Guided Therapeutics' shares soar ahead of pending FDA decision

Shares of Guided Therapeutics GTHP rose as high as $1.52 and closed 22% higher at $1.43 on Friday after we reported to our premium subscribers that the firm is awaiting a key approval decision from the FDA in regards to their LuViva™ Advanced Cervical Scan technology device.

A day earlier on Thursday, shares of GTHP also saw double growth and closed at $1.17 after news that the National Cancer Institute (NCI) had designated the firm's LuViva™  as one of the agency’s successful investments for developing innovative products to fight cancer, but we are hearing credible chatter that the company may be getting some good news in regards to their pending FDA decision.

For those of you not familiar with the company, Guided Therapeutics developed Biophotonics technology that is used in medicine to study tissue and blood at the macro (large-scale) and micro (very small scale) organism level to detect, diagnose and treat diseases in a way that are non-invasive to the body. Its LuViva™ Advanced Cervical Scan uses light to detect chemical and structural changes in cervical tissue. The technology being developed for the cancer product is called hyperspectral imaging spectroscopy or HIS. HIS acquires the individual spectrum of each cell component while it is in the body. The device then identifies physiological markers of cancer based on their spectral signatures.

LuViva is currently under U.S. Food and Drug Administration (FDA) premarket application review and our BioMedReports FDA Calendar shows that the FDA has informed Guided Therapeutics that the agency expects to rule on the application by January 20, 2012, but a decision could come much sooner according to our sources.

•     LuViva™ detected cervical disease up to two years earlier than Pap test, HPV test, colposcopy and biopsy.
•     LuViva™ detected 86.3% cervical disease cases that had been missed by Pap, HPV (human papillomavirus) tests and biopsy.
•     LuViva™ would have reduced the number of unnecessary biopsies by about 40 percent.

Additionally, the clinical trials indicated that women aged 16-20 were just as likely to have cervical disease as women 21 and older and current methods of early detection, such as HPV testing, are not recommended for this age group. LuViva detected cervical disease equally well in both adolescent and adult women.

In August the firm announced that it began human testing of its light-based detection technology for Barrett’s Esophagus, a precursor for esophageal cancer. That technology is being jointly developed with Konica Minolta Opto of Japan.