Technology

FDA Greenlights New AI Virus Treatment For Trial, Company Says

FDA photo by Michael J. Ermarth

Officials at an artificial intelligence research company shared that the Food and Drug Administration approved experimental trials to treat patients with AI-created viruses.

AI start-up Radical Numerics posted a technical report on Tuesday indicating they are utilizing its research to not only design specialized bacterium viruses with AI but also use them to treat patients, with the goal of taking the process mainstream. The FDA approved this methodology and authorized the trials, company officials told the New York Times the same day.

The FDA did not provide the DCNF with comment on the record in time for publication. Radical Numerics did not respond to the DCNF’s request for comment.

Founded in 2025, Radical Numerics is the home and laboratory for Omnii — a genome language AI model focused on building general biological intelligence. Instead of working with computer code, Omnii works across molecular landscapes including DNA, RNA, proteins and cellular systems, according to the company’s website.

A team of researchers for Radical Numerics personalized and administered the AI designed virus, modeled after a naturally occurring virus called a “phage,” to a patient suffering from a deadly bacterial infection, the Times reported.

Phages are found in all microbial ecosystems including oceans, soil, and the human gut microbiome, the report from Radical Numerics said, calling the phage “bacteria’s natural enemy.” By personalizing phage viruses to match an individual’s bacteria infection, the company developed a treatment “therapy,” to solve and combat illness.

The report posted on the company’s website has not been peer reviewed and the company declined to provide information about the specifics of the trial to the New York Times, including about the patient undergoing the procedure or the doctors carrying it out.

“We take our responsibility to protect patient confidentiality and maintain the trust of our clinical partners extremely seriously,” Eric Nguyen, the chief executive officer of Radical Numerics told the Times. “We intend to publish our scientific findings through peer-reviewed research, with any future disclosure of clinical details subject to appropriate consent.”

“The idea behind phage therapy is deceptively simple: find phages that can kill the bacteria causing a patient’s infection and administer them as a treatment,” the report said, saying that phages do not infect human cells and the AI-created therapy is “generally considered safe.”

The company also uses Omnii to develop biodefense mechanisms, evaluate pandemic risks, and has a history of designing personalized mRNA vaccines reportedly to treat cancer, the company’s about page notes.