LuViva Still Not There with FDA, Beefs Up International Effort

A month ago, Guided Therapeutics issued a press release confirming that it had not yet satisfied the FDA that its LuViva® Advanced Cervical Scanning technology should be granted its PMA. A month later the company has announced a beefing up of its international distribution efforts with new territories to include France, Qatar, Malaysia, Indonesia and Bangladesh. Combined, these territories include approximately 86 million women aged 25 to 64 years.


Guided Therapeutics, Inc. is the maker of a rapid and painless testing platform based on its patented biophotonic technology that utilizes light for the early detection of disease at the cellular level. Specifically, diagnostic device 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 precancer that may be below the surface of the cervix or misdiagnosed as benign. This technique is called biophotonics and is an alternative to the Electrical Impedance Spectroscopy technology used by Zilico with its Zedscan device, covered by us a week or so ago, here.

In common with Zedscan, 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. The device is used in conjunction with the LuViva® Cervical Guide single-use patient interface and calibration disposable.

Of note, neither LuViva nor Zedscan yet have FDA approval. Guided Therapeutics has been keeping its investors up to date with LuViva proceedings for a while now, and although clearly sounding disappointed not to be over the finishing line in teh United States, has repeatedly stated the importance of the international markets, which it has said offer the greater opportunity for LuViva and a faster path to profitability.

Company comments

“We continue to see high levels of interest for LuViva across the globe as governments and other institutions work to reduce the financial burden of managing cervical cancer,” said Mark L. Faupel, president and CEO of Guided Therapeutics. “The regulatory environment in international markets has been particularly receptive to new technology. Developed countries are beginning to adopt human papillomavirus (HPV) testing to screen for cervical cancer which is creating a high number of false positive results leading to women receiving unnecessary, invasive testing. LuViva is uniquely suited to effectively help manage this population. As a result, the international market remains a potentially lucrative opportunity for building shareholder value over the near term.”

Source: Guided Therapeutics, Inc.