Glossary

Analyte

The substance that is being investigated, identified or measured in the analysis/test/assay

Analytical sensitivity

Analytical sensitivity represents the smallest amount of substance in a sample that can accurately be measured by an assay. It can also be viewed as the Limit of Detection (LoD). LoD is the actual concentration of an analyte in a specimen that can be consistently detected ≥ 95% of the time. For ANGLE’s Portrait assays it is the proportion of spiked cells known to express the marker(s) of interest which were marker positive in the assay

Analytical specificity

Analytical specificity is an assay’s ability to detect the intended target. For ANGLE’s Portrait assays it is the proportion of spiked cells known to NOT express the marker(s) of interest which were marker negative in the assay

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

Antibody-drug conjugates

Antibody-drug conjugates (ADCs) are targeted medicines that deliver chemotherapy agents only to cancer cells. ADCs consist of an antibody that binds to a specific biomarker, such as HER2, on the cancer cell. This antibody is linked to a cytotoxic drug, which is then released into the cancer cell, consequently killing it

Antigen

Proteins that can be used as markers in laboratory tests to identify cancerous and normal tissues or cells

AR-V7

The androgen receptor (AR) has been proposed as a mechanism of therapeutic resistance to AR signalling (ARS) inhibitors. Androgen receptor variant 7 (AR-V7) participates in regulating prostate cancer cell proliferation and gene expression and is correlated with drug resistance.

Assay

A laboratory test to find and measure the amount of a specific substance

AUC-ROC

The area under the curve (AUC) for a receiver operating characteristic (ROC) plot, a plot of 1-specificity on the x-axis vs. the sensitivity on the y-axis at each possible threshold for a test’s results, is a measure of a diagnostic test’s accuracy. The accuracy of the test depends on how well the test separates the two groups being compared into those with the outcome (sensitivity) and those without the outcome (specificity) in question. An AUC of 1 (100%) represents a perfect test while an AUC of 0.5 (50%) represents a worthless test. The traditional academic classification system for AUC-ROCs is 90% to 100% = excellent; 80% to 90% = good; 70% to 80% = fair; 60% to 70% = poor; 50% to 60% = fail. Reference for further information : div-class-title-understanding-receiver-operating-characteristic-roc-curves-div.pdf (cambridge.org)

Baseline

An initial measurement of a condition taken at an early timepoint used for comparison over time

Benign

Not cancerous. Benign tumours may grow larger but do not spread to other parts of the body. Also called non-malignant

Biobank

A large collection of biological or medical data collected for research purposes

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

Biopharma

Biopharmaceutical companies collectively as a sector of industry

Biopsy

Process by which cancer cells are removed from the tumour for analysis

Blood lineage markers

Markers are used to identify blood cell types using specific antibodies. This helps to better differentiate between CTCs and blood cells

BRAF

A cell signaling molecule associated with cell growth, proliferation, differentiation, migration, apoptosis and survival. BRAF mutations occur in 15% of all human cancer types

CAGR

Compound Annual Growth Rate. A measure of revenue growth that has been compounded over time

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 a sample

Capture efficiency

Proportion of target cells captured

Carcinogen

Any substance that is directly involved in causing cancer

Cassette

ANGLE’s patent protected microfluidic consumable that captures CTCs

CD45

The CD45 antibody recognises the human CD45 antigen, also known as the leukocyte common antigen. WBC are CD45+ whereas CTCs are CD45-. CD45 staining is often used as a negative confirmation that CTCs are not WBC

CD47

Is known as integrin associated protein and is found on the surface on many cells in the body. The protein tells immune cells not to destroy a cell, helping to protect cells and also to detect aging or diseased cells. It is overexpressed in many types of cancer allowing the cells to avoid death

CDx

Companion diagnostic

CE Mark

Regulatory authorisation for the marketing and sale of products for clinical use in the European Union. The CE mark is the manufacturer’s declaration, following appropriate assessment by a CE Notified Body, that the product meets the requirements of the applicable CE directives

Cell culture

See cultured cells

Cell labelling

Technique involving the staining of target cells with fluorescent and/or chromogenic markers for cell identification

Cell lines

Cultured cells

Cell-free DNA

Genomic DNA found in the plasma

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

CellKeep™ Slide

A unique CTC harvesting technology developed by ANGLE to maximise the retention of CTCs harvested from blood samples for imaging. Use of the CellKeep Slide reduces the volume of antibody needed to stain harvested CTCs thereby reducing processing time and associated costs

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

Circulating tumour cell

Cancer cell that has detached from a tumour and is circulating in the patient’s blood

Circulating tumour DNA

Circulating tumour DNA (ctDNA) is tumour-derived fragmented DNA in the bloodstream that has been released by dead/dying tumour cells

CK

See 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

Class II Classification

The FDA classifies devices on the level of control necessary to ensure their safety and effectiveness. A class II device has a moderate to high associated risk

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

Clinical application

Use in treating patients

Clinical samples

Patient samples, for example, blood

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

Clinical use

Use in treating patients

Clinically actionable biomarker

A genomic biomarker (for example EGFR, HER2) which is a target for one or more FDA approved therapeutic drugs

Clinically actionable DNA variants

A variant (such as a mutation or alteration) of a genomic biomarker which is a target for one or more FDA approved therapeutic drugs

Clinician

A healthcare professional/doctor

Companion diagnostic (CDx)

A medical device which provides information that is essential for the safe and effective use of a corresponding drug or biological product. Also abbreviated as CDx

Comprehensive genomic information

Information gained from profiling large amounts of patient genes including relevant cancer biomarkers and gene alterations to guide the patient pathway

Contract Research Organisation (CRO)

A company hired by another company or research centre to take over certain parts of running a clinical trial.
The company may design, manage and monitor the trial, and analyse the results. Also abbreviated as CRO

Copy number alterations

Changes to chromosome structure that result in a loss or gain in copies of sections of DNA

CRISPR

Clustered regularly interspaced short palindromic repeats, a segment of short repeats that can be used as a gene editing tool

CT

Computerised tomography, a form of diagnostic imaging that combines a series of X-rays

CT scan

A procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body. The pictures are taken from different angles and are used to create three-dimensional views of tissues and organs

CTC clusters

Groups of more than two CTCs that travel together in the bloodstream

CTC labelling

CTCs are often labelled with three markers and are formally identified as CTCs if they are CK+, CD45-, DAPI+

CTC(s)

Circulating tumour cell(s)

ctDNA or cfDNA

Abbreviation for circulating tumour DNA also known as cell-free DNA

Cultured cells

Cultured cells grown in the laboratory from human-derived cells used for experimental work

Cytokeratin (CK)

Cytokeratins are a family of intracytoplasmic cytoskeleton proteins with members showing tissue specific expression

Cytopathological

A branch of pathology that studies and diagnoses diseases at the cellular level, generally used on samples of free cells or tissue fragments

Cytopathology

A branch of pathology involving the study and diagnosis of disease at a cellular level

DAPI

A nuclear stain that is often used to identify the nucleus in a cell

DDR

DNA Damage Repair. A group of cellular restoration processes in response to DNA damage

De Novo

An FDA clearance pathway to classify novel medical devices – see FDA De Novo below

DEPArray™

A commercial single cell isolation system

Diagnosis

The process of identifying a disease, condition or injury from its signs and symptoms. A health history, physical examination and tests, such as blood tests, imaging tests and biopsies, may be used to help make a diagnosis

Diagnostic Leukapheresis (DLA)

Removal of the blood to collect specific blood cells such as leukocytes. The remaining blood is then returned to the body

Diagnostic test

A type of test used to help diagnose a disease or condition

Digital PCR

A third generation of PCR that enables absolute quantification through partitioning the reaction

DNA

Deoxyribonucleic acid (DNA) is the molecule that encodes the genetic instructions used in the development and functioning of all known living organisms and many viruses

DNA damage

A change in DNA structure that can cause cellular injury, or negatively impact cell function/activity

DOMINO

A prostate cancer pre-biopsy study run by ANGLE and MidLantic Urology

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

EMT

Epithelial to mesenchymal transition

Enrichment

Generic term for concentrating target cells or molecules in a starting heterogeneous mixture

Enumeration

To determine the number of; count

EpCAM

The Epithelial Cell Adhesion Molecule (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

Epitope

A part of a molecule to which an antibody will bind

ESR1

Estrogen Receptor 1 gene is essential for sexual development and reproduction, and mutation of this gene may play a role in the development of breast and endometrial cancers

Exploratory endpoint

An endpoint is a targeted outcome of a clinical trial. Exploratory endpoints are to explore new hypotheses

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

FDA Class II Device

Medical devices with an intended use that is considered medium or moderate risk. For non-exempt devices the FDA require a pre-market clearance or approval to be issued before a company can legally market their device. The company will be required to have general medical device quality system controls in place as well as device specific special controls (which may include device labelling and design control processes and documentation)

