PLYMOUTH, MI: DeNovo Sciences, Inc. an innovator of cutting edge products in liquid biopsy announced the findings of clinical breast cancer study conducted at Thomas Jefferson University. The study, published as an abstract at the San Antonio Breast Cancer Symposium in December, revealed that the DeNovo Sciences’ circulating tumor cell (CTC) platform results are consistent with the FDA approved Cell Search diagnostic platform made by Janssen Diagnostics, LLC.
The study was conducted on 31 metastatic breast cancer patients enrolled between March and June 2014. CTC detection by the DeNovo microfluidic platform was more positively associated with HER2 positive patients compared to the CellSearch® system. The two methods were concordant 84% (k=0.678) when a cutoff of =5 cells per 7.5 ml of blood was used to identify patients at a higher risk of disease progression.
“The new microfluidific system showed accuracy and flexibility and has the potential to become a viable and informative alternative to existing approaches,” said senior author of the study Dr. Paolo Fortina, Director, Cancer Genomics Laboratory, Sidney Kimmel Cancer Center, Thomas Jefferson University.
Circulating tumor cells, which are cells that have detached from the primary tumor and shed into the bloodstream, have been implicated in the spread of cancer or metastasis. Research has shown that counting the CTCs in a patient’s blood sample can predict progression-free survival (PFS) and overall survival (OS) in several cancers types. However, CTCs also harbor molecular and genetic information about the tumor, which could allow physicians to detect changes in the cancer’s behavior and drug susceptibility through a simple blood test.
“As clinicians, we look forward to being able to analyze CTCs on the molecular level,” said Dr. Massimo Cristofanilli, Director of the Jefferson Breast Care Center, whose research established the prognostic value of CTC in 2004 (N Engl J Med. 2004, 351:781-91). “That information could help reveal opportunities for effective treatment in a patient.”
DeNovo Sciences offers the a fully automated CTC detection system that has the ability to analyze biomarkers at the single cell level. Molecular and genetic analysis of a cancer is crucial to developing a personalized treatment plan. In addition, DeNovo’s patented label-free capture system ensures that there will be unlimited assay menu expansion opportunity. Reducing manual handling alleviates contamination issues and makes the process more precise, accurate and reliable. The DeNovo CTC platform is currently undergoing preparations for a 510 K FDA approval process.
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About DeNovo Sciences, Inc.
DeNovo Sciences, Inc., a privately held Michigan based company, develops automated microfluidic systems for rare cell enrichment and single cell analysis. The Company is focused on detecting, analyzing and imaging Circulating Tumor Cells (CTC) as a companion to or in some cases a possible replacement to cancer biopsies. The Company’s sample preparation and imaging systems along with their reagent kits is an industry first. The JETTA 400 system performs all the required processing steps to isolate and preforms downstream single cell analysis to include Immunochemistry, DNA FISH, mRNA, and PCR while the VanGuard analysis the prepared slide automatically. This innovation allows the Healthcare Professional more time to focus on their patient’s therapeutic treatment and outcome.
Visit www.denovosciences.com to learn more and view the poster.
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