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Diagnostics overview
Diagnostics overview
Evolving Terminology for Emerging Technologies
Comments? Questions?
Revisions? Mary Chitty MSLS
mchitty@healthtech.com
Last revised
January 14, 2020
SCOPE NOTE Diagnostics
include biomarkers, cancer diagnostics/liquid biopsy/circulating cell free
DNA/circulating tumor cells, companion diagnostics, pharmacogenomics for
clinical trial patient stratification, prenatal diagnostics/
Related glossaries include
:
Biomarkers
Molecular Diagnostics
Molecular
Medicine Pharmacogenomics
& Personalized Medicine Regulatory
Sequencing
SNPs,
CNVs & other genetic variations
Cancer diagnostics are also in
Cancer and Cancer overview
Next Generation Diagnostics
2020
Aug 25-27, Washington DC coverage
spans cell- and cell-free biopsies, commercialization, reimbursement,
biomarkers and companion diagnostics for immunotherapy, point-of-care
testing, infectious disease, microfluidics and precision medicine. .
https://www.nextgenerationdx.com/
Molecular Medicine TriConference
Precision Health
March 2-4, 2020 San Francisco CA https://www.triconference.com/Precision-Health
key opinion leaders in immunotherapy, liquid biopsy, and cell and gene
therapy will discuss the latest tools, clinical advances, and commercial
applications of a broad range of new and diverse products for vast
improvements in medicine and healthcare.
assay:
A laboratory test to find and measure the
amount of a specific substance. NCI Dictionary of Cancer Terms, National
Cancer Institute
https://www.cancer.gov/publications/dictionaries/cancer-terms?cdrid=44528
investigative (analytic) procedure in laboratory medicine, pharmacology,
environmental biology and molecular biology for qualitatively assessing or
quantitatively measuring the presence, amount, or functional activity of a
target entity (the analyte).
https://en.wikipedia.org/wiki/Assay
biomarker, or biological marker,
generally refers to a measurable indicator of some biological state or
condition. The term is also occasionally used to refer to a substance the
presence of which indicates the existence of a living organism.
https://en.wikipedia.org/wiki/Biomarker
circulating tumor cells CTCs: Circulating
Tumor Cells
and Liquid Biopsy
March 2-4 2020 • San Francisco, CA | The
way we think about cancer is about to change. What we used to treat as a
random occurrence is becoming both predictable and preventable through an
array of emerging circular biomarkers. Through the use of circulating
tumor cells, cell-free circulating DNA, exosomes, exomers, oncosomes and
other extracellular vesicles, we are now able to understand early stages
of cancer and apply molecular profiling to clinical trial selection,
patient treatment and minimal residual disease detection. The applications
are expanding outside of cancer to include transplant medicine,
cardiovascular disease, CNS, autoimmune and infectious disease.
https://www.triconference.com/Circulating-Tumor-Cells
Circulating tumor cells (CTCs)
are cells that have shed into the vasculature or lymphatics[1] from a
primary tumor and are carried around the body in the circulation. CTCs
thus constitute seeds for the subsequent growth of additional tumors
(metastases) in vital distant organs, triggering a mechanism that is
responsible for the vast majority of cancer-related deaths.[2]
https://en.wikipedia.org/wiki/Circulating_tumor_cell
Digital
Health MARCH 2-4, 2020,
San Francisco CA Digital Health is promising to revolutionize
healthcare delivery, optimize personalized and precision medicine, and
offer new tools for drug and diagnostic development. The applications of
biosensors, mobile devices and wearables, Internet of Things, mobile
health platforms, artificial intelligence, and digital biomarkers are
quickly expanding into all areas of patient monitoring and disease
management, point-of-care diagnostics, and digital endpoints in clinical
trials.
https://www.triconference.com/Digital-Health
DNA, or deoxyribonucleic acid,
is the hereditary material in humans and almost all other organisms. DNA
is a double helix formed by base pairs attached to a sugar-phosphate
backbone. An important property of DNA is that it can replicate, or make
copies of itself. Each new cell needs to have an exact copy of the DNA
present in the old cell.
Genetics Home Reference, National Library of Medicine
https://ghr.nlm.nih.gov/primer/basics/dna
immuno-oncology IO Summit: August
10-14 2020 Boston MA As
our understanding of tumor immunology has advanced, immuno-oncology has
made unprecedented progress in improving the outcomes for cancer patients.
Still, with the field in its infancy, the full curative potential of IO
has yet to be realized . https://www.immuno-oncologysummit.com/
in vitro
diagnostics: Commercializing Novel IVDs , Harry Glorikian,
Insight Pharma Reports Executive Summary The
process of developing a successful in vitro diagnostic (IVD) relies on the
expertise of a diverse group of individuals, including the scientists who
identify the biomarkers of significance, engineers and assay developers
who translate those ideas into a tangible product, and the sales and
marketing staff who get the product into the market. Global and regional
trends have a tremendous effect on the IVD industry. Rising healthcare
costs have led to a greater emphasis on evidence-based medicine and a
focus on improved patient outcomes. An aging population along with the
growing epidemic of chronic diseases and (re)emergence of infectious
diseases are creating a demand for diagnostic devices for a variety of
conditions. The growth of emerging economies and the push for
decentralized healthcare are opening the IVD market to a wider audience.