FDA De Novo

The De Novo process provides a pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device (therefore the FDA 510(k) route does not apply). Devices that are classified into class I or class II through a De Novo classification request may be marketed and used as predicates for future premarket (510(k)) submissions

Fluorescence In-Situ Hybridization (FISH)

A laboratory technique for detecting and locating a specific DNA sequence on genes or chromosome in tissue and cells. The technique relies on exposing genes or chromosomes to a small DNA sequence called a probe that has a fluorescent molecule attached to it. The probe sequence binds to its corresponding sequence on the genes or chromosome and they light up when viewed under a microscope with a special light

Formalin-fixed paraffin-embedded (FFPE)

A form of preservation and preparation for solid tissue biopsy specimens that allows sample evaluation

Gamma-H2AX or γH2AX

A sensitive marker for DNA damage. Specifically, for double-stranded DNA breaks. This can be used to assess treatment

GCLP

Good Clinical Laboratory Practice

Gene amplification

A process in which a gene is duplicated many times

Gene expression

The process by which a gene gets turned on in a cell to make RNA and proteins. Gene expression may be measured by looking at the RNA or the protein made from the RNA

Genome

Genetic material of an organism. The genome includes both protein coding and non-coding sequences

Genomic abnormalities

Changes or rearrangements within the genome that drive disease

Genotyping

Process of determining differences in the genetic make-up (genotype) by examining the DNA sequence

Gleason Score

A system of assessing how aggressive prostate cancer tissue is based on how it looks under a microscope. Gleason scores range from 2 to 10 and indicate how aggressive and fast-growing the cancer is. A low Gleason score means the cancer tissue is similar to normal prostate tissue and the tumour is less likely to spread; a high Gleason score means the cancer tissue is very different from normal prostate tissue and the tumour is more likely to spread

Global market value

The amount a product or service is worth in a global market

Gynaecological cancer

Cancer of the female reproductive tract, including the cervix, endometrium, fallopian tubes, ovaries, uterus and vagina

Harvest

Process for recovering captured cells from the separation system to enable imaging and 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

HER2 (or ERBB2)

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. The protein has become an important biomarker and target of therapy for breast cancer patients

Heterogeneity

A word that signifies diversity

Histopathology

The study of diseased cells and tissues using a microscope

HNV

Healthy normal volunteer

HT29

Cultured colorectal cancer cell line

Immune checkpoint inhibitors (ICI)

A type of immunotherapy that blocks immune checkpoints – key regulators of the immune system. See PD-L1/PD-1

Immune system

A complex network of cells, tissues and organs that help the body fight infections and disease

Immunofluorescence

A technique used to determine the location of an antigen or antibody labelled with a fluorescent dye

Immunohistochemistry

A laboratory test that uses antibodies to test for certain antigens (markers) in a sample of tissue. Immunohistochemistry is used to help diagnose diseases, such as cancer. It may also be used to help tell the difference between different types of cancer

Immunostain

A general term that applies to any use of an antibody-based method to detect a specific protein or antigen in a sample

Immunotherapy

Treatment that stimulates the body’s immune system to fight cancer

In vitro diagnostic (IVD)

An in vitro diagnostic is a method of performing a diagnostic test outside a living body in an artificial environment, usually a laboratory

In-cassette labelling or in-situ labelling

CTC labelling for cell identification undertaken inside the separation system

Indolent cancer

A type of low-risk cancer that grows slowly

Inhibitor

An agent that slows down or interferes with a process or activity

Installed base

Number of units installed and being used by customers, KOLs and the Company

Invasive procedure

A medical procedure that invades (enters) the body, usually by cutting or puncturing the skin

ISO 13485:2016

An international standard that outlines the requirement for a Quality Management System for any company which is involved in the design, production, installation, servicing and manufacturing of medical devices

ISO 15189:2022

An international standard for medical laboratories. Laboratory accreditation helps laboratories develop quality management systems, assesses their competence and ensures they are functioning in line with industry and legal standards

Key Opinion Leader

Key opinion leaders (KOLs) are research centres and/or physicians who influence their peers’ medical practice

KRAS

A signalling molecule frequently mutated in the development of many cancers

Laboratory developed test (LDT)

A laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory 

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 minimally invasive and repeatable

