-
-
Caveat is that it can only handle up to V2 chemistry. -
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.ilmnComment
-
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
Tweet
-
Genomics studies in neuroscience face a special challenge due to the brain’s complexity and scarcity of samples. Mapping changes in cell type and state using conventional next-generation sequencing methods remains challenging. Advances in technologies like single-cell sequencing, spatial transcriptomics, and long-read sequencing have opened the door to deeper studies of the brain and diseases like Alzheimer’s, amyotrophic lateral sclerosis (ALS), and schizophrenia.
...07-09-2026, 11:10 AM -
Cancer survival rates have significantly increased in the last few decades in the United States, reaching a combined 70% 5-year survival rate by 2021. Behind this number, there are years of research to find new therapies, drug targets, and early detection methods. But there is one core challenge that keeps slowing down these advances, and it’s about drug resistance.
There is no single reason why many patients don’t respond to treatment as expected. Cancer is...07-08-2026, 05:17 AM -
Love this - good data definitely starts from good input, and poor input can only give relatively poor data. I particularly like the mention of Nanodrop/absorbance based methods for quantification. It's such a toss up if you'll get an accurate reading or what amounts to a randomly generated number, and a lot of library/sequencing related issues can be traced back to poor quant.07-01-2026, 11:43 AM
Comment