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Guided Therapeutics, Inc. is the maker of 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 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.
LuViva doesn’t require a patient sample or a laboratory, and a result is given in approximately 1 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.
