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David S. Brooks
Digital Health | Life Sciences | Diagnostics | Product & Strategy | Business Leader | Entrepreneur
David S. Brooks is a professional with a significant background in the healthcare and technology sectors, currently serving as Co-Founder at Casandra.AI. His LinkedIn profile indicates that he is based in Mooresville, North Carolina, and has amassed a substantial network of over 6,000 followers and 500+ connections.
In addition to his role at Casandra.AI, Brooks has experience in various leadership positions, including his tenure at NeoGenomics Laboratories. His expertise encompasses areas such as healthcare technology and innovation, reflecting a commitment to advancing the capabilities of medical services through artificial intelligence and data solutions.
Brooks's professional journey highlights his focus on leveraging technology to improve healthcare outcomes, making him a notable figure in the intersection of these fields.1
Highlights
Having spent countless hours working through the FDA's List of Cleared or Approved Companion Diagnostic Devices in developing https://cdxtests.com, Casandra.AI created the attached list to help visualize approved companion diagnostics (CDx) in a way that I believe is easier to understand, particularly within a clinical context.
This information reflects a few important points:
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A CDx should more accurately be viewed as the combination of Indication-Biomarker-Biomarker Details-Drug/Therapy than an actual assay/panel. In the early days, in a 1 test:1 drug model, that made more sense. Today, particular with comprehensive genetic profiles (CGP) (Foundation Medicine's FoundationOne CDx, TSO500, Guardant Health's Guardant360 CDx, and Tempus AI's xT CDx), a "CDx Test" can address more than 1 Indication-Biomarker-Drug instance. For example, FoundationOne CDx currently addresses 54% of all instances shown on the "Know Your Companions" list. [Note: technically these should also incorporate specimen type, but I feel that introduces an unnecessary level of complexity when trying to summarize this data.]
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This table attempts to capture the additional dimension added by tissue-agnostic therapies with a 'Solid Tumor' indication. As a result, the total count of Indication-Biomarker-Drug instances only counts solid tumor indications with existing approvals (24 solid tumor cancer types). As a result, this underestimates the potential "reach" of tissue-agnostic therapies as well as their associated CDx.
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This data is current as of the FDA's 05/01/2024 release. They recently updated the list on 08/21/2024, which only removed two approvals related to Exkivity which has been voluntarily removed from the market (it is shown in bold red on the attached list).
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Through 08/21/204, there has only been a single new approval in 2024 - Labcorp's AAVrh74 antibody assay (nAbCyte Assay) for BEQVEZ. However, less than a week after the FDA's most recent update, the FDA approved Illumina's TruSight Oncology (TSO500) for 2 CDx (one 'Solid Tumor' [NTRK 1/2/3 fusions] and the other potentially a 'Solid Tumor' [RET fusions] but limited to NSCLC for the time being). This will undoubtedly shake up competition in the CGP segment as this is the first approved CGP by an IVD.
For a complete break-down of the companion diagnostic market, check out https://lnkd.in/exDCJ6_n
#WorldCDx kicks off this week in Boston! Should be an exciting event with lots to talk about.
#WorldCBandCDxBoston, #CDx, #diagnostics, #precisionmedicine
Exciting News!
Casandra.AI has just launched CDxTests.com — the most comprehensive directory of FDA-approved companion diagnostics, searchable by both indication and therapy.
Our mission is clear: every doctor should have the power to order the most precise diagnostic test for their patients, seamlessly integrated into any EHR, from any lab, anywhere. No barriers, just better care.
