability to identify residual disease with high accuracy in early-stage non-small cell lung cancer. Podium presentation at ASCO 2026 highlighted single-digit parts-per-million sensitivity.
• AstraZenecacoreStrategic or Co-development PartnerCollaboration on Phase 3 LAURA clinical trial demonstrating NeXT Personal MRD test utility in monitoring osimertinib treatment response in unresectable Stage III EGFR-mutated NSCLC. Data presented at ESMO 2025 showing detection of disease progression a median of 5 months ahead of standard imaging.
• Veterans Affairs (VA MVP Program)minorOthersPopulation sequencing contract for the VA Million Veteran Program. New task order of $13.5 million increased total VA MVP contracts to approximately $225 million. Revenue declining as expected wind-down continues.
• University College LondoncoreStrategic or Co-development PartnerNEOPRISM-CRC trial collaboration showing 100% sensitivity for disease detection in high-risk colorectal cancer patients. Super molecular responders who cleared ctDNA by second treatment cycle achieved 100% pathological complete response.
• PREDICT-DNA Study CollaboratorscoreStrategic or Co-development Partner227 patients across 24 US cancer centers in PREDICT-DNA study published in Journal of Clinical Oncology demonstrating ctDNA monitoring superiority for neoadjuvant therapy response in breast cancer. Supported Medicare coverage for breast cancer neoadjuvant monitoring.
• Vall d'Hebron Institute of OncologyminorStrategic or Co-development PartnerClinical evidence provider supporting Medicare coverage for immunotherapy monitoring, demonstrating the test's ultrasensitivity enables ongoing evaluation of treatment response and prediction of clinical outcomes.
• European Union/UK Clinical SitesminorChannel Partner/ Reseller/ DistributorCE Mark approval for EDTA and cfDNA Blood Collection Kits enabling use at clinical trial sites across EU and Great Britain for interventional research under IVDR, expanding market presence in Europe.

Scale indicators12 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Natera: Direct competitor offering Signatera, a tumor-informed MRD test using a targeted panel approach for cancer recurrence monitoring across multiple solid tumor indications with established Medicare coverage and broad oncologist adoption.
• Guardant Health: Direct competitor in liquid biopsy oncology, offering Guardant360 for tumor profiling and Reveal MRD test; competes with Personalis across clinical genomic profiling and recurrence monitoring in solid tumors.
• Foundation Medicine: Roche subsidiary offering FoundationOne CDx tissue and FoundationOne Liquid CDx for comprehensive genomic profiling of solid tumors; directly overlaps with Personalis's NeXT Dx tissue/liquid biopsy assay.
• Tempus AI: Both a strategic channel partner for NeXT Personal and a direct competitor in oncology molecular profiling and liquid biopsy; offers xT, xR, and xF assays that overlap with Personalis's biopharma and clinical product lines.
• Exact Sciences: Oncology diagnostics company with Cologuard and the Oncotype pipeline; expanding into MRD and liquid biopsy for colorectal and other solid tumor recurrence monitoring, directly adjacent to NeXT Personal's indications.
• NeoGenomics: Specialized oncology testing laboratory offering comprehensive tumor profiling, liquid biopsy, and MRD services (RaDaR); serves both clinicians and biopharma with overlapping use cases to Personalis.
• Caris Life Sciences: Oncology diagnostics company offering MI Profile (tissue) and MI Cancer Seek (blood) for comprehensive molecular profiling and emerging MRD applications; competes in the same biopharma and clinical oncology testing market.

Emerging players

• Foresight Diagnostics: Emerging player in liquid biopsy and MRD with ultrasensitive ctDNA detection technology targeting lymphoma and solid tumor indications; emerging competitive threat to NeXT Personal in the broader MRD market.
• Adaptive Biotechnologies: Clonal sequencing (clonoSEQ) for MRD in hematologic malignancies with established Medicare coverage; serves as both a partial overlap in MRD space and an adjacency in immune profiling, similar to Personalis's ImmunoID NeXT.

Others

• Bio-Techne: Life science tools and diagnostics company whose ExoDx and related oncology reagents serve adjacent biomarker and diagnostic markets; relevant for understanding the broader oncology diagnostics ecosystem in which Personalis operates.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/PersonalisInc
• Facebookfacebook.com/351047298250443
• LinkedInlinkedin.com/company/personalis-inc

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles15 records

Funding overview

Funding rounds6 records

Investors7 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Personalis