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Old 11-24-2013, 08:41 AM   #4
Location: Bay area

Join Date: Jun 2012
Posts: 76

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.
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