Guided Therapeutics, Inc. has received an order and payment for a third LuViva Advanced Cervical Scan and 500 single-use disposable cervical guides for Bulgaria.
LuViva is a diagnostic device that scans the cervix with light and uses spectroscopy to measure how light interacts with the cervical tissue. Spectroscopy identifies chemical and structural indicators of precancer that may be below the surface of the cervix or misdiagnosed as benign. The technique is called biophotonics.
Unlike Pap, HPV tests or biopsies, LuViva does not require laboratory analysis or a tissue sample, and is designed to provide results immediately, which may result in eliminating costly, painful and unnecessary additional testing. It is intended for use with women who have undergone initial screening and are called back for follow up with a colposcopy examination, which in many cases, involves taking a biopsy of the cervix.
It has also been used in clinical studies in Turkey and Nigeria as a means to screen women for cervical cancer where the availability of infrastructure necessary for Pap and HPV testing is restricted. The device is used in conjunction with the LuViva Cervical Guide single-use patient interface.
World-wide, the market for cervical cancer screening and diagnostics, as currently practiced using cytology (Pap test) for primary screening, is estimated at $6 billion and is projected to grow to almost $9 billion by 2020.
Bulgaria has a population of more than 3.2 million women ages 15 years and older who are at risk of developing cervical cancer. Current estimates indicate that every year 1,254 women are diagnosed with cervical cancer and 437 die from the disease. Cervical cancer ranks as the 2nd most frequent cancer among women between 15 and 44 years of age in Bulgaria. Worldwide there are about 2.6 billion women who are at risk.
LuViva Advanced Cervical Scan is an investigational device and is limited by federal law to investigational use in the U.S.