@article{c3e5007d9a4a4fbeb815720cf13e66e1,
title = "A Multi-Center Clinical Study to Harvest and Characterize Circulating Tumor Cells from Patients with Metastatic Breast Cancer Using the Parsortix{\textregistered} PC1 System",
abstract = "Circulating tumor cells (CTCs) captured from the blood of cancer patients may serve as a surrogate source of tumor material that can be obtained via a venipuncture (also known as a liquid biopsy) and used to better understand tumor characteristics. However, the only FDA-cleared CTC assay has been limited to the enumeration of surface marker–defined cells and not further characterization of the CTCs. In this study, we tested the ability of a semi-automated device capable of capturing and harvesting CTCs from peripheral blood based on cell size and deformability, agnostic of cell-surface markers (the Parsortix{\textregistered} PC1 System), to yield CTCs for evaluation by downstream techniques commonly available in clinical laboratories. The data generated from this study were used to support a De Novo request (DEN200062) for the classification of this device, which the FDA recently granted. As part of a multicenter clinical trial, peripheral blood samples from 216 patients with metastatic breast cancer (MBC) and 205 healthy volunteers were subjected to CTC enrichment. A board-certified pathologist enumerated the CTCs from each participant by cytologic evaluation of Wright-Giemsa-stained slides. As proof of principle, cells harvested from a concurrent parallel sample provided by each participant were evaluated using one of three additional evaluation techniques: molecular profiling by qRT-PCR, RNA sequencing, or cytogenetic analysis of HER2 amplification by FISH. The study demonstrated that the Parsortix{\textregistered} PC1 System can effectively capture and harvest CTCs from the peripheral blood of MBC patients and that the harvested cells can be evaluated using orthogonal methodologies such as gene expression and/or Fluorescence In Situ Hybridization (FISH).",
keywords = "biomarkers, biopsy, blood, breast neoplasms/pathology, circulating, circulating tumor cells, circulating/pathology, liquid biopsy, neoplasms/diagnosis, neoplastic cells, tumor",
author = "Cohen, {Evan N.} and Gitanjali Jayachandran and Moore, {Richard G.} and Massimo Cristofanilli and Lang, {Julie E.} and Khoury, {Joseph D.} and Press, {Michael F.} and Kim, {Kyu Kwang} and Negar Khazan and Qiang Zhang and Youbin Zhang and Pushpinder Kaur and Roberta Guzman and Miller, {Michael C.} and Reuben, {James M.} and Ueno, {Naoto T.}",
note = "Funding Information: The authors ENC, GJ, KKK, NK, QZ, YZ, PK and RG declare no conflict of interest. RGM reports consulting fees from Fujirebio Diagnostics; MC reports AstraZeneca (Consulting Fees (e.g., advisory boards), Contracted Research) Celcuity (Consulting Fees (e.g., advisory boards)) Eli Lilly (Consulting Fees (e.g., advisory boards), Contracted Research, Fees for Non-CMEServices Received Directly from Commercial Interest or their Agents (e.g., speakers{\textquoteright} bureaus)) Ellipses (Consulting Fees (e.g., advisory boards)) Foundation Medicine (Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers{\textquoteright} bureaus)) Guardant (Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers{\textquoteright} bureaus)) Menarini (Consulting Fees (e.g., advisory boards)) Olaris (Consulting Fees (e.g., advisory boards)) Pfizer (Contracted Research, Fees for Non-CME Services Received Directly from Commercial Interest or their Agents (e.g., speakers{\textquoteright} bureaus)) Semonix (Consulting Fees (e.g., advisory boards)); JEL reports grant from ANGLE (Contracted Research); JDK reports Angle, plc (Consulting Fees (e.g., advisory boards), Contracted Research); MFP reports AstraZeneca (Consulting Fees (e.g., advisory boards)) Biocartis SA (Consulting