NeXT Personal® ctDNA assay shown to be more
sensitive and predictive of clinical outcomes in early-stage lung
cancer patients
Demonstrates importance of an ultra-sensitive
ctDNA approach
Personalis, Inc. (Nasdaq: PSNL), a leader in precision oncology,
today announced the presentation of initial findings from its work
with the groundbreaking TRACERx lung cancer study, marking a
substantial advancement in lung cancer circulating tumor DNA
(ctDNA) detection and management. The Personalis NeXT Personal
cancer assay, created to detect and monitor residual and recurrent
disease (MRD), demonstrated significantly improved detection rates
for early-stage lung cancer, including lung adenocarcinoma (LUAD),
one of the most common and challenging subtypes of non-small cell
lung cancer (NSCLC) to identify in blood samples.
The findings come from an analysis by Professor Charles Swanton,
Dr. James Black, and other members of the TRACERx consortium,
renowned for their work on the complexities of cancer genomics. The
findings were presented by Dr. Black at the 2023 European Society
for Medical Oncology (ESMO) Congress on October 21 in Madrid,
Spain, and are the first publicly presented results from
Personalis’ collaboration with Cancer Research UK’s Cancer Research
Horizons, University College London (UCL), and the Francis Crick
Institute.
Lung cancer is the second most common cancer in the U.S., with
an estimated 238,000 new cases and approximately 127,000 deaths
forecasted for 2023. The current standard of care for relapse
detection of NSCLC, the most common type of lung cancer, is
primarily focused on imaging modalities such as CT scans, which are
known to be limited in sensitivity. This ongoing collaboration is
focused on addressing this challenge through advanced ctDNA
analysis. For the current analysis, the teams used NeXT Personal to
identify and track MRD in over 170 patients from the TRACERx
cohort.
Higher sensitivity for early-stage lung cancer
In this analysis, NeXT Personal showed significantly higher
sensitivity in early-stage NSCLC patients compared to two previous
publications on the TRACERx cohort. Pre-surgery, the assay
demonstrated 100% sensitivity for ctDNA in pre-surgical non-LUAD
samples and 81% pre-surgical ctDNA sensitivity for LUAD, one of the
most common types of lung cancer but also one of the most
challenging to detect in blood. The pre-surgical sensitivity for
early-stage LUAD was up to 4X higher than in previous studies on
the TRACERx cohort, depending on stage. This high sensitivity
enhanced the assay’s ability to detect recurrence and monitor lung
cancer effectively.
Ability to identify low and high recurrence risk prior to
surgery
The study demonstrated that pre-surgical ctDNA levels with NeXT
Personal could be used to classify early-stage lung cancer patients
into lower- and higher-recurrence risk groups. Furthermore, the
analysis showed that the ultra-low levels of ctDNA detection
enabled by NeXT Personal were critical to determining patient
recurrence risk. For example, LUAD patients who were ctDNA-negative
before surgery with NeXT Personal strikingly exhibited a 100%
5-year overall survival rate and 94% relapse-free survival rate in
the TRACERx cohort. In comparison, patients who were ctDNA-positive
prior to surgery had a high risk of cancer recurrence over 5
years.
Earlier detection for earlier potential intervention
The results presented at ESMO also showed that NeXT Personal
enabled earlier detection of residual or recurrent lung cancer
after surgery in the TRACERx cohort. The results show a median lead
time of approximately 6 to 11 months for ctDNA detection ahead of
traditional imaging, and significantly longer than previous TRACERx
results. The ability to identify potential recurrence months
earlier offers the possibility to intervene and accelerate
treatment in high-risk patients.
The promise of helping lung cancer patients throughout their
journey
Overall, the TRACERx results raise the potential of using NeXT
Personal to help inform patient management throughout the patient
journey, from pre-surgery to post-surgery and longer-term
monitoring.
"Existing tests for lung cancer patients often fall short in
detecting residual or recurrent cancer early. Our NeXT Personal
test is designed to change that by being significantly more
sensitive. We are thrilled that the TRACERx results presented at
ESMO demonstrated higher sensitivity for the most common types of
early-stage lung cancer, including the most challenging subtypes.
That sensitivity translated into a better understanding of
recurrence risk for patients, and earlier detection of recurrence.
We hope that earlier detection can ultimately be life-saving,
offering patients a greater chance at successful treatment," said
Richard Chen, MD, MS, Chief Medical Officer and Executive Vice
President, R&D of Personalis.
The NeXT Personal technology leverages whole genome sequencing
and advanced noise suppression with NeXT SENSE™ technology to
identify a unique genetic signature derived from a patient’s tumor
based on up to ~1,800 variants. This unique signature is tracked in
the patient’s blood over time to find residual or recurrent cancer,
achieving an industry-leading sensitivity of down to ~1 PPM. This
enhanced sensitivity offers the potential for earlier recurrence
risk assessment and intervention, earlier detection, more precise
monitoring, and substantial advancement in lung cancer care.
"Patients often live in fear of undetected cancer leading to a
relapse. Our new assay is a transformative leap forward—it's like
turning on a spotlight in a previously dark room. It finds what
other tests often miss, providing a new level of certainty and
peace of mind. This isn't just about technology; it's about giving
patients and their families a clearer path forward in their fight
against cancer," said Chris Hall, President and CEO of
Personalis.
Webcast and Conference Call Information
Personalis will host a conference call on Tuesday, October 24,
2023 at 6:00 a.m. Pacific Time / 9:00 p.m. Eastern Time. The live
webinar, which includes presentation slides, can be accessed here,
or at https://investors.personalis.com. A replay of the webinar
will be available shortly after the conclusion of the call and will
be archived on the company's website.
About Personalis, Inc.
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 X
(Twitter).
Personalis Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. 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. Such forward-looking statements
involve known and unknown risks and uncertainties and other factors
that may cause actual results to differ materially from any
anticipated results or expectations expressed or implied by such
statements, including the risks, uncertainties and other factors
that relate to Personalis’ ability to demonstrate attributes or
advantages of NeXT Personal or the Personalis NeXT Platform. These
and other potential risks and uncertainties that could cause actual
results to differ materially from the results predicted in these
forward-looking statements are described under the captions “Risk
Factors” and “Management’s Discussion and Analysis of Financial
Condition and Results of Operations” in Personalis’ Annual Report
on Form 10-K for the year ended December 31, 2022, filed with the
Securities and Exchange Commission (SEC) on February 23, 2023, and
its Quarterly Report on Form 10-Q for the quarter ended June 30,
2023, filed with the SEC on August 8, 2023. All information
provided in this release is as of the date of this press release,
and any forward-looking statements contained herein are based on
assumptions that we believe to be reasonable as of this date. Undue
reliance should not be placed on the forward-looking statements in
this press release, which are based on information available to us
on the date hereof. Personalis undertakes no duty to update this
information unless required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20231021966799/en/
Investors: Caroline Corner investors@personalis.com
415-202-5678
Media Contact pr@personalis.com
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