Congruence Study Between Two ctDNA Liquid Biopsy Testing in mBC Patients and Prognostic Value in Combination with CTCs, Investigators to Report at SABCS 2018

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Study from Northwestern University demonstrates consistent ctDNA assay performance between PredicinePlus™ and Guardant360™

Predicine is a molecular insights company that is committed to developing the best-in-class precision diagnostics and precision medicine portfolio to address the unmet medical needs worldwide

"Our studies clearly demonstrate the much-warranted concordance in the performance of commercial ctDNA assays with similar sensitivity, which is essential for ctDNA’s standard clinical use."

Liquid biopsies are being widely studied as a minimally-invasive means for early detection of cancer, monitoring of disease progression, and guiding treatment decisions. However, recent studies in JAMA Oncology reported the discordance between circulating tumor DNA (ctDNA) assay results from commercial platforms such as Guardant Health and PGD, raising questions and concerns regarding the performance of liquid biopsy platforms and its clinical utility in patient care.

In this week’s SABCS annual conference, clinicians and scientists from Northwestern University present an independent study that shows consistent results between Guardant Health and Predicine ctDNA assay platforms. Specifically, both PredicinePLUS™ and Guardant360™ ctDNA assays identified similar type of genomic alternations in metastatic breast cancer (mBC) patients. The authors concluded that there was no significant difference observed with regards to % ctDNA and number of variants between PredicinePLUS™ and Guardant360™. Of note, the ctDNA results from the 180-gene PredicinePLUS™ assay additionally demonstrate a significant correlation with treatment response and overall survival.

In a separate study that shares the same patients from the above study, researchers from Northwestern University present a combined analysis of circulating tumor cells (CTC) enumeration and ctDNA and observed a significant correlation between molecular features of aggressive disease as described by PredicinePLUS™ ctDNA alterations and prognostic value of CTCs from the FDA-cleared CELLSEARCH®. The authors concluded that evaluation of both components of liquid biopsy, CTCs and ctDNA are necessary to shed new lights into mechanisms of metastasis for mBC patients and improve treatment selection and monitoring.

“Liquid biopsy is the future of precision medicine. Our studies clearly demonstrate the much-warranted concordance in the performance of commercial ctDNA assays with similar sensitivity, which is essential for ctDNA’s standard clinical use,” said the lead investigator, Massimo Cristofanilli, M.D., of Northwestern University and President of International Society of Liquid Biopsy. “The findings from these studies are very encouraging and reassuring for the field of liquid biopsy and support the further clinical development and clinical application for patient care.”

Complete results from the study will be presented at SABCS on November 7, 2018 in accordance with the SABCS embargo policy.

Poster Sessions:

Title: Characterization of circulating tumor free DNA (ctDNA) obtained from patients with metastatic breast carcinoma (MBC) undergoing systemic therapies using comprehensive genomic profiling
Abstract: P4-01-08
Session: Poster Session 4: Detection/Diagnosis: Circulating BioMarkers & ctDNA
Date/Time: Friday, December 7, 2018 - 7:30 am
Room: Hall 1

Title: Correlation between circulating tumor DNA (ctDNA) alterations and circulating tumor cells (CTC) uncovers new mechanisms of metastasis for patients with metastatic breast carcinoma (MBC)
Abstract: P4-01-18
Session: Poster Session 4: Detection/Diagnosis: Circulating BioMarkers & ctDNA
Date/Time: Friday, December 7, 2018 - 7:30 am
Room: Hall 1

About PredicinePLUS™
Powered by Predicine’s GeneRADAR technology, PredicinePLUS™ is a 180-gene NGS liquid biopsy panel that detects somatic tumor mutations in circulation, which can utilize cfDNA, cfRNA or both to identify RNA- and DNA-based SNVs, INDELS, fusions, and RNA splicing variants. The test has been used in clinical trials to monitor treatment response, resistance, and survival.

About Predicine
Predicine is a molecular insights company that is committed to developing the best-in-class precision diagnostics and precision medicine portfolio to address the unmet medical needs worldwide. Predicine’s proprietary GeneRADAR technology is the industry’s first ctDNA+ctRNA combo liquid biopsy test that provides a comprehensive understanding of the molecular alterations in cancer. Through its CLIA/CAP facilities in US (California) and China (Shanghai, Harbin), Predicine partners with leading biopharma companies and hospitals to support global clinical trials, targeted therapy, and early cancer detection. For more, please visit predicine.com and follow Predicine on Twitter @Predicine.

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Annie Chen
@predicine
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