Abbreviations Flashcards
(29 cards)
IDN
Integrated Delivery Network
LDT
Laboratory Developed Test - does not need FDA approval, only CLIA safety approval
CLIA
Clinical Laboratory Improvement Amendment - Issued by CMS to ensure safety standards are met to protect patients from invalid lab results
GCLP
Good Clinical Laboratory Practice - Needed alongside CLIA for clinical trial approval (SOAR)
TAM
Total Addressable Market - Revenue opportunity available for a product or service
Fair Market Value
Deciding how to trade for services between buyer-seller (Ex: BSW giving us data in exchange for the product for free)
Competitor
Grail - Galleri
Sensitivity
Test’s ability to designate an individual with a diseases as POSITIVE (the positive rate)
Specificity
Probability of a negative test provided one does not have the condition (True Negative Rate)
RWE
Real World Evidence - Register with OM1. BSW will integrate with OM1 to provide us with RWE for FMV
Beta Testing
an opportunity for real users to use a product in a production environment to uncover any bugs or issues before a general release. Beta testing is the final round of testing before releasing a product to a wide audience.
KOLs
Key Opinion Leaders
5 Biomarkers
Protein biomarkers Mutations (short variants) Anueploidy Fragmentation Methylation
PRE
Builds Product
accessing identifiers (wet and dry lab)
II
Classifier
for FDA
IDE
Investigational Device Exemption - Needed by CMS for FDA Trials
Service stack
everything with the assay
HL7
Secure way of transmitting patient data - but can only be transmitted once
LIMS
Laboratory Information Management System - end to end for the lab - connecting this tube to this person/demographics
OM1
Vendor that helps us obtain data from partners
PAC
Product approval committee - formalized process for product develolment
Market access
Who we are selling to and requirements needed to implement
PMA submission
Needed for premarket approval
OUS
Outside US
