New European Published Study Shows LuViva Detects 20% More Precancerous and Cancerous Cervical Disease than HPV Test

Rhea-AI Summary

Guided Therapeutics, Inc. (OTCQB: GTHP) announced impressive results from an independent study of its LuViva Advanced Cervical Scan. The study with 166 women in Hungary showed LuViva detected 20% more cervical precancer and cancer than the HPV test, boasting a sensitivity of 94%. LuViva also provides immediate results without the need for extensive lab infrastructure. The device has received CE Mark and is set for launch in Central and Eastern Europe this year. The Hungarian medical community sees LuViva as a significant improvement in cervical screening quality.

Positive

• LuViva detected 20% more cervical precancer and cancer than HPV tests.
• Sensitivity of LuViva was reported at 94%, detecting 48 of 51 cases.
• Immediate results are provided by LuViva, enhancing patient care.
• LuViva received CE Mark and plans for launch in Central and Eastern Europe.

Negative

• None.

Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, based on its patented biophotonic technology, announced today that an independent study of 166 women in Hungary showed that LuViva detected 20% more cervical precancer and cancer than the HPV test. Specifically, LuViva had a very high sensitivity of 94%, 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% for LuViva and 81% 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%) and HPV (37%). 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, Prof. 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.

About Guided Therapeutics

Guided Therapeutics, Inc. (OTCQB: GTHP) is the maker of 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. For more information, visit: www.guidedinc.com.

The Guided Therapeutics LuViva^® Advanced Cervical Scan is an investigational device and is limited by federal law to investigational use in the U.S. LuViva, the wave logo and "Early detection, better outcomes" are registered trademarks owned by Guided Therapeutics, Inc.

Forward-Looking Statements Disclaimer: A number of the matters and subject areas discussed in this news release that are not historical or current facts deal with potential future circumstances and developments. The discussion of such matters and subject areas is qualified by the inherent risks and uncertainties surrounding future expectations generally and also may materially differ from Guided Therapeutics’ actual future experience involving any of or more of such matters and subject areas. Such risks and uncertainties include those related to the early stage of commercialization of products, the uncertainty of market acceptance of products, the uncertainty of development or effectiveness of distribution channels, the intense competition in the medical device industry, the sufficiency of capital raised in prior financings and the ability to realize their expected benefits, the uncertainty of future capital to develop products or continue as a going concern, the uncertainty of regulatory approval of products, and the dependence on licensed intellectual property, as well as those that are more fully described from time to time under the heading “Risk Factors” in Guided Therapeutics’ reports filed with the SEC, including Guided Therapeutics’ Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and subsequent filings.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210728005101/en/

FAQ

What were the results of the LuViva study conducted in Hungary?

The study revealed that LuViva detected 20% more cervical precancer and cancer compared to the HPV test, with a sensitivity of 94%.

What is the sensitivity of the LuViva test?

The sensitivity of the LuViva test is reported at 94%, successfully detecting 48 out of 51 cases of precancer or cancer.

When will LuViva be launched in Europe?

LuViva is set to launch this year in Central and Eastern Europe and next year in Russia.

How does LuViva compare to HPV testing in terms of results?

LuViva provides immediate results and detected 20% more cases of cervical disease than HPV testing, which requires lab processing.

What is the significance of the LuViva's CE Mark?

The CE Mark indicates that LuViva meets European health, safety, and environmental protection standards, allowing it to be marketed in Europe.