The FDA has informed Guided Therapeutics that it expects to rule by January 20, 2012 on its application for pre-market approval. Guided Therapeutics are makers of the LuViva device which can painlessly detect precancerous and cancerous lesions resulting from the human papillomavirus, providing immediate results and making more invasive procedures unnecessary.
Since information relating to this device was released late last year, it has already been approved for use in Canada, and the company has also entered into an agreement for utilizing the device in the U.K. as well.
Eurosurgical Limited is partnering with Guided Therapeutics in the U.K. to utilize LuViva as a follow-up to a positive Pap smear. In the U.S., the next step after a positive Pap smear would be a colposcopy with possible biopsy.
The use of the LuViva device would preclude the need for invasive biopsies while providing on-the-spot results. This is certainly a positive outcome especially for patients who will not have to wait days or weeks for biopsy results.
In typical fashion, the U.S. lags behind other parts of the world like Europe and Canada when it comes to approval on such issues.
This was the case regarding the use of the HPV vaccine in males as well as recommending, as opposed to simply approving, use of the vaccine for boys and young males. Canada has approved the HPV vaccine up to the age of 45 for women, which the U.S. has declined to do.
For a country which is supposed to be waging a “war on cancer” the agencies in the U.S. responsible for approval of devices, vaccines and other therapeutic medications obviously have not gotten the message.
Mark L. Faupel. "National Cancer Institute Designates Guided Therapeutics’ LuViva™ Advanced Cervical Scan an Investment Success Story - Bloomberg." Bloomberg - Business & Financial News, Breaking News Headlines. N.p., n.d. Web. 18 Jan. 2012.
Wire, Business. "Guided Therapeutics Selects Eurosurgical Ltd To Distribute LuViva™ Advanced Cervical Scan In The United Kingdom - TheStreet." Stock Market Today - Financial News, Quotes and Analysis - TheStreet. N.p., n.d. Web. 18 Jan. 2012.
"Guided Therapeutics' LuViva approved by Health Canada - Yahoo! Finance." Yahoo! Finance - Business Finance, Stock Market, Quotes, News. N.p., n.d. Web. 18 Jan. 2012.
6th, Ed Silverman // April, and 2011. " FDA Rejects Gardasil For Use In Most Adult Women // Pharmalot ." Pharmalot // Pharma Blog . N.p., n.d. Web. 18 Jan. 2012. http://www.pharmalot.com/2011/04/fda-rejects-gardasil-for-use-in-most-adult-women/
Reviewed January 18, 2012
by Michele Blacksberg RN
Edited by Jody Smith