On Target Laboratories and Mauna Kea Technologies Demonstrate Intraprocedural Targeted Detection of Lung Cancer with a Molecular Imaging Agent

Study published in Nature Communications finds cancer-targeted molecular imaging agent with needle-based confocal laser endomicroscopy system achieved rapid, highly sensitive and specific detection of cancer cells during biopsy procedures, with excellent diagnostic accuracy and reproducibility

On Target Laboratories, Inc. and Mauna Kea Technologies today announced publication of a study entitled “Targeted Detection of Cancer at the Cellular Level During Biopsy by Near-Infrared Confocal Laser Endomicroscopy”¹ in the peer-reviewed scientific journal Nature Communications.

The proof-of-concept study, conducted at University of Pennsylvania School of Medicine in Philadelphia, evaluated the use of On Target’s intraoperative molecular imaging agent, CYTALUX™ (pafolacianine) injection, paired with Mauna Kea’s U.S. FDA 510(k) cleared Cellvizio® platform for intralesional visualization of cells that have taken been up by CYTALUX™ during biopsy of pulmonary nodules.

A Molecular Image-guided Procedure (MIP) conducted with near-infrared needle-based confocal laser endomicroscopy (NIR-nCLE) may allow for real-time detection of cancer in smaller, difficult to visualize lung nodules with improved diagnostic yield during pulmonary nodule biopsy, all during a minimally invasive bronchoscopy.

The study demonstrated this new approach can identify small volumes of cancer, including a single cancer cell among one thousand normal cells, in a type of pulmonary nodule known as a ground glass opacity (GGO), which is particularly challenging to identify and diagnose with existing technology. Furthermore, the study showed that NIR-nCLE can deliver easily interpretable images in real time which allow the user to accurately distinguish between cancerous and non-cancerous tissue during bronchoscopic biopsy, with an overall sensitivity and specificity of 100% and 92%, respectively, and very high inter- and intra-observer agreements.

“This study marks an important milestone in the development of needle-based confocal laser endomicroscopy for its application in lung cancer. In assessing the use of Cellvizio with CYTALUX, we’ve demonstrated the potential for the first ever real-time endoluminal molecular imaging technology for lung cancer,” stated Nicolas Bouvier, interim CEO of Mauna Kea Technologies. “These results signal that Molecular Image-guided Procedures conducted with near-infrared needle-based confocal laser endomicroscopy have the potential to be a must-have in the bronchoscopy suite.”

“We are thrilled about the results of this study,” said Chris Barys, Chief Executive Officer of On Target Laboratories. “We look forward to continuing our collaboration with Mauna Kea and working towards extending our intraoperative molecular imaging agents to more patients.”