August 24, 2016 — Guided Therapeutics Inc. announced in late July that it has sold the first LuViva Advanced Cervical Scan to its distributor in Russia.
The LuViva will be used for marketing clinical studies and for testing as part of the approval process by the Russian Federal Service for Control over Healthcare and Social Development, more commonly known as "Roszdravnadzor." Approval is expected in 2017.
Cervical cancer is the second most diagnosed cancer among Russian women ages 15 to 44 years, with the highest cancer mortality rate, according to the 2016 ICO Information Centre on HPV and Cancer report fact sheet. There are 65.1 million women at risk of developing cervical cancer in Russia. Annually, 15,342 Russian women will be diagnosed with cervical cancer and 7,371 will die from the disease.
Worldwide, 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. There are about 2.6 billion women aged 15 years and older who are at risk of developing cervical cancer worldwide.
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. This 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.
LuViva 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 and calibration disposable.
For more information: www.guidedinc.com