Glossary

Glossary

Alzheimer’s Disease (AD)
Alzheimer’s Disease is a dementing illness characterized by progressive neuronal degeneration, glial cell scarring, and the accumulation of intracellular neurofibrillary tangles and extracellular amyloid (senile) plaques in discrete brain regions governing memory, attention, language, visuospatial abilities, and executive functions.

ART
Assisted reproductive techniques/technologies (IVF is an ART procedure)

ASRM
American Society of Reproductive Medicine, US-based professional society primarily of MDs but also Ph.D. scientists

Bioinformatics
Sophisticated mathematical formulations that are constructed to extract, integrate and correlate multi-parametric data that can then be used to create and evaluate predictive mathematical models. Bioinformatics is an essential tool for mining the vast amounts of data produced by metabolomic analysis.

Biomarkers
A broad term that includes any chemical, protein, genetic, small molecule or anatomical entity that can be measured and correlated to normal or pathophysiological conditions.

Biospectroscopy
An optical-based analytical technology (e.g., nuclear magnetic resonance (NMR, mass spectroscopy (MS), Raman or NIR spectroscopy) that provides a simultaneous and integrated measure of all metabolic activities taking place in a biological sample or field (fluids or cells) and then uses the resulting spectral data to create a profile of molecular biomarkers. Each profile translates into a unique “fingerprint” or “signature” that defines the metabolic status of the target sample and thus the biological host whence the sample was procured.

Clinical development plan
The prospective organization of a series of human clinical studies that provide data to achieve FDA approval

CRF
Case report form, official document to collect clinical trial data

D3
Third day of embryo culture in the lab

D5
Fifth day of embryo culture in the lab

ERP
Embryo Reproductive Potential

ESHRE
European Society of Human Reproduction and Embryology. The EEC counterpart to ASRM

IC
Informed consent, used with IRB for all patients in a clinical study

IDE
Investigational device exemption, FDA process for medical device products

Idiopathic Parkinson disease (PD)
Idiopathic Parkinson disease (PD) is a movement disorder characterized by progressive degeneration of dopaminergic neurons in the substantia nigra pars compacta, formation of a-synuclein-containing fibrillar inclusions (Lewy bodies) within this cell population, and depletion of various other monoaminergic neurons elsewhere in the neuraxis. Resting tremor, rigidity, hypokinesia and postural instability are the cardinal symptoms of this common neurodegenerative disorder.

IETS
International Embryo Transfer Society, the international equivalent of ESHRE and ASRM but much more basic science oriented. Broader focus to include animal and veterinary applications

IRB
Investigational review board, approves human clinical trial programs

IVD
In vitro diagnostics, a review section with FDA

IVF “cycle”
The complete medical treatment process of IVF that mimics the natural menstrual cycle except it is highly augmented by technology and fertility hormone drugs

MET
Multiple embryo transfer

Metabolomics
A form of systems biology that provides a biochemical “snapshot” of the small molecule inventory produced during cellular metabolism and, thus, reflects the physiological status of an organism. It is the most recent “omic” in scientific research. Alternatively, metabolomics has been defined as “the quantitative measurement of the multi-parametric metabolic response of living systems to pathophysiological stimuli, or genetic modifications”.

Metabolomic Profile (MetPro)
Represents a “snapshot” of ongoing biological processes that are defined by the presence and distribution of unique small molecule biomarkers and metabolites. The presence of certain biomarkers, or groups of metabolites, and their dynamic ratios, can be used as an indication of the presence or predisposition to disease.

Mild Cognitive Impairment (MCI)
The term MCI is applied to elderly individuals who experience gradual cognitive decline of at least six months duration that fails to meet strict clinical criteria for AD or other dementia. Approximately 50% of MCI subjects will progress to probable AD over an ensuing 3-5 year period.

N =
Number (typically refers to number of subjects in a study)

NIR
Near infrared, a form of spectroscopy

NMR
Nuclear magnetic resonance, a form of spectroscopy

OS
Oxidative stress, a condition that occurs when there is an excess of free radicals, a decrease in antioxidant levels, or both

Pivotal trial
The decisive trial on which the FDA decides to approve or disapprove a product; based on safety and efficacy

PMA
Pre-marketing approval, a class III medical device

POC
Proof of concept

Raman
A form of spectroscopy

SET
Single embryo transfer

Spectrum
a unique of pattern of light scattering or absorbance across a range of wavelength