Personalis Launches NeXT Personal® Dx for Early Access Clinical Use in Residual Disease and Recurrence Detection in Cancer
26 Octobre 2023 - 2:15PM
Business Wire
- NeXT Personal Dx is an ultra-sensitive test for detecting
cancer from a blood sample
- Clinical data from groundbreaking TRACERx lung cancer study
demonstrates significant sensitivity and lead time improvements in
detecting cancer
Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics
for precision oncology, announced today the launch of the Early
Access Program for NeXT Personal Dx, a tumor-informed, whole
genome-based liquid biopsy laboratory developed test (LDT) for
detection of molecular residual disease (MRD) and recurrence in
cancer. Designed to help oncologists detect cancer recurrence
earlier and aid in treatment decision-making, NeXT Personal Dx is
poised to reshape the clinical use of MRD testing by delivering
unmatched sensitivity down to the level of one circulating tumor
DNA (ctDNA) molecule in a million.
“Our ultra-sensitive NeXT Personal Dx test has the ability to
reveal previously hidden traces of residual cancer, helping to
reduce uncertainty for physicians and patients,” said Chris Hall,
President and CEO of Personalis. “We’re excited to work with
oncologists through this Early Access Program to detect cancer even
earlier and increase confidence in clinical decisions. We have
several MDs that have expressed interest and we are already
receiving samples.”
NeXT Personal Dx features:
- Unprecedented sensitivity and specificity:
Industry-leading analytical sensitivity, detecting down to ~1 PPM
(parts per million) or 1x10-6 tumor fraction and >99.9%
analytical specificity
- Whole genome-based tumor-informed assay: Selects up to
1,800 variants to design a highly sensitive and specific
personalized tumor signature for each patient
- NeXT SENSE™ technology: Proprietary Signal Enhancement
and Noise Suppression Engine that, together with the personalized
tumor signature, enables ultra-sensitive detection
The NeXT Personal Dx test is currently available through an
Early Access Program to a limited number of clinical customers as
the company builds clinical evidence and achieves Medicare
reimbursement. The EAP will enable oncologists to access NeXT
Personal Dx for clinical use, with a focus on lung cancer, breast
cancer, and immunotherapy response monitoring.
Personalis also recently announced data from the groundbreaking
TRACERx study investigating the use of NeXT Personal in early-stage
lung cancer for MRD and recurrence detection. Personalis, along
with collaborators from Cancer Research UK’s Cancer Research
Horizons, University College London (UCL), and the Francis Crick
Institute, presented data at the 2023 European Society for Medical
Oncology (ESMO) Congress showing the ability of NeXT Personal to
detect lung cancer more sensitively and identify cancer recurrence
with a median lead time of approximately 6 to 11 months ahead of
traditional imaging, and significantly longer than previous TRACERx
results.
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/20231026129472/en/
Investors: Caroline Corner investors@personalis.com
415-202-5678
Media Contact: pr@personalis.com
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