Clinical OMICs - Volume 3, Issue 9 - 17
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The first document, entitled "Use of Public Human clinical validity. Offering another interesting insight, FDA
Genetic Variant Databases to Support Clinical Validity for notes that there "are several parallels" between guidelines
[NGS]-Based In Vitro Diagnostics" is seemingly narrow. for variant curation and FDA review of clinical validity. To
It addresses the ability of NGS applicants to rely upon the extent that the draft guidance shows greater recepcurated databases in lieu of providing clinical validity data. tiveness to reliable third party sources, there would be a
The use of external data to demonstrate
welcome spillover effect.
clinical validity is critical to the viabilHowever, while FDA has unlocked the
The
use
of
external
data
to
ity of submitting applications to FDA
door to the use of curated databases,
for NGS IVDs. Generating its own data
pushing the door open will not be easy.
demonstrate clinical validity
to prove the clinical validity of a single
FDA is not proposing that any and every
is critical to the viability of
biomarker or genetic sequence can be
database may be cited. Rather, an applisubmitting applications
challenging for a company. Trying to do
cant can only use databases that pass
to FDA for NGS IVDs.
that for a wide range of variants would
FDA muster, and that will not be easy.
be daunting in the extreme, and would
Obtaining FDA recognition of a datadeter or prevent applications. FDA has opened the possi- base will take work. For example, the database operator
bility of NGS applicants referencing a database rather than must not only be transparent, but must provide enough
generating its own data.
information about data sources and SOPs to allow third
The implications of this approach go beyond NGS. There parties "to make fully informed medical decisions." Variant
are other situations in which IVD manufacturers want to use data should be accompanied by metadata. The database
external information to show the clinical validity of mark- operator will need to make its decision matrices publicly
(continued on next page)
ers. A recurring issue for IVD companies is demonstrating
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17
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Table of Contents for the Digital Edition of Clinical OMICs - Volume 3, Issue 9
Contents
Clinical OMICs - Volume 3, Issue 9 - Cover1
Clinical OMICs - Volume 3, Issue 9 - Cover2
Clinical OMICs - Volume 3, Issue 9 - Contents
Clinical OMICs - Volume 3, Issue 9 - 4
Clinical OMICs - Volume 3, Issue 9 - 5
Clinical OMICs - Volume 3, Issue 9 - 6
Clinical OMICs - Volume 3, Issue 9 - 7
Clinical OMICs - Volume 3, Issue 9 - 8
Clinical OMICs - Volume 3, Issue 9 - 9
Clinical OMICs - Volume 3, Issue 9 - 10
Clinical OMICs - Volume 3, Issue 9 - 11
Clinical OMICs - Volume 3, Issue 9 - 12
Clinical OMICs - Volume 3, Issue 9 - 13
Clinical OMICs - Volume 3, Issue 9 - 14
Clinical OMICs - Volume 3, Issue 9 - 15
Clinical OMICs - Volume 3, Issue 9 - 16
Clinical OMICs - Volume 3, Issue 9 - 17
Clinical OMICs - Volume 3, Issue 9 - 18
Clinical OMICs - Volume 3, Issue 9 - 19
Clinical OMICs - Volume 3, Issue 9 - 20
Clinical OMICs - Volume 3, Issue 9 - 21
Clinical OMICs - Volume 3, Issue 9 - 22
Clinical OMICs - Volume 3, Issue 9 - 23
Clinical OMICs - Volume 3, Issue 9 - 24
Clinical OMICs - Volume 3, Issue 9 - 25
Clinical OMICs - Volume 3, Issue 9 - 26
Clinical OMICs - Volume 3, Issue 9 - 27
Clinical OMICs - Volume 3, Issue 9 - 28
Clinical OMICs - Volume 3, Issue 9 - 29
Clinical OMICs - Volume 3, Issue 9 - 30
Clinical OMICs - Volume 3, Issue 9 - 31
Clinical OMICs - Volume 3, Issue 9 - 32
Clinical OMICs - Volume 3, Issue 9 - 33
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