Guided Therapeutics will initiate patient enrolment this week in a multi-centre, blinded clinical trial to expand claims for the LuViva Advanced Cervical Scan to include front-line screening for cervical cancer.
The clinical trial, which is expected to take six to nine months, will be conducted at Georgia Regents University in Augusta and CerviCusco in Peru.
It is expected to enroll between 600 and 800 women, with 160 women in Augusta and the remainder in Peru.
Study results will be used to update and validate LuViva’s software for use as a primary screener for cervical disease that leads to cancer.
Guided Therapeutics CEO Gene Cartwright said: "The lack of access to healthcare is a leading contributing factor to the large number of cases and the high death-rate from cervical cancer in developing countries.
"LuViva, which provides immediate results without the need for laboratory support, is an ideal technology to help fight cervical cancer with early detection."
Used in conjunction with the LuViva Cervical Guide single-use patient interface and calibration disposable, LuViva scans the cervix with light and uses spectroscopy to measure how light interacts with the cervical tissue.
Currently, LuViva is approved for use outside the US and is under premarket approval review by the US Food and Drug Administration (FDA).
It is approved for use in women identified as being at risk for cervical cancer by abnormal cytology (Pap), HPV test or previous cervical disease.