PEACHTREE CORNERS, Ga., June 2026
Guided Therapeutics, Inc. announced the submission of its Premarket Approval (PMA) clinical report to the U.S. Food and Drug Administration (FDA) for the LuViva® Advanced Cervical Scan, a non-invasive diagnostic platform designed to improve the detection of cervical disease and precancerous lesions. The submission includes results from a multicenter clinical trial evaluating LuViva’s performance in women referred for biopsy following abnormal Pap smear and/or HPV test results. The study findings demonstrated that LuViva significantly enhanced disease detection beyond the current standard of care, highlighting its potential to improve cervical cancer screening and early intervention strategies.
Clinical Trial Demonstrates Significant Improvement in Disease Detection
The FDA-reviewed study enrolled 480 women, with 428 participants completing the trial. Independent pathology experts identified 99 women with significant cervical disease, including precancerous conditions that could progress to cervical cancer if left untreated. Among these cases, 32 lesions were missed by conventional colposcopy-directed biopsy, representing more than 32% of disease cases. LuViva successfully detected 21 of these 32 missed lesions, identifying approximately 66% of cases overlooked by standard diagnostic procedures. As a result, the overall disease detection rate increased from 68% using conventional methods alone to 89% when LuViva was incorporated into the diagnostic workflow. The study achieved all primary and secondary endpoints related to sensitivity and specificity with a high level of statistical significance, reinforcing the technology’s diagnostic performance.
Biophotonic Technology Enables Non-Invasive Cervical Assessment
The LuViva Advanced Cervical Scan utilizes patented biophotonic technology that analyzes tissue characteristics through light-based assessment at the cellular level. Unlike traditional diagnostic methods that often require invasive procedures and tissue sampling, LuViva provides a rapid, painless, and non-invasive examination at the point of care. The technology is designed to identify abnormal cervical tissue instantly, enabling healthcare providers to obtain valuable diagnostic information during patient visits. By detecting subtle cellular changes associated with precancerous disease, LuViva has the potential to complement existing screening methods and reduce the risk of missed diagnoses that could delay treatment and disease management.
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FDA Review Marks Important Step Toward Commercial Advancement
Guided Therapeutics stated that no device-related safety concerns or adverse events were reported during the clinical study, supporting the platform’s favorable safety profile. Company leadership noted that the trial results exceeded expectations and demonstrated the technology’s ability to address a critical unmet need in cervical disease detection. The PMA submission represents a major regulatory milestone for the company as it seeks FDA approval for broader clinical adoption of the LuViva system. If authorized, the technology could provide clinicians with an additional tool to improve cervical cancer prevention by identifying high-risk lesions earlier than conventional approaches. The company also plans to pursue publication of the study findings in a leading peer-reviewed medical journal, further contributing to the growing body of evidence supporting advanced optical diagnostic technologies in women’s healthcare.
Source: Guided Therapeutics press release
