Personalis’ NeXT Personal™ liquid biopsy assay will be deployed in study collaboration

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.

Identification and tracking of MRD is an emerging focus in the clinical care of patients with gastrointestinal cancers such as colorectal and pancreatic cancer, which may improve overall clinical management throughout a patient’s journey. Researchers are also hoping to show that ctDNA is useful in identifying cancer progression before the current standard of care tests and use the data to do an economic analysis to assess cost-effectiveness for healthcare systems.

“ctDNA surveillance may allow earlier detection of cancer recurrence or progression, and therefore earlier intervention, which may improve patient survival,” said Dr. Jonathan Loree, Medical Oncologist at BC Cancer and Assistant Professor at the University of British Columbia. “In addition, because utilizing ctDNA for ongoing clinical management has the potential to reduce healthcare expenditures, our partnered research with Personalis will assess the costs of ctDNA-based surveillance compared to MRI/CT based surveillance.”

“We believe the clinical management of cancer can substantially improve with early determination of patient response and by accurately informing changes to treatment regimens. Such determinations offer the potential to avoid unnecessary toxicities, improve cost-effectiveness, and increase survival,” said Dr. Richard Chen, MD, Chief Medical Officer and Senior Vice President of R&D at Personalis. “By collaborating with researchers at BC Cancer on this multifaceted study, we hope to accelerate advances in oncology practice via ultra-sensitive MRD detection.”

Approximately 220 patients will be recruited for this study from across British Columbia to assess how ctDNA can improve cancer care delivery.

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

Personalis, Inc. is a leader in advanced cancer genomics, 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 sample. To enable cancer 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 the Personalis website and follow Personalis on LinkedIn and Twitter.

About BC Cancer

BC Cancer, a program of the Provincial Health Services Authority, is committed to reducing the incidence of cancer, reducing the mortality from cancer and improving the quality of life of those living with cancer. It provides a comprehensive cancer control program for the people of British Columbia by working with community partners to deliver a range of oncology services, including prevention, early detection, diagnosis and treatment, research, education, supportive care, rehabilitation and palliative care. For more information, visit www.bccancer.bc.ca or follow us on Twitter @BCCancer.

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 BC Cancer, 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, the company’s registration statement on Form S-3 filed on December 30, 2020, and the company’s prospectus supplement filed on January 3, 2022, and include those listed under the caption “Risk Factors.” Personalis disclaims any obligation to update such forward-looking statements.

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