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Re: satter post# 5418

Sunday, 11/16/2025 8:20:13 PM

Sunday, November 16, 2025 8:20:13 PM

Post# of 7342
🔥🔥KRAKEN NEWS🔥🔥
US Patent No. 11,817,214 is titled "Machine Learning Model Trained to Determine a Biochemical State and/or Medical Condition Using DNA Epigenetic Data." The patent covers a diagnostic method using artificial intelligence and epigenetic biomarkers, not a drug or medical device that requires full FDA premarket approval for general use.
Here is a breakdown of its status:
Patent Scope: The patent covers a method and apparatus related to using DNA data and machine learning for health and longevity insights, derived from a saliva sample. It is owned by the epigenetics subsidiary of FOXO, a company that integrates epigenetic biomarkers into its products.
FDA and Patents: The FDA does not "approve" patents. The U.S. Patent and Trademark Office (USPTO) issues patents, while the FDA regulates the products (drugs, devices, biologicals) that may be covered by a patent.
Regulatory Status: The technology described is a diagnostic tool or service. Such products often fall under different regulatory pathways (e.g., laboratory developed tests or device clearance/approval, depending on how they are marketed). The provided search results do not indicate that the specific product or service utilizing this patent has undergone a formal FDA approval process (like a New Drug Application (NDA) or Premarket Approval (PMA)).
FDA "Approval": The term "FDA approval" typically refers to the rigorous process for new drugs and high-risk medical devices, which is distinct from the type of services described by this patent (which seem to be consumer-oriented health/longevity insights).
For information on whether a specific drug is FDA-approved, you can use the Drugs@FDA database or the FDA Orange Book. The technology described in this patent is not a drug listed in those databases.
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