Guided Therapeutics Announces Filing of Application for NMPA Approval to Market and Sell LuViva in China
Guided Therapeutics Inc (GTHP)
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Source: Business Wire
PEACHTREE CORNERS, Ga.--(BUSINESS WIRE)--Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, announced today that its Chinese Partner, Shandong Yaohua Medical Instrument Corporation (SMI), has filed its application for LuViva with the Chinese National Medical Products Administration (NMPA). The application included results from 449 women tested at four leading medical institutions in China. The results of the study were above that required for a successful study as defined by the study protocol, with a test sensitivity of 83% and a test specificity of 54%.Sensitivity and specificity describe the accuracy of a test that reports the presence or absence of a disease, in this case cervical precancers and cancers. Individuals who have the disease are considered "positive" and those who do not are considered "negative". Sensitivity is a measure of how well a test can identify true positives and specificity is a measure of how well a test can identify
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Sec Filings
- 11/14/24 - Form SCHEDULE
- 11/14/24 - Form 10-Q
- 10/25/24 - Form 4
- GTHP's page on the SEC website