Guided Therapeutics, a developer of LightTouch - a rapid, non-invasive and painless test for the early detection of cervical pre-cancer currently under review at the FDA, was awarded ISO 13485:2003 registration certification.
LightTouch is designed to provide an objective result at the point-of-care, thereby improving the management of cervical disease.
The certificate of registration was issued by Intertek Testing Services, a provider of quality and safety solutions, serving a wide range of industries around the world.
Guided Therapeutics CEO and president Mark Faupel said they believe that the LightTouch has significant market potential outside the US and this certification demonstrates that the company has created a high-quality and world-class organization for the design, manufacture and distribution of their products internationally.
Guided Therapeutics has also entered into a partnership with Konica Minolta Opto to develop a non-invasive test for Barrett’s Esophagus using the LightTouch technology platform.