LiverScope®
Accurate and Fast Point-of-Care Diagnostics
“An estimated 80 million to 100 million Americans have nonalcoholic fatty liver disease, which causes the liver to swell with dangerous levels of fat. Roughly seven million of those are adolescents and teenagers. Fatty liver disease typically has few symptoms, and many people who have it don’t know it.”
The New York Times – To Fight Fatty Liver, Avoid Sugary Foods and Drinks.
LiverScope®
Revolutionary Point-of-Care Liver Disease Diagnostics
Benefits
- Accuracy
- Short time to results
- Open design. Clothes on. No claustrophobia issues
- Low ownership and operational costs
- Simple training. No need for analysis by a radiologist
- Burden-free test scheduling
LiverScope® has not been cleared by the FDA.
LiverScope®, Liver Disease Diagnostics
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.
Advantages
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.
Today’s gold standard for diagnosis purposes is a biopsy, which is invasive and expensive. Ultrasound is limited in fat measurement accuracy. MRI is accurate but expensive. Livivos addresses the urgent need to diagnose liver disease with the high accuracy of MRI at the low-cost of ultrasound.
Convenience for Patients & Operators
Cost, scheduling, and comfort advantages open the possibility for frequent and accurate liver disorder diagnosis. LiverScope® supports disease prevention, effective monitoring, and proper clinical treatment management.
Performance Validation - Liver Fat
Calibration Standards
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.
In-Vivo Studies
Clinical Study at University of California, San Diego
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).
LiverScope® liver fat measurements show remarkable equivalence to MRI PDFF
Linear Correlation R-squared > 0.94
Reference:
Point-of-care magnetic resonance technology to measure liver fat: Phantom and first-in-human pilot study. Magnetic Resonance in Medicine, 2022 Oct;88(4):1794-1805.
Volunteer Study Details
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).
Market-leading Performance
Emerging Point-of-Care liver fat diagnosis methodologies use MRI PDFF as the gold standard for clinical performance. As the LiverScope® uses the same principles as MRI PDFF, it is no surprise that unprecedented high correlation is attained in clinical comparisons.
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LiverScope® is an investigational medical device. It has not been cleared by the FDA at this time.
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