ROSE Diagnostics Achieves Key Milestone with First Patient Enrolled in Clinical Study

Carlsbad, CA - December 5th 2024

ROSE Diagnostics Inc. is excited to announce the enrollment of the first patient and successful collection of initial samples in its first clinical study. This marks a critical step forward in verifi™ LUNG Test's development, setting the stage for its clinical validation and future deployment.

Currently, up to 40 percent of lung biopsy samples are inadequate and require a follow-up procedure to obtain another sample. The verifi LUNG Test allows physicians to quickly test biopsy samples in the operating room to ensure they are viable for analysis before being sent to the lab. Ultimately, this technology will reduce time to diagnosis, allowing lung cancer patients to get treatment sooner, which reduces the risk of mortality.

The study aims to collect lung biopsy specimens from up to 100 patients in order to characterize this novel sample type and to optimize the final verifi LUNG Test system.

The study will integrate fresh specimens from Coastal Pulmonary Associates Scripps Health Network (Encinitas, CA) and frozen samples from the Firestone Institute for Respiratory Health (Hamilton, Canada). The study’s principal investigators, Dr. Samir Makani of Scripps and Dr. Eldar Priel of Firestone, bring significant expertise to this critical initiative.

The clinical study, which began on November 27, 2024 at the Firestone Institute, will additionally provide critical insights to guide the final stages of product development and clinical validation for the verifi LUNG Test System.  Building on these findings, ROSE Diagnostics plans to initiate two additional clinical performance studies in 2025: a pilot clinical study in Q1, followed by the pivotal study.

ROSE Diagnostics continues its commitment to revolutionizing cancer diagnostics by bridging the gap between pathology labs and clinics and improving patient outcomes.

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For further inquiries, please contact: info@rose-dx.com