Guided Therapeutics Passes Required Compliance Testing for Clinical Trials

Guided Therapeutics Inc., maker of the LuViva Advanced Cervical Scan, based on its patented biophotonic technology, announced its Chinese co-manufacturing partner and distributor for China, Shandong Yaohua Medical Instrument Corporation (SMI), has received notice from the Jinan Medical Device Quality Supervision and Testing Center of the State Food and Drug Administration that LuViva has passed safety and electromagnetic compliance requirements necessary to be used in clinical trials.

SMI estimates that Chinese Food and Drug Administration (FDA) approval and initial sales in China will occur in the second half of 2022. SMI reports that it has signed sub-distributor contracts for three provinces in expectation of Chinese FDA approval next year.
 
“Passing compliance testing certified by the Chinese State Food and Drug Administration is a major milestone for us,” said Gene Cartwright, CEO of Guided Therapeutics. “We expect progress in China to accelerate based on this milestone, which allows the start of the clinical study in China.”
 
According to the World Health Organization, cervical cancer is ranked as one of the most frequent cancers in women in the world, and in China it is the second most common cancer among women. China has a population of approximately 560 million women above 15 years of age, who are at risk of developing cervical cancer. Current estimates indicate approximately 100,000 new cases of cervical cancer are diagnosed each year, and 30,000 deaths occur annually due to cervical cancer in China.
 
Guided Therapeutics 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 LuViva Advanced Cervical Scan is an investigational device and is limited by federal law to investigational use in the United States.