BiomEdit receives USDA conditional license for first engineered probiotic

The USDA's Center for Veterinary Biologics has granted a conditional license to BiomEdit's CPerf LLV, a live engineered probiotic designed to reduce necrotic enteritis-associated mortality in broiler chickens. This marks the first USDA conditional license for a genetically engineered probiotic in any animal species worldwide, offering a non-antibiotic alternative for a disease estimated to cost the global broiler industry up to $6 billion annually.

The product, Clostridium Perfringens Alpha Toxin and NetB Antibody Fragment, Live Limosilactobacillus Vector (CPerf LLV), uses a live probiotic strain engineered to target toxins produced by Clostridium perfringens, a main driver of the disease. The conditional license was granted based on a demonstration of a reasonable expectation of efficacy. The USDA pathway allows earlier market access while more data are collected for full licensure; efficacy and potency have not yet been fully demonstrated.

BiomEdit CEO Aaron Schacht called the milestone a defining moment. "USDA conditional licensure of CPerf LLV is a defining moment for BiomEdit and for animal health," Schacht said. The license is held by Diamond Animal Health, BiomEdit's contract development and manufacturing partner. The company will continue working toward a full license for the product, which is expected to be branded Optavant upon full approval.

Efficacy and field evaluation

A key efficacy study reviewed by the USDA CVB found CPerf LLV achieved a 48.7% reduction in necrotic enteritis-associated mortality. Mortality was 13.1% in challenged control birds, compared to 6.6% in birds that received the product.

BiomEdit has also pointed to separately published results in the journal npj Biofilms and Microbiomes. That study showed probiotic-delivered nanobodies improved broiler weight gain and feed conversion, outperforming both prophylactic antibiotics and parent probiotic strains. The USDA did not review those published data as part of the conditional licensure process.

The company has launched a commercial evaluation program with three major U.S. poultry producers. CPerf LLV is expected to be deployed in more than 35 million broilers during this evaluation, which lets producers see how it performs in their own systems. Andrew Carlson, BiomEdit's chief commercial officer, noted strong industry interest. "We have been encouraged by the level of interest from poultry producers as we move from regulatory approval into real-world use," Carlson said.

Company context and leadership

BiomEdit, founded in 2022, achieved this conditional licensure in just over four years. The company is backed by investors including Anterra Capital, Viking Global Investors, Nutreco, and Elevate Ventures. BiomEdit has also initiated its Series C financing round; proceeds will fund CPerf LLV's commercial launch, path to full licensure, and other pipeline programs.

In August, the company acquired Folium Science's technology platform and pipeline assets, including its BiomElix® One and Guided Biotics® CRISPR-Cas technology. The announcement of the USDA license was made by BiomEdit in Indianapolis on September 29, 2026.

The product label indicates CPerf LLV has shown a reasonable expectation of efficacy for passive immunity of healthy chicks against Clostridium perfringens. The duration of that passive immunity has not been determined. BiomEdit will continue working toward a full license for CPerf LLV, which is expected to be branded Optavant upon approval.