Explanation of Frequently Used Terms in connection with the Parsortix® system



Antibody A protein made by white blood cells in response to an antigen (a toxin or foreign substance). Each antibody can bind to only one specific antigen. The purpose of this binding is to help destroy the antigen
Biomarker A biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how a disease is developing or how well the body responds to a treatment for a disease or condition. Also called molecular marker and signature molecule
Biopsy Process by which cancer cells are removed from the tumor for molecular analysis
Cancer A term for diseases in which abnormal cells divide without control and can invade nearby tissues. Cancer cells can also spread to other parts of the body through the blood and lymph systems
Capture Process for capturing target cells from sample
Capture efficiency Proportion of target cells captured
CD45 The CD45 antibody recognises the human CD45 antigen, also known as the leukocyte common antigen. WBC are CD45+ whereas CTCs are CD45-. Staining with CD45 often used as a negative confirmation that CTCs are not WBC
Cell(s) In biology, the smallest unit that can live on its own and that makes up all living organisms and the tissues of the body. The human body has more than 30 trillion cells
Cell-free DNA Genomic DNA found in the plasma
Cell labelling Technique involving the staining of target cells with fluorescent and/or chromogenic markers for cell identification
Cell lines Cultured cells
CE Mark Regulatory authorisation for the sale of products for clinical use in the European Union
Circulating tumor cell Cancer cell that is circulating in the patient’s blood
CTC Circulating tumor cell
CTC labelling CTCs are often labelled with three markers and are formally identified as CTCs if they are CK+, CD45-, DAPI+
ctDNA or cfDNA Abbreviation for circulating tumor DNA also known as cell-free DNA
Chemotherapy The treatment of cancer by chemicals (drugs). In cancer care the term usually means treatment with drugs that destroy cancer cells or stop them from growing.
Clinical study A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease
CLIA Laboratory The Clinical Laboratory Improvement Amendments (CLIA) of 1988 are federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States (with the exception of clinical trials and basic research). A clinical laboratory is defined by CLIA as any facility which performs laboratory testing on specimens obtained from humans for the purpose of providing information for health assessment and for the diagnosis, prevention, or treatment of disease.
Companion diagnostic A medical device which provides information that is essential for the safe and effective use of a corresponding drug or biological product
CK Cytokeratin
CK+ A cell positive for the presence of cytokeratin protein or mRNA with the presence of distinct cytokeratins often used to identify epithelial cells
Clinical application Use in treating patients
Clinical samples Patient samples usually blood
Clinical use Use in treating patients
Cultured cells Cultured cells grown in the laboratory from human-derived cells used for experimental work
Cytokeratin Cytokeratins are family of intracytoplasmic cytoskeleton proteins with members showing tissue specific expression
DAPI A nuclear stain that is often used to identify the nucleus in a cell
DEPArray™ A commercial single cell isolation system
Diagnostic test A type of test used to help diagnose a disease or condition
DNA Deoxyribonucleic acid (DNA) the molecule that encodes the genetic instructions used in the development and functioning of all known living organisms and many viruses
Downstream technologies Technologies used to undertake molecular analysis of harvested cells after the separation has taken place
EGFR The epidermal growth factor receptor – a signalling molecule which is typically present on the cell surface and can control cell activity including cell proliferation. Mutations in EGFR or deregulation have been associated with a number of cancers including ~30% of all epithelial cancers
Enrichment Generic term for concentrating target cells or molecules in a starting heterogeneous mixture
EpCAM The EpCAM protein is found spanning the membrane that surrounds epithelial cells, where it is involved in cell adhesion
EpCAM+ cells Cells that express EpCAM. CTCs can be either EpCAM+ or EpCAM-
Epithelial cells Cells that line the surfaces and cavities of the body
Epithelial-mesenchymal transition Process by which epithelial cells lose their cell polarity and cell-cell adhesion, and gain migratory and invasive properties to become mesenchymal cells. EMT is thought to occur as part of the initiation of metastasis and is often responsible for cancer progression
EMT Epithelial-mesenchymal transition
Epitope A part of a molecule to which an antibody will bind
FDA U.S. Food and Drug Administration responsible for authorised medical products in the United States