Fees (e.g., advisory boards)) CEPHEID (Consulting Fees (e.g., advisory boards)) Eli Lilly & Company (Consulting Fees (e.g., advisory boards)) Lilly USA, LLC (Consulting Fees (e.g., advisory boards)) Merck & Co. (Consulting Fees (e.g., advisory boards)) Puma Biotechnology (Consulting Fees (e.g., advisory boards)) TORL BIOTHERAPEUTICS LLC (Ownership Interest (stocks, stock options, patent or other intellectual property or other ownership interest excluding diversified mutual funds)) Zymeworks Inc. (Consulting Fees (e.g., advisory boards)); MCM reports ANGLE plc (Full-time employee, Ownership Interest (stocks, stock options, patent or other intellectual property or other ownership interest excluding diversified mutual funds)); JMR reports Angle plc (Consulting Fees (e.g., advisory boards), Contracted Research); NTU reports Angle plc (Contracted Research) AnHeart Therapeutics Inc. (Consulting Fees (e.g., advisory boards)) AstraZeneca Pharmaceutical (Consulting Fees (e.g., advisory boards)) Carisma Therapeutics, Inc. (Consulting Fees (e.g., advisory boards), Contracted Research) CARNA Biosciences, Inc. (Consulting Fees (e.g., advisory boards)) ChemDiv, Inc. (Consulting Fees (e.g., advisory boards), Contracted Research) Chugai Pharmaceutical (Consulting Fees (e.g., advisory boards)) Daiichi Sankyo, Inc. (Consulting Fees (e.g., advisory boards), Contracted Research) DualityBio (Consulting Fees (e.g., advisory boards), Contracted Research) DynaMed (Consulting Fees (e.g., advisory boards)) Eisai Medical Research Inc (Consulting Fees (e.g., advisory boards), Contracted Research) Epic Science (Contracted Research) Gilead Sciences, Inc. (Consulting Fees (e.g., advisory boards), Contracted Research) Kechow Pharma (Consulting Fees (e.g., advisory boards)) Kirilys Therapeutics, Inc. (Consulting Fees (e.g., advisory boards)) Kyowa Hakko Kirin Co., Ltd. (Speaker) LARVOL (Consulting Fees (e.g., advisory boards)) Merck Co. (Contracted Research) OBI Pharma Inc. (Contracted Research) OncoCyte Co. (Consulting Fees (e.g., advisory boards)) Oncolys BioPharma Inc. (Contracted Research) Ourotech, Inc., DBA Pear Bio (Royalty) Peptilogics, Inc. (Consulting Fees (e.g., advisory boards)) Pfizer Inc. (Consulting Fees (e.g., advisory boards), Contracted Research) Phoenix Molecular Designs (Consulting Fees (e.g., advisory boards)) Preferred Medicine, Inc. (Consulting Fees (e.g., advisory boards), Contracted Research) Rakuten Medical, Inc. (Consulting Fees (e.g., advisory boards)) Sumitomo Dainippon Pharma, Inc. (Contracted Research) Sysmex Co. Ltd. (Consulting Fees (e.g., advisory boards)) Takeda Pharmaceuticals, Ltd. (Consulting Fees (e.g., advisory boards)) Unitech Medical, Inc. (Consulting Fees (e.g., advisory boards)). MCM, a full-time employee of ANGLE North America, Inc., a subsidiary of ANGLE plc, and was involved in the design of the study, the analysis and interpretation of the data, the decision to publish the results, and in the writing of the manuscript. The information and results reported in the manuscript, as well as their interpretations, are based on generally accepted scientific principals and methods and as such were not inappropriately influenced by the commercial interest of the funder (ANGLE Europe Limited). Funding Information: This study was supported by ANGLE Europe Limited. M.F. Press was supported by grants from the Breast Cancer Research Program (BCRF-20, 21, 22-132), Tower Cancer Research Program (Grant Number 006886-0001), Miriam and Sheldon G. Adelson Medical Research Program, and a gift from Richard Balch. Publisher Copyright: {\textcopyright} 2022 by the authors.",
year = "2022",
month = nov,
doi = "10.3390/cancers14215238",
language = "English (US)",
volume = "14",
journal = "Cancers",
issn = "2072-6694",
publisher = "Multidisciplinary Digital Publishing Institute (MDPI)",
number = "21",
}
