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?
Seqanswers Leaderboard Ad
Collapse
Announcement
Collapse
No announcement yet.
X
-
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.
Leave a comment:
-
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
Leave a comment:
-
NGS devices get US-FDA approval
Latest Articles
Collapse
-
by seqadmin
Like all molecular biology applications, next-generation sequencing (NGS) workflows require diligent quality control (QC) measures to ensure accurate and reproducible results. Proper QC begins at nucleic acid extraction and continues all the way through to data analysis. This article outlines the key QC steps in an NGS workflow, along with the commonly used tools and techniques.
Nucleic Acid Quality Control
Preparing for NGS starts with isolating the...-
Channel: Articles
02-10-2025, 01:58 PM -
-
by seqadmin
In recent years, precision medicine has become a major focus for researchers and healthcare professionals. This approach offers personalized treatment and wellness plans by utilizing insights from each person's unique biology and lifestyle to deliver more effective care. Its advancement relies on innovative technologies that enable a deeper understanding of individual variability. In a joint documentary with our colleagues at Biocompare, we examined the foundational principles of precision...-
Channel: Articles
01-27-2025, 07:46 AM -
ad_right_rmr
Collapse
News
Collapse
Topics | Statistics | Last Post | ||
---|---|---|---|---|
Genetic Mapping of Plasmodium knowlesi Identifies Essential Genes and Drug Resistance Mechanisms
by seqadmin
Started by seqadmin, 02-07-2025, 09:30 AM
|
0 responses
67 views
0 likes
|
Last Post
by seqadmin
02-07-2025, 09:30 AM
|
||
Started by seqadmin, 02-05-2025, 10:34 AM
|
0 responses
104 views
0 likes
|
Last Post
by seqadmin
02-05-2025, 10:34 AM
|
||
Started by seqadmin, 02-03-2025, 09:07 AM
|
0 responses
83 views
0 likes
|
Last Post
by seqadmin
02-03-2025, 09:07 AM
|
||
Started by seqadmin, 01-31-2025, 08:31 AM
|
0 responses
45 views
0 likes
|
Last Post
by seqadmin
01-31-2025, 08:31 AM
|
Leave a comment: