According to the National Cancer Institute (NCI) it has designated the LuViva(TM) Advanced Cervical Scan by Guided Therapeutics, Inc. as one of the agency's greatest investments success stories. They have given more than $6 million in successive grants to Guided Therapeutics since 2001 to develop this system.
The device has been tested at 10 clinical centers in the United States upon approximately 3,000 women showing positive results. The device is being reviewed by the FDA (Food and Drug Administration). They are expected to make a decision regarding approval next month, in January 2012.
The LuViva Advanced Cervical Scan created by Guided Therapeutics has been working with the NCI (National Cancer Institute) and is designed to scan the cervix for cancer and precancerous lesions and unlike the Pap, provides immediate results painlessly and non-invasively.
An interesting result of the trial was to show that cervical disease was just as likely to occur in women in the age group 16-20 as it was in those over 20. This is in direct contradiction with guidelines currently proposed which would eliminate Pap testing on women under 21 in the United States. LuViva was shown to detect cervical disease two years in advance of the Pap, HPV tests, colposcopy or biopsy.
This will certainly create a contradiction when it comes to cervical cancer screening guidelines now being finalized. Screening guidelines are looking to eliminate testing for women under 21, stating that cancer in this age group is low, but whom according to the LuViva tests, are just as likely to develop cancer as their older counterparts.
Women’s groups may question why the guidelines are attempting to eliminate early diagnosis for women under 21 who are just as deserving of an early diagnosis as older women.
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NCI: SBIR & STTR - Success Story - SBIR Phase II Bridge Award." NCI: SBIR & STTR. N.p., n.d. Web. 12 Dec. 2011. http://sbir.cancer.gov/success/stories/guided_therapeutics/index.asp
Reviewed December 12, 2011
by Michele Blackberg RN
Edited by Jody Smith