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Mufaso

05/24/23 10:22 AM

#247144 RE: DewDiligence #247139

In the test cohort, NIS2+™ exhibited a statistically higher AUROC (0.813) vs NIS4® (0.792; p=0.0002), FIB-4 (0.653; p<0.0001), and ALT (0.699; p<0.0001). NIS2+™ scores were not affected by age, sex, body mass index, or T2DM status, providing robust clinical performances irrespective of patient characteristics.


I copied the above quote from the article you posted (Thanks for the link Dew!). The quote above shows AUROC scores for various biomarkers. This test does offer an incremental improvement over GNFT's prior test (NIS4) and does promise to be a useful screening tool.

For those of you reading this not familiar with AUROC - here is a definition: AUC ROC stands for “Area Under the Curve” of the “Receiver Operating Characteristic” curve. As for how to interpret scoring in general, an AUC of 0.5 suggests no discrimination (i.e., ability to diagnose patients with and without the disease or condition based on the test), 0.7 to 0.8 is considered acceptable, 0.8 to 0.9 is considered excellent, and more than 0.9 is considered outstanding.

I thought I would add some info on MRE (Magnetic Resonance Elastography) and Biopsy for comparison to the biomarker tests quoted by Genfit.

MRE is thought to have an AUROC of better than 0.87 but is an expensive test and currently only available at 1000 sites globally. It was invented at the MAYO Clinic and they have some good info on it on their site:

https://www.mayoclinic.org/tests-procedures/magnetic-resonance-elastography/about/pac-20385177

Here is a link to a study that examined the diagnostic accuracy of magnetic resonance elastography (MRE) combined with FIB-4 in diagnosing ≥ stage 2 fibrosis. They get to an AUROC of 0.93 for the detection of ≥ stage 2 fibrosis.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8131405/

Liver Biopsy "the gold standard" but it too has some issues. It has an AUROC of around 0.87. Issues are that when you take the biopsy, you get a very small piece of the liver that may not be representative of the entire liver. It is expensive and subject to interpretation of clinicians. Here is a short old youtube video commissioned by GNFT from 4 years ago: