Despite being selected by the National Cancer Institute as one of the most successful investments for developing innovative products to fight cancer, the FDA, as anticipated by this author, denied approval of the LuViva device on Friday January 20, 2012, the anticipated date for its decision.
LuViva is used following positive Pap smear results to determine the presence or absence of precancerous or cancerous lesions of the cervix without the invasive biopsy necessary during a colposcopy.
Results are provided immediately thus reducing patient anxiety waiting for biopsy results and is reported to be painless in its application.
Canada had already approved LuViva for use in December of 2011 and it is expected to be in use by the second half of 2012 in countries in Europe.
Guided Therapeutics Inc. now plans to seek an independent panel review, something the FDA had indicated would not be necessary.
"We are disappointed that the FDA has issued a not-approvable letter after previously telling the company that a panel review of LuViva would not be necessary since the agency understood LuViva’s technology, it understood the clinical application and had also reviewed similar devices in the past,” said Mark L. Faupel, Ph.D., president and CEO of Guided Therapeutics.
Apparently the FDA gives little credence to the recommendations made by the National Cancer Institute and has chosen, yet again, to delay the availability of this device for American women, thus forcing them to endure more invasive and painful procedures in the interim.
"Guided Therapeutics Provides Update on PMA Application for LuViva® Advanced Cervical Scan and Timing for Filing of CE Mark | Business Wire." Press Release Distribution, Financial Disclosure, Online Newsrooms, PR, Public Relations, Investor Relations, EDGAR filing, XBRL, Breaking News, Business News, Financial News | Business Wire. N.p., n.d. Web. 22 Jan. 2012.
" Guided Therapeutics Denied Approval For LuViva Scan; Seeks Panel Review .