Localised

Describes disease that is limited to a certain part of the body. For example, localised cancer is usually found only in the tissue or organ where it began and has not spread to nearby lymph nodes or to other parts of the body. Some localised cancers can be completely removed by surgery

Longitudinal

Repeat sampling or observations at different points in time

Lymphocyte

A type of immune cell that is made in the bone marrow and is found in the blood and in lymph tissue. A lymphocyte is a type of white blood cell

Lysis

The breaking down of a cell, often by viral, enzymatic, or osmotic mechanisms that compromise its integrity

Malignant

Malignant, otherwise known as cancerous cells form part of the tumour, and can invade and destroy nearby tissue and spread to other parts of the body

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

Mass spectrometry

A tool for measuring the mass-to-charge ratio of one of more molecules present in a sample

MBC

Metastatic breast cancer

MedTech

MedTech, or Medical Technology, is a broad discipline. It is defined as a field that accounts for technologies i.e. devices to the healthcare systems for diagnosis, patient care, treatment and improvement of a person’s health

meEGFR

Arginine methylation of the epidermal growth factor receptor

Megakaryocyte

A large bone marrow cell with a lobulated nucleus responsible for the production of blood thrombocytes (platelets), which are necessary for normal blood clotting

Mesenchymal CTCs

CTCs generally lacking epithelial markers with mesenchymal features

Metastasis

Spread of a cancer from one site to another

Microarray

A microarray is a laboratory tool used to detect the expression of thousands of genes at the same time

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

Micrometastases

Small numbers of cancer cells that have spread from the primary tumour to other parts of the body and are too few to be picked up in a standard actionable biomarker screening or diagnostic test

Microtentacles

Microtubule-based membrane protusions in detached cancer cells

Molecular analysis

Analysis of DNA, RNA and protein often used to determine the mutational status of a patient

Molecular evolution

The study of evolutionary change at a molecular level

Monoclonal antibody

Antibody clones made in a laboratory used to stimulate the immune system

Morphology

The study of the form and structure of cells

Mouse model

The use of special strains of mice to study a human disease or condition, and how to prevent and treat it

MRI

Magnetic resonance imaging, a form of diagnostic imaging that uses strong magnetic fields as well as radio waves

mRNA

Messenger RNA used to direct the synthesis of proteins

MTOR

Mammalian target of rapamycin is a signalling molecule which regulates many key intracellular pathways including cell proliferation, growth and survival. Abnormal activation of MTOR is linked to tumour development and cancer

Multi-omics

The combined analysis of single-cell data which can include analysis of the genome, transcriptome and proteome

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

Next Generation Sequencing (NGS)

Also known as high-throughput sequencing, is the catch-all term used to describe a number of different modern sequencing technologies. It is a method by which the bases of DNA and RNA can be determined, which is used in biological research and to obtain clinically relevant information

NHGRI

The National Human Genome Research Institute

NICE

National Institute for Health and Care Excellence

NIH

National Institute of Health

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 minimally invasive as they do not require surgery

NSCLC

Non-Small Cell Lung Cancer

Nuclear marker

A marker sued to identify the nucleus of a cell

Off-chip labelling

CTC labelling for cell identification of harvested cells undertaken outside the separation system

Omics Revolution

The genomic, transcriptomic, and proteomic analysis of a tumour utilising multiple analytes and techniques to provide a complete picture of a patient’s tumour

Oncologist

A doctor who has special training in diagnosing and treating cancer and may also specialise in certain cancers or techniques

Oncology

A branch of medicine that specialises in the diagnosis and treatment of cancer. It includes medical oncology (the use of chemotherapy, hormone therapy and other drugs to treat cancer), radiation oncology (the use of radiation therapy to treat cancer) and surgical oncology (the use of surgery and other procedures to treat cancer)

Paired samples

Two related samples often used to compare different systems

PARP

Poly (ADP- ribose) polymerase. An enzyme involved in many functions of the cell including the repair of DNA

Parsortix^® PC1 System

The name of the FDA cleared Parsortix system developed and used by ANGLE to capture and harvest metastatic breast cancer CTCs for subsequent, user validated analyses, comprising the automated instrument to run blood samples through the microfluidic cassette and all the associated operating procedures and protocols

Parsortix^® system

The name of the core technologies developed and used by ANGLE to capture and harvest CTCs comprising the automated instrument to run blood samples through the microfluidic cassette and all the associated operating procedures and protocols

Pathologist

A doctor who has special training in identifying diseases by studying cells and tissues under a microscope

