Study: LuViva Detects More Cervical Disease Cancers Than HPV Test

Guided Therapeutics Inc., maker of the LuViva Advanced Cervical Scan, based on its patented biophotonic technology, is touting an independent study of 166 Hungarian women that showed LuViva detected 20 percent more cervical precancer and cancer than an HPV test.

Specifically, LuViva had a very high sensitivity of 94 percent, detecting disease in 48 of 51 women with biopsy results of precancer or cancer, compared with 40 detected by HPV for the same group of 51 women. In addition, the confidence that a negative LuViva result truly indicated no significant disease (negative predictive value) was 90 percent for LuViva and 81 percent for HPV. The confidence that a positive test result truly indicated presence of disease (positive predictive value) was about the same for both LuViva (35 percent) and HPV (37 percent). According to new U.S. guidelines, women with this high a likelihood of cervical disease or higher need to either have tissue removed for a definitive diagnosis or consider immediate treatment.

In contrast to HPV testing, LuViva does not require a costly and time-consuming lab infrastructure and provides results immediately as opposed to the delay of several days for lab tests such as the Pap or HPV. The study was conducted by a team led by Prof. Dr. Zoltan Hernadi at the Department of Obstetrics and Gynecology at the University of Debrecen, Hungary.
 
As published in the Hungarian medical journal Orvosi Hetilap, Hernadi and his team concluded that the LuViva test “is another opportunity to improve the quality of our Hungarian cervical screening system. Highlights of the test are high sensitivity and negative predictive value.” LuViva has earned the CE Mark and is working with its European manufacturing and distribution partner Newmars Technologies to launch the product this year in Central and Eastern Europe and next year in Russia.
 
According to the World Health Organization, cervical cancer is ranked as the fourth most common type of cancer in women worldwide, with approximately 700,000 cases reported annually. Because cervical cancer often is detected too late, it is one of the leading causes of cancer-related female death in developing countries, with 311,000 women lost each year.
 
Guided Therapeutics Inc. makes a rapid and painless testing platform based on its patented biophotonic technology that utilizes light for the early detection of disease at the cellular level. The company’s first product is the LuViva Advanced Cervical Scan, a non-invasive device used to detect cervical disease instantly and at the point of care. In a multi-center clinical trial with women at risk for cervical disease, the technology was able to detect cervical cancer up to two years earlier than conventional modalities, according to published reports. 
 
The Guided Therapeutics LuViva Advanced Cervical Scan is an investigational device and is limited by federal law to investigational use in the United States.