LiverScope® has not been cleared by the FDA.
LiverScope® uses a custom probe and miniaturized electronics for open-access, in-vivo data collection. The diagnosis is completed with remarkable operational simplicity providing an automated readout. Recurring low-cost testing makes Livivos’s economical and accurate modality attractive to pharma, clinicians, liver specialists, health insurance providers, and patients.
Effective diagnosis of NASH has been challenging, as most patients in early stages of the disease show no symptoms. Diagnosis is currently not possible via a typical physical examination and conventional accurate diagnostic methodologies are invasive, costly, or both. LiverScope®’s point-of-care methodology offers an unmatched combination of accuracy, patient comfort, and low per-test cost.
QUANTIFICATION of liver fat is key for assessing liver health as many treatments are directed at reducing liver fat (anti-steatotic). Measuring fat accurately helps determine the treatment’s mechanism and efficacy.
LiverScope® reads the Proton Density Fat Fraction (PDFF), a measure of liver fat which was developed for clinical MRI. The diagnosis is completed without the need for a radiologist.
The LiverScope® performance was quantified using a series of phantom samples from Calimetrix. The PDFF of the reference samples is certified by the manufacturer. Calimetrix provides advanced quantitative MRI PDFF reference specimens for clinical and research measurements.
LiverScope® PDFF values show a high linear correlation to certified MRI PDFF values, with an R-square > 0.99. The quantitative method provides a reliable means for steatosis grading.
The LiverScope®‘s performance was evaluated with an in-vivo clinical study with volunteer patients at UC San Diego. For each patient, the Livivos’s PDFF results were compared to the PDFF attained by the FDA-cleared MRI method (GE IDEAL IQ).
UC San Diego Institutional Review Board. Title: Feasibility Comparative Study of MRI Proton Liver Density Fat Fraction (PDFF) and LiverScope® PDFF.
Principal Investigator: Eduardo Grunvald, M.D. Medical Director, UC San Diego Weight Management Program. Clinical Professor of Medicine.
LiverScope® Scans: UC San Diego Bariatric and Metabolic Institute. 4520 Executive Drive, Suite 111. San Diego, CA 92121.
MRI Scans & Analysis: UC San Diego Center for Translational Imaging and Precision Medicine (CTIPM), Altman Clinical and Translational Research Institute (ACTRI).