Healthcare delivery systems are changing, with growing numbers of
integrated delivery networks and accountable care organizations, while
smaller physician and hospital networks are being acquired by larger
corporations and/or are aligning themselves with other small groups.
https://www.insightpharmareports.com/commercializing-novel-ivds-a-comprehensive-manual-for-success
Laboratory Developed Tests LDTs:
a type of in vitro diagnostic test that is designed, manufactured
and used within a single laboratory. ... For example, some tests can
detect many DNA variations from a single blood sample, which can be used
to help diagnose a genetic disease. FDA, LDTs
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/LaboratoryDevelopedTests/default.htm
liquid biopsy
This is an unprecedented time in biomolecular medicine. 1) Recent
scientific findings have determined biofluids consist of circulating tumor
cells (CTCs), cell-free nucleic acid (cfNA), or extracellular vesicles
from multiple tissues within the body. 2) Rapid development of highly
sensitive and accurate next-generation sequencing (NGS) technologies has
allowed analysis of the role of these biomolecules, and has been rapidly
adopted into molecular diagnostic laboratories. And 3) researchers are
empowered to analyze the role of these biomolecules in health, disease and
treatment response leading to targeted therapies. However, there still
remains insecurity associated with biofluid-based DNA/RNA analytical
methods, which must be solved before liquid biopsies can be implemented
for broader routine applications.
June 15-17, 2020 Seattle WA
https://www.liquidbiopsysummit.com/
Molecular Diagnostics Europe
2020 May 19-21 Lisbon Portugal
https://www.dxinnovationsummit.com/ Now Diagnostics Innovation
Summit
Molecular Diagnostics for Infectious
Disease March 2-4, 2020
San Francisco, CA | Advancing
Molecular Diagnostics to Improve Detection and Patient Outcome With NGS
assays moving into clinical use and new technologies being developed for a
host of infectious diseases, it is more important than ever to keep on top
of the latest advances in the field. Cambridge Healthtech Institute’s 4th
Annual Molecular Diagnostics for Infectious Disease symposium will discuss
in detail the process of moving sequencing into clinical use, with an
examination of reference vs. clinical labs, metagenomics vs. panel-based
tests, investments in bioinformatics, and physician education. We will
also examine rapid susceptibility testing in the light of the new
breakpoints, how they are used, and the role genotypic vs. phenotypic
testing. Special attention will also be paid to new technologies for host
response and clinical applications of microbiome analysis. We will also
have a discussion centered around the regulatory landscape for NGS
diagnostics and what to expect as we will look into the future of
molecular diagnostics for infectious disease.
https://www.triconference.com/Molecular-Diagnostics-for-Infectious-Disease
molecular diagnostics non-invasive: See
liquid biopsy, prenatal diagnostic testing
Molecular Medicine TriConference
Precision Health
March 2-4, 2020 San Francisco CA https://www.triconference.com/Precision-Health
key opinion leaders in immunotherapy, liquid biopsy, and cell and gene
therapy will discuss the latest tools, clinical advances, and commercial
applications of a broad range of new and diverse products for vast
improvements in medicine and healthcare.
Next Generation
Diagnostics
2020
Aug 25-27, Washington DC coverage
spans cell- and cell-free biopsies, commercialization, reimbursement,
biomarkers and companion diagnostics for immunotherapy, point-of-care
testing, infectious disease, microfluidics and precision medicine. .
https://www.nextgenerationdx.com/
Point of Care Technologies
August 26-27, 2020 Washington, DC
|
Point-of-care technologies (POCT) provide actionable information at the
location and time of care. This can mean by the hospital bedside, on the
battlefield, or even at home versus conventional laboratory-based testing.
This requires diagnostic testing to be done in a way where sample
preparation is automated, the assay or sensor is accurate with a simple
read out, having the whole platform should be easy to bring to locations
outside of a laboratory or a hospital, and the cost to manufacture should
be low. Some POC tests can utilize a smart phone or other mobile device to
provide data analysis and is useful for sending data to the cloud.
Creating an accurate, sensitive, reliable diagnostics that anyone can use
is difficult, and there are many challenges to overcome.
https://www.nextgenerationdx.com/microfluidics/
screening: Carrying
out of a test or tests, examination(s) or procedure(s) in order to expose
undetected abnormalities, unrecognized (incipient) diseases, or defects:
examples are mass X-rays and cervical smears. IUPAC
Toxicology
Not the same as screening
in the sense of Assays
stratification: Early
patient stratification is critical to enable effective and personalized
drug discovery and development. See
also Pharmacogenomics
Diagnostics Resources
Diagnostics & biomarkers Conferences http://www.healthtech.com/conferences/upcoming.aspx?s=BMK
Molecular
Medicine Tri Conference Precision Health
https://www.triconference.com/precision-health Next Generation Diagnostics https://www.nextgenerationdx.com/
How
to look for other unfamiliar terms
IUPAC definitions are reprinted with the permission of the International
Union of Pure and Applied Chemistry.
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