Guided Therapeutics' shares soaring ahead of pending FDA decision Print E-mail
By M.E.Garza   
Sunday, 11 December 2011 04:46
FDA CalendarShares of Guided Therapeutics (OTC:GTHP) rose as high as $1.52 and closed 22% higher 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.

Non-Invasive Device for Cervical Cancer Detection: Guided Therapeutics (OTC:GTHP)

NCI awarded Guided Therapeutics more than $6 million since 2001 to develop LuViva

A day earlier on Thursday, shares of GTHP also saw double-digit 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.

Shares traded nearly seven times the daily average volume and closed at the three-year resistance levels. If the stock breaks past those resistance levels, it could see another effusive run, particularly if the firm recives news from U.S. regulators early. Strong positive news would likely impact the firm's moderately priced ($70M) market cap, especially given the increasingly tigher float. Only 13K of the total outstanding shares (roughly 49 million) are currently short the stock.

As biotech specuilators know, the valuations of these medical device diagnostics companies usually increase significantly after an FDA approval and acquisition by leaders in the space who can combine, market and accelerate the development of new integrated tools for diagnosis under their own umbrella becomes far more likely.

“We are honored that LuViva has been acknowledged as a successful investment by the world’s leading cancer research organization,” said CEO and president Mark L. Faupel, Ph.D., yesterday. “This recognition underscores LuViva’s unique approach for improving the standard of care in cervical disease detection. The NCI is a valuable partner in the development of LuViva, and the collaborative support of the agency makes innovation like ours possible.”

LuViva™ identifies cancers and precancers quickly by analyzing light reflected from the cervix. The device creates an image of the cervix for the doctor that highlights the location and severity of disease. More than 1,600 women at risk for cervical disease were tested with the LuViva™ in a multi-center pivotal clinical trial. Results of the trial showed that:

  •     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.

Disclosure: None

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