Guided Therapeutics Inc 13500 Manuel D’Utilisation
November 2013, CNDS-0-635-MAN_3
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15. Performance Characteristics
LuViva
®
Advanced Cervical Scan indicates the likelihood of Cervical Intraepithelial Neoplasia Grade II and higher
(CIN2+) in a referred population (See Indications for Use) at the time the scan is given to the patient. The likelihood
of CIN2+ is presented on a three-point scale: Low (Green), Moderate (Yellow) and High (Red).
LuViva generates the scale by using proven spectroscopy technology to capture spectral data from multiple points on
LuViva generates the scale by using proven spectroscopy technology to capture spectral data from multiple points on
the cervix and the distal endocervix. The data are integrated into LuViva’s algorithm to produce the index indicating
the likelihood of CIN2+.
LuViva’s pivotal clinical trial of 1,330 patients, referred for additional testing after screening, prospectively
demonstrated that as the index increased in magnitude, so did the likelihood of CIN2+, as documented by quality-
LuViva’s pivotal clinical trial of 1,330 patients, referred for additional testing after screening, prospectively
demonstrated that as the index increased in magnitude, so did the likelihood of CIN2+, as documented by quality-
controlled, multi-reader histopathology results.
According to the pivotal clinical trial results, a patient with CIN2+ is approximately four times more likely to be in the
High (Red) category than the Low (Green) category and a patient with CIN3+ (including cancer) is approximately
According to the pivotal clinical trial results, a patient with CIN2+ is approximately four times more likely to be in the
High (Red) category than the Low (Green) category and a patient with CIN3+ (including cancer) is approximately
seven times more likely to be in the High (Red) category than the Low (Green) category. A patient in either the Low
(Green) or Moderate (Yellow) category is least likely to harbor a CIN2+ lesion. (Chart 1)
(Green) or Moderate (Yellow) category is least likely to harbor a CIN2+ lesion. (Chart 1)
The Low (Green) category contains the most normal and CIN1 cases (95%) and fewest CIN2+ (5%). The High (Red)
category contains the most CIN2+ cases (20%) and fewest normal (36%) and CIN1 (44%) cases. The Moderate (Yellow)
category contains the most CIN2+ cases (20%) and fewest normal (36%) and CIN1 (44%) cases. The Moderate (Yellow)
category is most likely to contain a mix of normal and CIN1 (84%) cases with some CIN2+ cases. (Table 1)