Patient care pathway

Refers to the management and care a patient experiences from diagnosis, through treatment, monitoring, residual disease detection and/or remission of their disease

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

PCR

See Polymerase Chain Reaction

PD-1

Programmed Death 1 Receptor. A receptor for PD-L1, a key component in programmed death signalling

PD-L1

Programmed death-ligand 1 (PD-L1) is the principal ligand of programmed death 1 (PD-1), a coinhibitory receptor that can be constitutively expressed or induced in myeloid, lymphoid, normal epithelial cells and in cancer

Peer-reviewed publications

A publication that contains original articles that have been written by scientists and evaluated for technical and scientific quality and correctness by other experts in the same field

Pelvic mass

A general term for any growth or tumour on the ovary or in the pelvis. A pelvic mass can be cystic (cystadenoma), solid (fibroma) or both (dermoid). A pelvic mass can be benign or malignant

Peripheral blood

Blood circulating throughout the body

Personalised cancer care

Treating a patient individually based on their personal data often including mutational and disease status

Pharma

Pharmaceutical companies collectively as a sector of industry 

Pharmacodynamics

The study of the biochemical, physiologic and molecular effects of a drug on the body

Phenotype

A phenotype is the composite of an organism’s observable characteristics or traits, such as its morphology, development, biochemical or physiological properties, behaviour and products of behaviour. A phenotype results from the expression of an organism’s genes as well as the influence of environmental factors and the interactions between the two

PIK3CA

A gene that makes one of the proteins in an enzyme called PI3K, which is involved in many cell functions

Pilot study

The initial study examining a new method or treatment

pKAP1

Phospho-KAP1. A protein involved in response to DNA damage

Plasma

Pale-yellow liquid component of blood obtained following removal of cells

Polymerase Chain Reaction (PCR)

A laboratory technique used to amplify DNA sequences. The method involves using short DNA sequences called primers to select the portion of the genome to be amplified. The temperature of the sample is repeatedly raised and lowered to help a DNA replication enzyme copy the target DNA sequence. The technique can produce a billion copies of the target sequence in just a few hours

Portrait+®

ANGLEs proprietary imaging assay providing pharma services and clinicians with a sample-to-answer solution

Pre-labelled cell lines

Cells which are labelled often with a fluorescent label to facilitate identification during analysis or enrichment

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

Prognosis

The likely outcome or course of a disease; the chance of recovery or recurrence

Prostate-Specific Antigen (PSA)

A protein made by the prostate gland and found in the blood. PSA blood levels may be higher than normal in men who have prostate cancer, benign prostatic hyperplasia (BPH), or infection or inflammation of the prostate gland

Protein expression

The way in which proteins are synthesised, modified, and regulated

Proteogenomics

The study of how information about the DNA in a cell or organism relates to the proteins made by that cell or organism. This includes understanding how genes control when proteins get made and what changes occur to proteins after they are made that may switch them on and off. Proteogenomics may help researchers learn more about which proteins are involved in certain diseases, such as cancer, and may also be used to help develop new drugs that block these proteins

Proteome

The complete set of proteins made by an organism. Proteins are made in different amounts and at different times, depending on how they work, when they are needed, and how they interact with other proteins inside cells

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

PSA

See Prostate-Specific Antigen

Purity

The relative absence of extraneous matter in a sample

Q-Submission

The FDA’s Pre-Submission Program which allows medical device and IVD manufacturers to discuss specific aspects of the regulatory process and requirements with FDA experts

Quantitative assay

An assay which gives an accurate and exact numeric measure of the substance being investigated

Radiotherapy

The use of high-energy radiation from x-rays, gamma rays, neutrons, protons and other sources to kill cancer cells and shrink tumours

Real-time analysis

An assessment providing the most up-to-date and accurate representation of the patient’s disease status

Recurrence

Cancer that has recurred, usually after a period of time during which the cancer could not be detected. The cancer may come back to the same place as the original (primary) tumour or to another place in the body

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

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 Only (RUO)

Sales can be made to certain organisations without the need for regulatory authorisation provided they are labelled as Research Use Only (RUO) or Investigational Use Only (IUO) and are not used for the purposes of patient management

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

RNA-Sequencing (RNA-seq)

Also called whole transcriptome shotgun sequencing (WTSS), uses Next Generation Sequencing (NGS) to reveal the presence and quantity of RNA in a biological sample at a given moment in time

Sample-to-answer

Analysis which combines a fully integrated workflow to provide actionable results (answer) following processing of the original sample material

