Personalis’ NeXT Personal® liquid biopsy assay will be deployed in a collaboration for TRACERx to assess approaches for earlier lung cancer recurrence post-surgery and for relapse

Personalis, Inc. (Nasdaq: PSNL), Cancer Research UK’s Cancer Research Horizons, University College London (UCL), and the Francis Crick Institute today 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.

Previously reported findings from the TRACERx study have transformed our understanding of the evolution of the most common type of lung cancer, non-small cell lung cancer (NSCLC), and the TRACERx research team is taking practical steps to make precision medicine for lung cancer patients a reality. The study will utilize Personalis’ NeXT Personal assay, which has demonstrated high sensitivity for detecting a key marker – circulating tumor DNA (ctDNA) – from a patient’s blood sample, with the goal of enabling earlier detection of residual or recurrent cancer.

The current standard of care for NSCLC relapse detection is primarily focused on imaging modalities such as the CT scan, which are known to be limited in their sensitivity. The collaboration is focused on addressing this challenge through advanced ctDNA analysis. As part of TRACERx, the teams will use NeXT Personal to identify and track minimal residual disease (MRD) in patients post-surgery, potentially before relapse is detected through standard of care technologies.

“Thanks to the TRACERx study, we’ve already seen the importance of ctDNA in predicting cancer recurrence in an initial cohort of patients,” said Professor Charles Swanton, MD, PhD, University College London (UCL) and the Francis Crick Institute, and Cancer Research UK's chief clinician and lead researcher of TRACERx. “Personalis’ highly sensitive NeXT Personal assay will allow us to achieve a rich understanding of the complex tumour ecosystem, including by tracking clinically-relevant ctDNA variants at recurrence, and ultimately allowing us to make more informed decisions about patient care.”

"The TRACERx study is greatly advancing our understanding of lung cancer and cancer biology more broadly. Our high sensitivity NeXT Personal MRD assay is uniquely poised to support the study by providing insights about how tumor biology changes over time and by enabling earlier detection of MRD and cancer recurrence. We believe this collaboration will ultimately contribute to an advanced standard of care for cancer patients," said Richard Chen, MS, MD, Chief Medical Officer and Executive Vice President of R&D at Personalis.

About NeXT Personal

NeXT Personal is a next-generation, tumor-informed liquid biopsy assay designed to detect and quantify MRD and recurrence in patients previously diagnosed with cancer. The assay is designed to deliver industry-leading MRD sensitivity down to the 1 part-per-million range, an approximately 10- to 100-fold improvement over other available technologies. It 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. This may enable earlier detection across a broader variety of cancers and stages, including typically challenging early-stage, low mutational burden, and low-shedding cancers. NeXT Personal is also designed to simultaneously detect and quantify clinically relevant mutations in 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 that can emerge and change over time, especially under therapeutic pressure.

About Personalis

At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care from biopsy through the life of the patient. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest timepoints, enable selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California. To learn more, visit www.personalis.com and connect with us on LinkedIn and Twitter.

About TRACERx Study

TRACERx (Tracking Cancer Evolution through therapy (Rx)) lung study is the single biggest investment in lung cancer research by Cancer Research UK. Taking place over ten years, we believe the translational research programme is the first study to look at the evolution of cancer in real time and immense detail. Researchers follow patients with lung cancer all the way from diagnosis through to either disease relapse or cure after surgery, tracking and analysing how their cancer develops. TRACERx is led by UCL (University College London) via the Cancer Research UK Lung Cancer Centre of Excellence and also supported by the National Institute for Health Research, University College London Hospitals Biomedical Research Centre, Francis Crick Institute and the Rosetrees Trust.

