05.14.14
Guided Therapeutics Inc. is moving ahead with a new submission to the U.S. Food and Drug Association (FDA) for its primary technology.
After what company officials called a “productive” discussion with regulators, they plan to submit an amendment to the pre-market approval application for the LuViva Advanced Cervical Scan.
The filing will include responses to questions raised in the agency’s not-approvable letter from September last year.
“The purpose of the meeting was to present the agency with our proposed answers to questions raised by FDA in the September letter and to help clarify our final responses,” said Gene Cartwright, CEO of Norcross, Ga.-based Guided Therapeutics. “The meeting was constructive and we were able to put forward our logic and arguments and engage in a detailed discussion with the FDA. We will incorporate our responses and FDA feedback into our formal response, which we plan to file within the next 45 days.”
Once submitted, the FDA will have 180 days to respond to the company’s submission. Additional dialogue with FDA is expected as the company moves toward approval.
Guided Therapeutics has regulatory approval to sell LuViva in Europe with the CE mark, and has marketing approvals from Health Canada and Singapore Health Sciences Authority and has filed for approval in Mexico.
LuViva is a 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 other common tests, LuViva does not require laboratory analysis or a tissue sample, and is designed to provide results immediately, which 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.
According to company officials, their technology was able—in a multi-center clinical trial with women at risk for cervical disease—to detect cervical cancer up to two years earlier than conventional modalities. Guided Therapeutics is also developing a non-invasive test for the early detection of esophageal cancer using the same technology platform.
After what company officials called a “productive” discussion with regulators, they plan to submit an amendment to the pre-market approval application for the LuViva Advanced Cervical Scan.
The filing will include responses to questions raised in the agency’s not-approvable letter from September last year.
“The purpose of the meeting was to present the agency with our proposed answers to questions raised by FDA in the September letter and to help clarify our final responses,” said Gene Cartwright, CEO of Norcross, Ga.-based Guided Therapeutics. “The meeting was constructive and we were able to put forward our logic and arguments and engage in a detailed discussion with the FDA. We will incorporate our responses and FDA feedback into our formal response, which we plan to file within the next 45 days.”
Once submitted, the FDA will have 180 days to respond to the company’s submission. Additional dialogue with FDA is expected as the company moves toward approval.
Guided Therapeutics has regulatory approval to sell LuViva in Europe with the CE mark, and has marketing approvals from Health Canada and Singapore Health Sciences Authority and has filed for approval in Mexico.
LuViva is a 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 other common tests, LuViva does not require laboratory analysis or a tissue sample, and is designed to provide results immediately, which 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.
According to company officials, their technology was able—in a multi-center clinical trial with women at risk for cervical disease—to detect cervical cancer up to two years earlier than conventional modalities. Guided Therapeutics is also developing a non-invasive test for the early detection of esophageal cancer using the same technology platform.