Screening

Checking for disease when there are no symptoms. Since screening may find diseases at an early stage, there may be a better chance of curing the disease

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

Sequencing platforms

Modern technologies used to read and decipher DNA or RNA sequences on a large-scale with high precision

Single cell analysis

Extraction/picking of a single target cell from the harvest for analysis

Solid biopsy

Standard process for surgically excising (cutting out) cells from a solid tumour when that tumour is accessible

Spatiotemporal metastasis monitoring

To monitor the physical spread/growth of cancer metastasis over time

Spatiotemporal monitoring

Referring to the monitoring of metastasis over time

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

Stage

The extent of a cancer in the body. Staging is usually based on the size of the tumour, whether lymph nodes contain cancer and whether the cancer has spread from the original site to other parts of the body

Standard of care

The current treatment that is accepted by medical experts as the most effective treatment of a disease and is widely used by healthcare professionals. Also known as gold standard, best practice, standard medical care and standard therapy

Standard Operating Procedure (SOP)

Written instructions for doing a specific task in a certain way. In clinical trials, Standard Operating Procedures are set up to store records, collect data, screen and enrol subjects and submit Institutional Review Board (IRB) applications and renewals

Subsequent analysis

The downstream assessment (via imaging or molecular analysis) of CTCs

Therapeutics

A branch of medicine that deals with the treatment of disease

Tissue

Tissue is a group of cells that have similar structure and that function together as a unit 

Transcriptome

The transcriptome is the set of all messenger RNA molecules in one cell or a population of cells

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

Treatment resistance

The failure of a disease or disorder to respond positively or significantly to treatment

Triage

The process of determining the priority of patients’ treatments based on the severity of their condition

Triple negative breast cancer

A subtype of breast cancer that refers to the fact that the cancer cells do not have estrogen or progesterone receptors and also do not make (or make too much) of the protein HER2. This cancer type grows and spreads faster than other cancer types and has fewer treatment options

Tumour evolution

Cancer cells acquire genotypic and phenotypic changes over the course of disease as a result of treatment exposure and/or environmental changes

Tumour heterogeneity

Describes the observation that different tumour cells can show distinct morphological and phenotypic profiles, including cellular morphology, gene expression, metabolism, motility, proliferation, and metastatic potential. This phenomenon occurs both between tumours (inter-tumour heterogeneity) and within tumours (intra-tumour 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 tumour markers are made by both normal cells and cancer cells, but they are made in larger amounts by cancer cells. A tumour marker may help to diagnose cancer, plan treatment or determine how well treatment is working or if the patient has relapsed

Examples of tumour markers include CA-125 (in ovarian cancer), CA 15-3 (in breast cancer), CEA (in colon cancer) and PSA (in prostate cancer)

Tumour/Tumor

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 (non-cancerous), or malignant (cancer)

Tumour is the standard English spelling. Tumor is the standard American English spelling

Vimentin

A structural protein that is expressed in mesenchymal cells. Mesenchymal cells can be found in a variety of tissue including connective tissue, bone marrow, adipose tissue, lymphatic tissue, blood vessels, and blood

WBC

White blood cells

Whole exome sequencing (WES)

A genomic technique for sequencing all of the protein-coding regions of genes in a genome (known as the exome). It consists of two steps: the first step is to select only the subset of DNA that encodes proteins. These regions are known as exons – humans have about 180,000 exons, constituting about 1% of the human genome, or approximately 30 million base pairs. The second step is to sequence the exonic DNA using any high-throughput DNA sequencing technology

Whole genome amplification (WGA)

A PCR technique that is used to produce large quantities of DNA from a small amount of starting material. Unlike conventional PCR, WGA is aimed at amplifying the entire genome of an organism rather than a specific region. It can then be sequenced using WGS

Whole Genome Sequencing (WGS)

A method that is used to learn the exact order of all of the building blocks (nucleotides) that make up a person’s genome (complete set of DNA). WGS is used to find changes that may cause diseases, such as cancer

Whole Transcriptome Amplification (WTA)

A method used to amplify the entire transcriptome from RNA isolated from cells or tissues prior to RNA sequencing. RNA sequencing has enabled high-throughput gene expression profiling to provide insight into the functional link between genotype and phenotype. This has enabled profiling of gene expression in cancer

Xenograft

The transplant of an organ, tissue or cells to an individual of another species. A common example used in cancer biology is a mouse model (mouse xenograft)