The US Food and Drug Administration (FDA) has notified Guided Therapeutics that its premarket approval application (PMA) for the LightTouch Cervical Scanner, for patients at risk for cervical cancer, is 'suitable for filing.'
The FDA notification sets 23 September 2010 as the date of acceptance of the filing and states that it will schedule the Obstetrics and Gynecology Devices Panel meeting to review the PMA at a date to be determined.
In the pivotal trial to support the PMA filing, more than 1,600 women at risk for cervical disease were tested with the LightTouch, which detected cervical disease up to two years earlier than Pap test, HPV (human papillomavirus) test, colposcopy and biopsy.
Guided Therapeutics’ clinical trial indicated that women aged 16-20 were just as likely to have cervical disease as women 21 and older and current methods of early detection, such as HPV testing, are not recommended for this age group.
Guided Therapeutics said LightTouch detected cervical disease equally well in both adolescent and adult women.
Guided Therapeutics president and CEO Mark Faupel said receiving the ‘suitable for filing’ letter from the FDA is a significant milestone in the regulatory review process and means that our application was sufficiently complete and is ready for substantive review.
"This brings us one step closer to realizing our goal of improving the early detection of cervical disease and reducing the false positives and unnecessary biopsies that result with the current standard of care," Faupel said.