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Svetlana Nikic: Comprehensive and structured list of FDA-approved CDx NGS assays. Super easy to be found at FDA’s website
Apr 21, 2024, 23:34

Svetlana Nikic: Comprehensive and structured list of FDA-approved CDx NGS assays. Super easy to be found at FDA’s website

Svetlana Nikic, Founder of Precision Oncology Consulting, shared a post on LinkedIn:

“With an overwhelming amount of data coming to our inboxes and social media, sometimes I struggle to find relatively simple but important information such as a comprehensive and structured list of FDA-approved CDx NGS assays.

Well it’s actually super easy to be found at FDA’s website.

Bear in mind, this list has been updated last time on Dec ’23.

Here are some interesting facts:

– There is 154 FDA-cleared/approved CDx claims for solid tumors
– Of these, 74 are based on NGS-assays (19 for LBx) and are produced by 8 manufacturers
– FMI is leading the way with 43 claims, followed by Life Tech (12)
– Nr of claims per cancer type: NSCLC (34), BC (9), CRC (7), OC (5), Pan-Cancer (6), Cholangiocarcinoma (2), MTC (2), Melanoma (2), mCRPC (4), mCRC, ATC, pancreatic, prostate and TC (1 each)

As said it is easy to find but I am also more than happy to email it to you – just send me a separate message.

And let me know if this was useful! ”

Read further.
Source: Svetlana Nikic/LinkedIn


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