About Cancer Research Horizons

• Cancer Research Horizons is the innovation engine of Cancer Research UK – the world’s largest charitable funder of cancer research.
• We bring together world-leading minds, bold ideas and the right partners to bridge the gap between research and taking drugs to market. We focus on the tougher, more profound ideas that can lead to true innovation, translating them into effective treatments and diagnostics for cancer patients.
• To date, we’ve played an instrumental role in forming over 60 spin-out companies.
• We’ve helped bring 11 cancer drugs to market, borne out of Cancer Research UK’s pioneering research. Through these drugs, we have enabled in excess of 6 million courses of treatment for cancer patients across the world.
• With access to Cancer Research UK’s network of 4000 exceptional researchers, and £400+ million of annual research spend, we’re a powerful partner in the fight to conquer cancer.
• Cancer Research Horizons is the second biggest oncology out-licensor globally.
• By uniting our commercial partnerships and therapeutic innovation capabilities, Cancer Research Horizons is uniquely placed to support translational funding, licensing and collaboration, spin out creation, and offer a full spectrum of drug discovery and clinical capabilities.
• Every penny we make goes back into funding the next bold steps, to help bring forward the day when all cancers are conquered.
• For more information and to get in touch with the team, visit www.cancerresearchhorizons.com

About Cancer Research UK

• Cancer Research UK is the world’s leading cancer charity dedicated to saving lives through research, influence and information.
• Cancer Research UK’s pioneering work into the prevention, diagnosis and treatment of cancer has helped save millions of lives.
• Cancer Research UK has been at the heart of the progress that has already seen survival in the UK double in the last 40 years.
• Today, 2 in 4 people survive their cancer for at least 10 years. Cancer Research UK wants to accelerate progress and see 3 in 4 people surviving their cancer by 2034.
• Cancer Research UK supports research into the prevention and treatment of cancer through the work of over 4,000 scientists, doctors and nurses.
• Together with its partners and supporters, Cancer Research UK is working towards a world where people can live longer, better lives, free from the fear of cancer.

Cancer research UK's work or to find out how to support the charity, please call 0300 123 1022 or visit www.cancerresearchuk.org. Follow us on Twitter and Facebook.

About UCL – London’s Global University

UCL is a diverse global community of world-class academics, students, industry links, external partners, and alumni. Our powerful collective of individuals and institutions work together to explore new possibilities. Since 1826, we have championed independent thought by attracting and nurturing the world's best minds. Our community of more than 43,800 students from 150 countries and over 14,300 staff pursues academic excellence, breaks boundaries and makes a positive impact on real world problems. We are consistently ranked among the top 10 universities in the world and are one of only a handful of institutions rated as having the strongest academic reputation and the broadest research impact. We have a progressive and integrated approach to our teaching and research – championing innovation, creativity and cross-disciplinary working. We teach our students how to think, not what to think, and see them as partners, collaborators and contributors. For almost 200 years, we are proud to have opened higher education to students from a wide range of backgrounds and to change the way we create and share knowledge. We were the first in England to welcome women to university education and that courageous attitude and disruptive spirit is still alive today. We are UCL. www.ucl.ac.uk | Follow @uclnews on Twitter | Read news at www.ucl.ac.uk/news/ | Listen to UCL podcasts on SoundCloud | Find out what’s on at UCL Minds

About The Francis Crick Institute

The Francis Crick Institute is a biomedical discovery institute dedicated to understanding the fundamental biology underlying health and disease. Its work is helping to understand why disease develops and to translate discoveries into new ways to prevent, diagnose and treat illnesses such as cancer, heart disease, stroke, infections, and neurodegenerative diseases. An independent organisation, its founding partners are the Medical Research Council (MRC), Cancer Research UK, Wellcome, UCL (University College London), Imperial College London and King’s College London. The Crick was formed in 2015, and in 2016 it moved into a brand-new state-of-the-art building in central London which brings together 1500 scientists and support staff working collaboratively across disciplines, making it the biggest biomedical research facility under a single roof in Europe.

Personalis 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 NeXT Platform, expected benefits of the company’s collaboration with UCL and the Francis Crick Institute, expected performance or adoption of the NeXT Personal assay, Personalis’ business opportunities, leadership, plans or expectations, or other future events. Such forward-looking statements involve risks and uncertainties 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.

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