Personalis and UCSF to Study Clinical Utility of ctDNA for Treatment Response in Colorectal Cancer
November 30 2022 - 08:55AM
Business Wire
Personalis, Inc. (Nasdaq: PSNL) today announced a collaboration
with UC San Francisco (UCSF) that will deploy a personalized liquid
biopsy-based research use only (RUO) assay for a study of patients
with colorectal cancer. The research efforts will use Personalis’
NeXT Personal™ assay to evaluate circulating tumor DNA
(ctDNA)-based signatures associated with treatment response and
adverse events in a cohort of late-stage colorectal cancer patients
receiving capecitabine together with pembrolizumab and
bevacizumab.
Colorectal cancer is among the top five most prevalent and
deadly malignancies worldwide. The efficacy of combined targeted
therapy approaches varies widely, reflecting the need for more
sophisticated predictive measures. Typical ctDNA assays in use
today lack sufficient sensitivity for detecting cfDNA-based
biomarkers due to extensive disease heterogeneity, potentially low
levels of signal from small metastases, and the wide range of
mutational profiles relevant to different types of cancer.
“Assessment of early response and adaptive resistance both
critically require a non-invasive liquid biopsy-based assay that
can confidently detect changes in the abundance and mutational
profile of cancer cells. Through serial monitoring of ctDNA, we
will develop greater understanding of patient response to therapy
and use these data to inform the development of signatures
predictive of response,” said Lawrence Fong, MD, the Efim Guzik
Distinguished Professor in Cancer Biology at UCSF and leader of the
Cancer Immunotherapy Program.
“The increased sensitivity of NeXT Personal will make it
possible to identify complete response/absence of disease and
recurrence earlier than existing technologies. Further, by
leveraging the plasma sampling in this cohort, we aim to determine
optimal sample collection timing for early identification of
complete response and demonstrate clinical utility. Additionally,
we seek to demonstrate earlier detection of disease recurrence,
providing support for future interventional studies that can use
this information to make rapid changes to treatment,” said Richard
Chen, MD, Chief Medical Officer and Senior 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
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.
UC Disclaimer
The information stated above was prepared by Personalis, Inc.
and reflects solely the opinion of the corporation. Nothing in this
statement shall be construed to imply any support or endorsement of
Personalis, or any of its products, by The Regents of the
University of California, its officers, agents and employees.
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 UCSF, 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221130005222/en/
Investor Relations Contact for Personalis: Caroline
Corner investors@personalis.com 415-202-5678
Media Contact for Personalis: Jennifer Temple
pr@personalis.com 650-752-1300
Personalis (NASDAQ:PSNL)
Historical Stock Chart
From Oct 2023 to Nov 2023
Personalis (NASDAQ:PSNL)
Historical Stock Chart
From Nov 2022 to Nov 2023