Guided Therapeutics, Inc. of Norcross recently announced that a general agreement with the United States Food and Drug has potentially been reached, meaning in can submit an application for its LuViva Advanced Cervical Scan product to be approved.
The company makes platforms for rapid and painless testing, and this product does not require taking a tissue sample to detect cervical pre-cancer. Results are provided immediately, and it is unlike any other technology for health cancer detection on the market. Europe, Mexico, and Canada have already approved the product, and it is currently available to women in 20 countries.
The agreement was based on a meeting between two leading OBGYNs (obstetricians and gynecologists) in the United States, the company, and reviewers from the agency, which include a new OBGYN physician and a new lead reviewer.
According to Gene Cartwright, CEO of Guided Therapeutics, the meeting objectives were met and the company is looking forward to working with the new lead OBGYN physician and the lead reviewer to obtain approval for the product in the United States. Over the next two to three months, details of the approval plan will be worked out and there will be a clinical trial for collecting additional data from patients.
The company will most likely be using the services of printing companies as it prints outs the many surveys and reports that will be required during the approval process.
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