Editor: What To Know
- According to the clinical studies included in the CE Mark application and reviewed by the CE authorities, LuViva can now be used as an alternative to traditional screening methods, especially in localities or countries where cervical cancer screening programs are unavailable or underutilized because of a lack of laboratory infrastructure or other limitations.
- The screening indication for use is in addition to LuViva's previous indication for use as a secondary screener for assessing the risk of cervical disease in women who screen positive on traditional screening tests such as the Pap smear.
- In addition to the CE Mark, the new ISO certification is an important milestone, as it is becoming the de facto quality system standard around the world, including for the U.
LuViva Advanced Cervical Span: Guided Therapeutics, Inc. maker of a rapid and painless testing platform based on its patented biophotonic technology, announced that its flagship product, the LuViva Advanced Cervical Scan, had received a new CE Mark through its European contract manufacturer, Newmars Technologies, Kft. (Budapest, Hungary). As a part of this process, Newmars Technologies’ quality system passed the new, more rigorous ISO 13485:2016 standard for medical devices.
In addition to the CE Mark, the new ISO certification is an important milestone, as it is becoming the de facto quality system standard around the world, including for the U.S. FDA.
We are extremely pleased to have been able to work with Newmars Technologies in completing this major milestone. The CE Mark enables expanded commercialization of LuViva Advanced Cervical Span in 27 EU-associated countries totaling a population of 229 million women. It also is the accepted standard used by many other countries around the world,” said Gene Cartwright, Guided Therapeutics CEO.
The new CE Mark for the LuViva Advanced Cervical Span includes expanded claims for the use of LuViva by physicians for the early detection of cervical cancer. According to the clinical studies included in the CE Mark application and reviewed by the CE authorities, LuViva can now be used as an alternative to traditional screening methods, especially in localities or countries where cervical cancer screening programs are unavailable or underutilized because of a lack of laboratory infrastructure or other limitations. LuViva has previously been approved for cervical cancer screening in countries as diverse as Indonesia, Kenya, and Costa Rica. The screening indication for use is in addition to LuViva’s previous indication for use as a secondary screener for assessing the risk of cervical disease in women who screen positive on traditional screening tests such as the Pap smear. As opposed to the Pap smear and Human Papilloma Virus test, LuViva does not require a laboratory infrastructure for processing a sample and produces an immediate result at the point of care, so that treatment can begin sooner.
“Achieving the CE Mark with expanded claims for screening will be a significant boost in our efforts to market LuViva in the Central and Eastern European countries we plan to launch in this year,” said Karoly Majoros, CEO of Newmars Technologies. “We look forward to working with Guided Therapeutics to bring enhanced detection of cervical cancer at its earliest stages when it is most treatable.”
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.
