LuViva Advanced Cervical Scan image courtesy of Guided Therapeutics Inc.
August 20, 2015 — Guided Therapeutics Inc. announced that it has presented the U.S. Food and Drug Administration (FDA) with a plan for advancing the pre-market approval (PMA) application for the LuViva Advanced Cervical Scan. In its “pre-submission” letter, the company also requested a meeting with the agency to finalize the plan.
LuViva is a technologically advanced diagnostic device that scans the cervix with light and uses spectroscopy to measure how light interacts with the cervical tissue. Spectroscopy identifies chemical and structural indicators of pre-cancer that may be below the surface of the cervix or misdiagnosed as benign. This technique is called biophotonics. Unlike Pap, HPV tests or biopsies, LuViva does not require laboratory analysis or a tissue sample, and is designed to provide results immediately, which may result in eliminating costly, painful and unnecessary additional testing.
LuViva is intended for use with women who have undergone initial screening and are called back for follow up with a colposcopy examination, which in many cases, involves taking a biopsy of the cervix. It has also been used in clinical studies in Turkey and Nigeria as a means to screen women for cervical cancer where the availability of infrastructure necessary for Pap and HPV testing is restricted. The device is used in conjunction with the LuViva Cervical Guide single-use patient interface and calibration disposable.
At the suggestion of the FDA, the company plans to collect additional scans on patients within the context of new cervical cancer screening guidelines recently published by the American Cancer Society, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology. The letter provides a proposal for a confirmatory study to supplement data previously provided to the agency. In the meeting, the company hopes to gain agreement from the FDA on the study design.
The company currently has regulatory approval to sell LuViva in Europe with the Edition 3 CE mark, and has marketing approvals from COFEPRIS in Mexico, Health Canada and the Singapore Health Sciences Authority, among others. Additionally, expansion efforts are ongoing in the Middle East, Asia and Latin America.
For more information: www.guidedinc.com