CELLSEARCH® System Recognized as Landmark Innovation in Cancer Research
- Seminal Study included in list of Most Significant Publications of past 20 years
in Clinical Cancer Research-
Raritan, N.J., DATE, 2015, - - Janssen Diagnostics today announced that a clinical trial
involving the company’s CELLSEARCH® System has been recognized by the editors of Clinical
Cancer Research1 as being among the most significant studies to appear in the journal in its 20
year history. The study revealed the prevalence of circulating tumor cells (CTCs) in most major
cancers2, and established the analytical accuracy, reproducibility, and linearity of the
CELLSEARCH® System in capturing CTCs. This research demonstrated that the
CELLSEARCH® System could be used as a reliable tool to investigate CTCs and their clinical
utility. The trial, “Tumor cells circulate in the peripheral blood of all major carcinomas but not in
healthy subjects or patients with nonmalignant diseases,” was published in 20043 and ignited
interest in the clinical use of CTC testing.
The FDA cleared the CELLSEARCH® System for use in the management of individuals with
metastatic breast cancer, and subsequently expanded this clearance for use in the
management of individuals with metastatic prostate* and colorectal cancers. To date, the
CELLSEARCH® System remains as the only CTC test to earn FDA clearance for use in patient
management, and has also earned approval by the China FDA for the management of
individuals with metastatic breast cancer.
CTCs are cancer cells that have detached from the tumor and entered the bloodstream.
The highly sensitive and selective CELLSEARCH® System can detect CTCs via a routine
blood test. The trial referenced in Clinical Cancer Research demonstrated that these rare
cells are not present in individuals without cancer. The value of capturing and counting
CTCs continues to evolve as more research data is gathered about the utility of these
markers in monitoring disease progression and potentially guiding more precise and
personalized cancer therapy.
“Studies have repeatedly demonstrated the accuracy of CTC enumeration to predict survival in
patients with metastatic breast, prostate and colorectal cancers,” notes Mark C. Connelly, Ph.D.,
Scientific Director, Janssen Diagnostics and one of the investigators involved in the trial
published in Clinical Cancer Research. “The CELLSEARCH® System can help detect changes
in disease progression at any time which can help oncologists and their patients make more
informed clinical decisions.”
Clinical data from 28 independent prospective studies involving more than 4,700 patients have
validated the clinical performance and value of CELLSEARCH® System CTC testing as a
reliable prognostic factor for progression-free survival and overall survival both before and after
therapy initiation. Data obtained with the CELLSEARCH® System have been published in more
than 100 peer-reviewed publications.
Intended Use: The CELLSEARCH® Circulating Tumor Cell Kit is intended for the enumeration of
CTC of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood.
The presence of CTC in the peripheral blood is associated with decreased progression free
survival and decreased overall survival in patients treated for metastatic breast, colorectal or
prostate* cancer. The test is intended to be used as an aid in the monitoring of patients with
metastatic breast, colorectal or prostate cancer. Serial testing for CTC should be used in
conjunction with other clinical methods for monitoring metastatic breast, colorectal and prostate
cancer. Evaluation of CTC at any time during the course of disease allows assessment of
patient prognosis and is predictive of progression free survival and overall survival.
*Metastatic
prostate cancer patients in this study were defined as having two consecutive
increases in the serum marker PSA above a reference level, despite standard hormonal
management. These patients are commonly described as having androgen-independent,
hormone-resistant, or castration-resistant prostate cancer.
About Janssen Diagnostics
At Janssen Diagnostics we are passionate about the promise of precision medicine and its
potential to improve outcomes for specific patients through targeted therapies.
We aspire to help doctors and researchers better identify, prevent or intervene earlier with
diseases, or cure people with the right medicines for the right person, at the right time.
Being part of Janssen puts us in a strong position, enabling us to bridge Janssen’s extensive
pharmaceutical knowledge-base and global capabilities, with our own heritage and talent in
research technology, diagnostics and health information technology to deliver integrated
solutions into the hands of healthcare providers.
The best way to further our aspirations in the personalized medicine space is to move away
from the traditional business model and adopt a more open model that is based on developing
the best technologies, either in-house or by partnering with those who own them, to ultimately
improve patient outcomes in collaboration with our customers.
What makes Janssen Diagnostics unique is the concentration of minds, personnel and skills at
the heart of Pharma R&D, specifically organized to develop and commercialize products and
services around meeting patient needs of both today and tomorrow.
Notes
1Anderson,
K.C., Potash, J., 2015. Clinical Cancer Research: The 20th Anniversary. Clin. Cancer Res.,
2015;21:3
2These
3Allard,
include metastatic breast, colorectal, prostate, lung, gastric, pancreatic, and ovarian cancers
W.J., Matera, J., Miller, M.C., Repollet, M., Connelly, M.C., Rao, C., Tibbe, A.G.J., Uhr, J.W.,
Terstappen, L.W.M.M., 2004. Tumor cells circulate in the peripheral blood of all major carcinomas but not
in healthy subjects or patients with nonmalignant diseases. Clin. Cancer Res., 10; 6897
Media Contacts:
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Scott Canady
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