Functional Diagnostics in North Carolina

Owlstone Medical is a UK-based biotechnology company pioneering breath biomarker analysis for non-invasive disease detection and precision medicine. The company develops Breath Biopsy® technology and related research products and services that enable comprehensive analysis of volatile organic compounds (VOCs) from multiple sample types, ranging from in vitro cell culture to human breath samples. Clinical applications span oncology (lung cancer, multi-cancer early detection), respiratory disease (cystic fibrosis, Pseudomonas aeruginosa detection), gastrointestinal disorders, liver disease, and microbiome analysis. Owlstone's Breath Biopsy VOC Atlas® is a proprietary database of volatile organic compound biomarkers supporting research and clinical validation. The company collaborates with major academic medical centers (Mayo Clinic, Cleveland Clinic, Brigham and Women's Hospital, NHS), pharmaceutical partners (AstraZeneca, Boehringer Ingelheim, MedImmune), and cancer research organizations (Cancer Research UK). Recent funding includes a $49.1 million ARPA-H award for developing at-home multi-cancer early detection tests targeting Stage I detection of 30+ solid tumors, and a Cystic Fibrosis Foundation investment for breath testing of bacterial infections. Owlstone maintains an active FDA research collaboration agreement for developing analytical methods to identify specific chemicals in gaseous mixtures. The company is positioned in the diagnostic software and decision-support space, providing tools for biomarker identification and clinical validation rather than manufacturing traditional medical devices.

Lucerno Dynamics develops, manufactures, and markets the Lara® System, a passive skin sensor platform designed to detect and quantify radiolabeled biomarkers during nuclear medicine procedures. The system identifies radiopharmaceutical extravasations in seconds, evaluates injection impact within minutes, and reduces error frequency over time. Lara provides real-time quality control and assurance for nuclear medicine administrations, supporting patient-specific dosimetry and therapy response monitoring in solid tumors. With over 28,000 monitored administrations, Lucerno addresses a significant clinical gap: approximately 4.5 million extravasations annually occur in U.S. nuclear medicine procedures, with 500,000+ classified as significant. The system requires minimal patient experience impact (20 seconds added) and technologist workflow disruption (1 minute), making it practical for high-volume clinical settings seeking to enhance safety and procedural confidence.