Summary: Invenio Imaging has begun enrolling patients in a U.S. study to test its AI-based module for lung cancer detection, aiming to develop the first FDA-cleared AI for identifying suspicious tissue in lung biopsies.

Key Takeaways

  1. Invenio Imaging has started enrolling patients for a U.S. study to assess its AI-based image analysis module for detecting lung cancer during bronchoscopic biopsies.
  2. The ON-SITE study, in collaboration with Johnson & Johnson and major medical centers, aims to develop the first FDA-cleared AI for identifying suspicious cell/tissue morphology in lung biopsies.
  3. The NIO Laser Imaging System allows rapid, in-room imaging of fresh tissue without staining, aiding in cancer detection when ROSE is not available.

————————————————————————————————————————————————————

Invenio Imaging announced the start of patient enrollment in a U.S. pivotal study of its AI-based image analysis module for lung cancer. The ON-SITE study, a multicenter trial combining stimulated Raman histology with artificial intelligence for lung cancer detection, is in collaboration with Johnson & Johnson Enterprise Innovation Inc. and will be conducted at several centers, including The University of Texas MD Anderson Cancer Center in Houston, Corewell Health in Grand Rapids, Mich., Memorial Sloan Kettering Cancer Center in New York, and the University of North Carolina (UNC) at Chapel Hill.

Tackling Lung Biopsy Challenges

Invenio is developing an FDA-cleared AI to identify cell/tissue morphology suspicious for cancer in lung biopsies. Lung cancer remains the leading cause of cancer-related deaths in the United States, leading to large-scale screening programs for high-risk patients. These programs identify an estimated 3.1 million new primary lung nodules each year. Despite advances in biopsy technology, obtaining adequate tissue for biomarker and treatment determination remains challenging. Bronchoscopy guidelines recommend rapid-on-site tissue evaluation (ROSE) for lung biopsies.

“ROSE requires that a cytologist or highly trained cytotechnician be physically present in the procedure room, and thus it is not available at many centers performing lung biopsy due to resource limitations,” says Jason Akulian, MD, director of interventional pulmonology at UNC. “We are excited by the NIO’s potential to extend the benefits of ROSE to the proceduralist when the service is not available.”

The NIO Laser Imaging System enables rapid imaging of fresh tissue biopsies in the treatment room without requiring staining or sectioning and can be performed by the existing OR staff. NIO Slides are designed to allow retrieval of the sample for downstream analysis. NIO® images are digital and can be shared in near real-time. The ON-SITE study aims to develop and validate an AI-based image analysis module for the NIO® Laser Imaging System to assist physicians in detecting cancer in bronchoscopic lung biopsies when ROSE is unavailable.

AI in Healthcare

“Artificial intelligence aiding healthcare may seem utopic, but the future is coming. While still investigational, the promise of fast, in-room, accurate identification of tissue that is suspicious for cancer has the potential to ultimately lead to improved outcomes, a beneficial cost/benefit profile, and personalized treatments,” says Gustavo Cumbo-Nacheli, MD, a pulmonologist at Corewell Health and one of the site PIs for the ON-SITE study.

“Enrolling the first patient in the ON-SITE study is an important milestone for Invenio, as we aim to develop the first FDA-cleared AI to identify cell/tissue morphology suspicious for cancer in lung biopsies,” adds Jay Trautman, PhD, co-founder and CEO of Invenio Imaging. “Near real-time image analysis on the NIO Laser Imaging System completes the end-to-end solution for streamlined intraoperative histology.”