FDA 510(k) A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to Premarket Approval. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims
Genome Genetic material of an organism. The genome includes both protein coding and non-coding sequences
Genotyping Process of determining differences in the genetic make-up (genotype) by examining the DNA sequence
Harvest Process for recovering captured cells from the separation system to allow molecular analysis
Harvest efficiency Proportion of target cells harvested
Harvest purity The number of target cells (such as CTCs) in the harvest as a proportion of the WBC. The minimum purity from which downstream analysis is possible is 0.5%. Analysis of one target cell therefore requires no more than 200 WBC be in the harvest
HER2 A member of the epidermal growth factor receptor (EGFR/ERBB) family. Amplification or overexpression of HER2 has been shown to play an important role in the development and progression of certain aggressive types of breast cancer. In recent years the protein has become an important biomarker and target of therapy for ~ 30% of breast cancer patients
Heterogeneity A word that signifies diversity
HNV Healthy normal volunteer
HT29 Cultured colorectal cancer cell line
Immunotherapy Treatment that stimulates the body’s immune system to fight cancer
In-cassette labelling or in-situ labelling CTC labelling for cell identification undertaken inside the separation system
In vitro diagnostic An in vitro diagnostic is a method of performing a diagnostic test outside of a living body in an artificial environment, usually a laboratory
Key Opinion Leader Key Opinion Leaders (KOLs) are research centers and/or physicians who have strong credentials and are experts in their fields and influence their peers’ medical practice. They lend credibility to efficacy, performance and results and are instrumental in developing clinical applications
KRAS A signalling molecule frequently mutated in the development of many cancers
Leukocytes White blood cells
Liquid biopsy Term used for the process of obtaining cancer cells (or cell-free DNA) from a blood sample. Unlike solid biopsy, liquid biopsy is non-invasive and repeatable
Lysis The breaking down of a cell, often by viral, enzymatic, or osmotic mechanisms that compromise its integrity
Marker A diagnostic indication that disease may develop or is already present. A chemical substance produced by a cancer and used to monitor the progress of the disease. These chemicals are usually measured by a blood test
Mesenchymal CTCs CTCs generally lacking epithelial markers with mesenchymal features
Metastasis Spread of a cancer from one site to another
Microfluidic device An instrument that uses very small amounts of fluid on a microchip to do certain laboratory tests. A microfluidic device may use body fluids or solutions containing cells or cell parts to diagnose diseases.
Molecular analysis Analysis of DNA, RNA and protein often used to determine the mutational status of a patient
mRNA Messenger RNA used to direct the synthesis of proteins
Mutation A gene mutation is a permanent change in the DNA sequence that makes up a gene. Gene mutations can be inherited from a parent or can happen during a person’s lifetime. Mutations passed from parent to child are called hereditary or germline mutations. Mutations that happen during a person’s life, known as somatic mutations, can be caused by environmental factors such as ultraviolet radiation from the sun. Or they can occur if a mistake is made as DNA copies itself during cell division.
Mutational analysis Testing for the presence of a specific mutation or set of mutations
NICE Abbreviation for the National Institute for Health and Care Excellence
Non-invasive In medicine, it describes a procedure that does not require inserting an instrument through the skin or into a body opening. Although a needle is inserted to draw blood, liquid biopsies are referred to as non-invasive as they do not require surgery
NSCLC Non Small Cell Lung Cancer
Off-chip labelling CTC labelling for cell identification of harvested cells undertaken outside the separation system
Paired samples Two related samples often used to compare different systems
Patient study A type of research study, on a smaller scale than a clinical study, that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease
Personalised cancer care Treating a patient individually based on their personal data often including mutational and disease status
Plasma Pale-yellow liquid component of blood obtained following removal of cells
Precision medicine The customisation of healthcare—with medical decisions, practices, and/or products being tailored to the individual patient. In this model, diagnostic testing is often employed for selecting appropriate and optimal therapies based on the context of a patient’s genetic content or other molecular or cellular analysis.
