Business Wire

CA-PERSONALIS,-INC.

16.12.2021 14:47:11 CET | Business Wire | Press release

Share
Personalis Launches NeXT Personal™, A Tumor-Informed Liquid Biopsy Assay for MRD and Recurrence Detection With Part-Per-Million Sensitivity

Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, today 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.

NeXT Personal leverages whole genome sequencing of a patient’s tumor to identify up to 1,800 specially-selected somatic variants that are subsequently used to create a personalized liquid biopsy panel for each patient. The targeted panel is then used to sequence millions of unique DNA molecules from a patient’s blood sample. Aggregation of signal across these sequences using proprietary algorithms enables part-per-million sensitivity. Personalis’ innovative methods are covered by its broad range of early and subsequent intellectual property filings.

Going beyond other tumor-informed MRD assays, NeXT Personal also simultaneously detects and quantifies clinically relevant mutations in circulating tumor DNA (ctDNA) that may be used in the future to help guide therapy, when cancer is detected. These include known targetable cancer mutations, drug resistance mutations, and new variants which can emerge and change over time, especially under therapeutic pressure.

“With this launch, Personalis is extending what an MRD product can deliver,” said John West, Personalis’ Chief Executive Officer. “With its dramatic increase in sensitivity, we expect to address a range of tumors which were out of reach with earlier technologies. With its broader information content, we also go beyond detection of a tumor, to provide the additional characterization needed to understand and eventually help manage disease.”

“NeXT Personal addresses the need for higher sensitivity assays, opening the door for earlier detection and more sensitive monitoring of patient response to therapy across a broader range of cancers and stages. Today’s release is targeted towards biopharma partners and clinical collaborators. In 2022, we plan to release NeXT Personal as a clinical test, which we expect will yield opportunities for earlier intervention and treatment for cancer patients,” said Dr. Richard Chen, Personalis’ Chief Medical Officer and SVP of R&D.

About Personalis

Personalis, Inc. is a leader in advanced cancer genomics for enabling the next generation of precision cancer therapies and diagnostics. The Personalis NeXT Platform ® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers and clinicians with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. In population sequencing, Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to Veterans Affairs' Million Veteran Program. To enable cancer and population sequencing, Personalis' Clinical Laboratory was built with a focus on clinical accuracy, quality, big data, scale and efficiency. The laboratory is GxP-aligned as well as Clinical Laboratory Improvement Amendments of 1988-certified and College of American Pathologists-accredited. For more information, visit www.personalis.com and follow Personalis on LinkedIn and Twitter .

Forward-Looking Statements

All statements in this press release that are not historical are “forward-looking statements” within the meaning of U.S. securities laws, including statements relating to attributes or advantages of NeXT Personal or the Personalis NeXT Platform, Personalis’ business opportunities, leadership, plans or expectations, the coverage or breadth of the company’s intellectual property, or other future events. Such forward-looking statements involve risks and uncertainties, including those related to the COVID-19 pandemic, that could cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements. Factors that could materially affect actual results can be found in Personalis’ filings with the U.S. Securities and Exchange Commission, including Personalis’ most recent reports on Forms 8-K, 10-K and 10-Q, and include those listed under the caption “Risk Factors.” Personalis disclaims any obligation to update such forward-looking statements.

Link:

ClickThru

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Andersen Consulting tilføjer House of Code for at styrke teknologi- og dataløsninger26.6.2026 20:01:00 CEST | Pressemeddelelse

