Guided Therapeutics Wants Face-to-Face FDA Meeting to Resolve Approval Issues

Guided Therapeutics keeps punching. The Norcross, Ga.-based company, which has stumbled getting its primary technology approved by the U.S. Food and Drug Administration, has submitted a letter requesting a face-to-face meeting with agency officials in the next 60 to 90 days.

The request is a response to a  “not approvable” letter the firm received in September for its LuViva Advanced Cervical Scan. The letter was the second such communication in 18 months, asking more questions about a cervical scanning device the company originally submitted for review in 2010. Guided Therapeutics received its first FDA let-down in January 2012, when the agency questioned LuViva’s clinical data and how the company analyzed it.

In September FDA officials asked new analysis of the device’s clinical data and more information on disinfection of the scanner and its optics, according to the company.

The device, which is designed to detect cervical disease that can lead to cancer, already is approved in Europe and elsewhere. The technology has marketing approvals from Health Canada and the Singapore Health Sciences Authority. The company has filed for approval in Mexico. Additionally, expansion efforts are ongoing in the Middle East, Asia, Africa and Latin America.
Additionally, the FDA has granted the company its requested 180 day extension on the premarket approval application filing to allow time for the meeting to occur.

“While we have drafted our responses to questions in the not approvable letter received in September, we feel it is in our best interest to meet with FDA before submission of the official response,” said Gene Cartwright, CEO of Guided Therapeutics. “These face-to-face meetings are an important part of advancing the approval process. The extension we received on March 18 will enable both the company and FDA to prepare adequately in order to make the most of the meeting.”

“While focusing on growing sales for our product in places like Canada, Turkey, Europe and Africa, we remain confident in the potential of LuViva in the U.S. market and remain committed to pursuing FDA approval,” Cartwright added.

LuViva 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 that, according to the company, “eliminates costly, painful and unnecessary testing.”

LuViva is designed 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. The device is used in conjunction with the LuViva Cervical Guide single-use patient interface and calibration disposable.