Pre-labelled cell lines Cells which are labelled often with a fluorescent label to facilitate identification during analysis or enrichment
Protein A molecule made up of amino acids. Proteins are needed for the body to function properly. They are the basis of body structures, such as skin and hair, and of other substances such as enzymes, cytokines, and antibodies.
Protein expression Refers to the production of proteins by cells. The study of protein expression in cancer cells may give information about a specific type of cancer, the best treatment to use, and how well a treatment works
Protocol A detailed plan of a scientific or medical experiment, treatment, or procedure. In clinical studies, it states what the study will do, how it will be done, and why it is being done. It explains how many people will be in the study, who is eligible to take part in it, what study drugs or other interventions will be given, what tests will be done and how often, and what information will be collected
Purity The relative absence of extraneous matter in a sample
Regulatory authorisation The authorisation by the appropriate regulatory body for a specific territory that allows an in vitro diagnostic product to be sold for clinical use in that territory.
Relapse When an illness that has seemed to be getting better, or to have been cured, comes back or gets worse again
Remission If a cancer is in remission, there is no sign of it in examinations or tests. Generally, the longer the remission, the less likely it is that the patient will relapse
Research use Sales can be made to certain organisations of in vitro diagnostic products without the need for regulatory authorisation provided they are labelled as Research Use Only (RUO) or Investigational Use Only (IUO)
RNA Ribonucleic acid performs multiple vital roles in the coding, decoding, regulation, and expression of genes. Together with DNA, RNA comprises the nucleic acids, which, along with proteins, constitute the three major macromolecules essential for all known forms of life
Sensitivity Refers to the percentage of people who test positive for a specific disease or condition among people who actually have the disease or condition
Separation Term used for processing of a sample through the Parsortix system
Single cell analysis Extraction of a single target cell from the harvest for analysis
Solid biopsy Standard process for surgically excising (cutting out) cells from a solid tumor when that tumor is accessible
Specificity Refers to the percentage of people who test negative for a specific disease or condition among a group of people who do not have the disease or condition
Spiked cell experiments Experiments where cultured cells are added (spiked) to HNV blood to assess the capture and harvest efficiency of the system
Translational research A term used to describe the process by which the results of research done in the laboratory are used to develop new ways to diagnose and treat disease
Tumor/Tumour An abnormal mass of tissue that results when cells divide more than they should or do not die when they should. Tumours may be benign (not cancer), or malignant (cancer).Tumor is the American English spelling and Tumour is the standard English spelling
Tumour heterogeneity Describes the observation that different tumor cells can show distinct morphological and phenotypic profiles, including cellular morphology, gene expression, metabolism, motility, proliferation, and metastatic potential. This phenomenon occurs both between tumors (inter-tumor heterogeneity) and within tumors (intra-tumor heterogeneity). The heterogeneity of cancer cells introduces significant challenges in designing effective treatment strategies.
Tumour marker A substance found in tissue, blood, or other body fluids that may be a sign of cancer or certain benign (non-cancerous) conditions. Most tumor markers are made by both normal cells and cancer cells, but they are made in larger amounts by cancer cells. A tumor marker may help to diagnose cancer, plan treatment, or determine how well treatment is working or if the patient has relapsed.Examples of tumor markers include CA-125 (in ovarian cancer), CA 15-3 (in breast cancer), CEA (in colon cancer), and PSA (in prostate cancer).
WBC White blood cells
WGA Whole genome amplification
Whole genome amplification Method for amplification of an entire genome necessary for the picogram amounts of genomic DNA present in a single cell
Xenograft The transplant of an organ, tissue, or cells to an individual of another species