Andersen Consulting forstærker sine kompetencer inden for teknologisk transformation gennem en samarbejdsaftale med House of Code, en global virksomhed med hovedkvarter i USA, der specialiserer sig i datadrevne platforme, automatisering og agentbaserede ai-løsninger. House of Code blev stiftet i 2001 og udvikler softwareløsninger samt yder rådgivning til energihandels- og finanssektoren med kunder, der spænder over hedgefonde, kapitalfonde og forsyningsvirksomheder. Virksomheden besidder dyb ekspertise inden for energihandel og risikostyring og hjælper organisationer med systemimplementering, forretningstransformation, dataautomatisering og ai-underbygget modernisering af arbejdsgange. Deres proprietære platform, Enterprise Platform for Integrated Compliance (EPIC), skaber en mere effektiv datastyring, automatiserer rapporteringsprocesser, forbedrer den driftsmæssige gennemsigtighed på tværs af virksomhedssystemer og skaber et fundament for opbygning af intelligente, agentbaserede arbe

Capco Recognized by OpenAI for Innovation and Responsible AI Leadership26.6.2026 20:00:00 CEST | Press release

Receives AI Governance & Risk Excellence Award at OpenAI Partner SummitCapco’s UK AI Lab wins OpenAI Codex Hackathon Global management and technology consultancy Capco, a Wipro company,has been recognized by OpenAI for both AI innovation and responsible AI leadership. Capco received the AI Governance & Risk Excellence Award at the recent OpenAI Partner Summit 2026 in San Francisco, highlighting Capco’s ability to deliver enterprise-grade AI outcomes in highly regulated environments. The award recognizes Capco’s expert advantage when helping financial services and energy organizations to scale AI with confidence, balancing innovation with strong governance to reduce risk, strengthen compliance and improve customer outcomes. This award follows Capco winning the OpenAI Codex Hackathon, where its UK AI Lab competed against more than 30 teams and over 100 participants from across the OpenAI partner ecosystem. Capco's winning entry Sentra – a consulting-led, AI-powered retail banking solutio

Incyte Announces Positive CHMP Opinion for Opzelura® (ruxolitinib) Cream for the Treatment of Adults with Moderate Atopic Dermatitis26.6.2026 13:30:00 CEST | Press release

If approved, Opzelura® (ruxolitinib) cream will be the first steroid-free, topical JAK treatment option in the European Union (EU) for adults with moderate atopic dermatitis (AD) for whom standard topical therapies have failedAD, the most common type of eczema which affects 230 million people globally,1 is a chronic, recurring, inflammatory and highly pruritic (itchy) skin condition that can have a significant impact on daily life2Phase 3 TRuE‑AD4 data supporting the positive CHMP opinion demonstrated that ruxolitinib cream met both co‑primary endpoints at Week 8, maintained disease control with as-needed treatment through Week 24 and was well tolerated3,4,5 Incyte (Nasdaq: INCY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Opzelura® (ruxolitinib) cream for the treatment of moderate atopic dermatitis (AD) in adult patients for whom topical corticosteroids

Datroway® Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with Metastatic Triple Negative Breast Cancer Who Are Not Candidates for Immunotherapy26.6.2026 13:00:00 CEST | Press release

Recommendation based on TROPION-Breast02 phase 3 trial where Daiichi Sankyo and AstraZeneca’s Datroway showed a statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival and progression-free survival If approved, Datroway has potential to be the first TROP2 directed antibody drug conjugate for patients in EU with a demonstrated overall survival benefit as first-line treatment Datroway® (datopotamab deruxtecan) has been recommended for approval in the European Union (EU) as monotherapy for the first-line treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. Datroway is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use

DAYBU®(trofinetide) Recommended for Approval in the European Union by CHMP26.6.2026 12:49:00 CEST | Press release

-- European Commission decision expected in the coming months-- If approved, DAYBU®would become the first treatment for neurobehavioral symptoms of Rett syndrome in the European Union Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion following a re-examination procedure, recommending the granting of a marketing authorization for DAYBU® (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older. If granted marketing authorization by the European Commission, DAYBU® would be the first therapy approved for this indication in the European Union (EU). “The CHMP’s positive opinion for DAYBU® is an important milestone in our mission to bring this innovative therapy to the EU, where there are no therapies specifically approved for the neurobehavioral symptoms of this devastating

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye