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Personalis Selected for Clinical Research After Successful Evaluation of Whole Genome-Based Molecular Residual Disease Assay

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Personalis, Inc. (Nasdaq: PSNL) announced an ongoing collaboration with AstraZeneca (LSE/STO/Nasdaq: AZN) to explore ultra-sensitive molecular residual disease (MRD) measurement using Personalis' NeXT Personal® assay. This partnership aims to enhance the detection of circulating tumor DNA (ctDNA) and clinically relevant mutations to guide cancer therapy. The CALLA trial will focus on locally advanced cervical cancer, assessing the roles of ctDNA and HPV detection in plasma. Personalis emphasizes the assay's high sensitivity and specificity, crucial for early and personalized patient interventions.

Positive
  • Continued collaboration with AstraZeneca enhances credibility and potential market reach.
  • NeXT Personal assay aimed at ultra-sensitive MRD detection may establish a strong position in precision oncology.
  • CALLA trial could lead to significant advancements in early cancer detection and treatment personalization.
Negative
  • None.

Company Will Explore Use of NeXT Personal® in AstraZeneca Trial

FREMONT, Calif.--(BUSINESS WIRE)-- Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced it will continue its collaboration with AstraZeneca (LSE/STO/Nasdaq: AZN), a global science-led biopharmaceutical company, to explore ultra-sensitive molecular residual disease (MRD) measurement, including clinically relevant and personalized variant tracking, for clinical research and drug development.

The two companies are collaborating to evaluate the sensitivity and specificity potential of whole-genome-informed circulating tumor DNA (ctDNA) testing, while simultaneously detecting and quantifying clinically relevant mutations in ctDNA that may be used in the future to help guide therapy when cancer is detected. One trial, called CALLA, will investigate the role of ctDNA and HPV detection in plasma in locally advanced cervical cancer.

"Personalis designed NeXT Personal to provide ultra-high sensitivity and specificity for MRD detection. Our whole-genome, tumor-informed approach improves ctDNA measurement even when the plasma tumor fraction is exceptionally low, which is the case in multiple cancers with low mutational burden. We are pleased that AstraZeneca is prioritizing such sensitivity, with the aim of enabling earlier and more personalized interventions for patients," said Christopher Hall, President and CEO of Personalis.

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.

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.

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 AstraZeneca, 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.

Investors:

Caroline Corner

investors@personalis.com

415-202-5678



Media:

Jennifer Temple

pr@personalis.com

650-752-1300

Source: Personalis, Inc.

FAQ

What is the purpose of the collaboration between Personalis and AstraZeneca?

The collaboration aims to explore ultra-sensitive MRD measurement using Personalis' NeXT Personal assay, focusing on improving cancer detection and therapy guidance.

What is the CALLA trial about?

The CALLA trial investigates the role of ctDNA and HPV detection in plasma for detecting locally advanced cervical cancer.

What are the key benefits of the NeXT Personal assay?

The NeXT Personal assay provides ultra-high sensitivity and specificity for MRD detection, tracking therapy resistance, and differentiating between responders and non-responders.

How might this collaboration impact Personalis' stock (PSNL)?

Successful results from the collaboration and trial could enhance Personalis' market position and investor confidence, potentially positively impacting PSNL stock performance.

What is the significance of ctDNA testing in oncology?

ctDNA testing is crucial for detecting mutations in tumors, allowing for early diagnosis and personalized treatment strategies in cancer care.

Personalis, Inc.

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Diagnostics & Research
Services-medical Laboratories
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United States of America
FREMONT