Guided Therapeutics Achieves Regulatory Approval for Sale in India

Guided Therapeutics Inc. has received Regulatory Approval from the Indian Ministry of Health & Family Welfare to allow commercialization of the LuViva device and disposables. The Ministry concluded that the LuViva device is “non invasive” and as such is “not regulated under the Drugs and Cosmetics Act 1940 and Medical Device Rules 2017 thereunder.” As a result, LuViva can now be commercialized in India.
 
“There are approximately 330 million women who are age appropriate for cervical cancer screening in India,” said Gene Cartwright, CEO. “Only a small percentage of age appropriate women are screened today in India due to the logistical complications of using other methods of cervical cancer screening. LuViva is an attractive alternative because it doesn’t require a patient sample or a laboratory, and a result is given in approximately one minute at the point of care.”
 
There are about 2.6 billion women aged 15 years and older who are at risk of developing cervical cancer worldwide. The world 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.
 
LuViva is a technologically advanced 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.
 
Guided Therapeutics Inc. 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 Guided Therapeutics LuViva Advanced Cervical Scan is an investigational device and is limited by federal law to investigational use in the United States.