Seqanswers Leaderboard Ad
Collapse
Announcement
Collapse
No announcement yet.
X
-
Not surprising. There will likely be no "user serviceable parts" in MiSeqDX. Approval is for specific version of MCS/chemistry/analysis software.
This application may need a new purchase i.e. an existing MiSeq probably can't be upgraded to a MiSeqDX.
Looks like the pages for Molecular Diagnostics are already up: http://www.illumina.com/clinical/diagnostics.ilmn
Comment
-
In fact, the instrument would be a "downgrade" compared to what is out now from what I understand...the requirement of the FDA approval process that everything must be locked down prior to submission.
But, while this does open the door to FDA-approved reagents for NGS, there could be ramifications for current LDTs using sequencing given the CLIA vs. FDA ambiguity.
Comment
-
I presume if you want to make a product out of this MiSeqDX, your interpretation software should also need FDA approval, right?
Are there any incentive for Foundation Medicine or OncoType DX to create an FDA-approved version of their test? It seems to me they can just keep marketing them as LDTs forever?
Comment
Latest Articles
Collapse
-
by seqadmin
Despite advancements in sequencing platforms and related sample preparation technologies, certain sample types continue to present significant challenges that can compromise sequencing results. Pedro Echave, Senior Manager of the Global Business Segment at Revvity, explained that the success of a sequencing experiment ultimately depends on the amount and integrity of the nucleic acid template (RNA or DNA) obtained from a sample. “The better the quality of the nucleic acid isolated...-
Channel: Articles
03-22-2024, 06:39 AM -
-
by seqadmin
The field of conservation genomics centers on applying genomics technologies in support of conservation efforts and the preservation of biodiversity. This article features interviews with two researchers who showcase their innovative work and highlight the current state and future of conservation genomics.
Avian Conservation
Matthew DeSaix, a recent doctoral graduate from Kristen Ruegg’s lab at The University of Colorado, shared that most of his research...-
Channel: Articles
03-08-2024, 10:41 AM -
ad_right_rmr
Collapse
News
Collapse
Topics | Statistics | Last Post | ||
---|---|---|---|---|
Started by seqadmin, Yesterday, 06:37 PM
|
0 responses
8 views
0 likes
|
Last Post
by seqadmin
Yesterday, 06:37 PM
|
||
Started by seqadmin, Yesterday, 06:07 PM
|
0 responses
8 views
0 likes
|
Last Post
by seqadmin
Yesterday, 06:07 PM
|
||
Started by seqadmin, 03-22-2024, 10:03 AM
|
0 responses
49 views
0 likes
|
Last Post
by seqadmin
03-22-2024, 10:03 AM
|
||
Started by seqadmin, 03-21-2024, 07:32 AM
|
0 responses
67 views
0 likes
|
Last Post
by seqadmin
03-21-2024, 07:32 AM
|
Comment