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In recent AASDL submissions, some are surprised by the number of studies that refer to diabetes subpopulations.

This is not a coincidence but simple strategy.

As drugs approach market access, it becomes clear that the limiting factor in this market will be the identification of patients to be treated.

All agree that it is not feasible to perform diagnostics by large-scale liver puncture, both for reasons of lack of specialists and for economic reasons. It is therefore necessary to quickly validate a sufficiently reliable non-invasive diagnostic technique as an alternative to biopsy.

This is why the latest data published by GENFIT on its NIS4 test are important. They have begun to disseminate and sell these tests for use as a pre-diagnostic method in clinical studies of other laboratories and there are already several laboratories that will use the NIS4 test when screening their clinical studies to limit the number of control biopsies.

Some worried that the latest study published on NIS4 was limited to a population of diabetic patients and inferred that the test would not be valid for the rest of the NASH patients.

Well no, this is not the reason for all these studies specifically targeting diabetic populations.


How to find some NASH patients quickly

The real reason is that the identification of NASH patients will be much faster for diabetic patients than for others and that the need to get cash back quickly after decades of study is a top priority for laboratories in the world waiting for the NASH global market take its place.

The prevalence of diabetic patients in the US is, according to a 2015 study, 9.4% of the population. Of this US population, it is considered that 75% are diagnosed (in France this rate is estimated at 79%).

That's 23 million of identified US patients who are monitored annually by their doctors and easy to address.

However, the prevalence of NASH in patients with T2D is estimated at about 30% according to the studies. This largely justifies that diabetic patients be tested for NASH first.

This of course has an immediate impact on the number of tests to be performed, if 50% of US diabetic patients are prescribed a NASH serological test, that is almost 11 million tests that can be sold in the US very quickly as soon as its marketing.

It would even make sense to extend these tests to pre-diabetic patients

In terms of treatments, the laboratories did a similar analysis!

Knowing that the first patients diagnosed will be overwhelmingly diabetic patients for the reasons previously seen, it is necessary to demonstrate as soon as possible effectiveness on this population so that treatments are prescribed quickly. This is the purpose of all these studies published on diabetic subpopulations of NASH patients

They know that the rest of the NASH population will be longer to identify and take over as the NASH market matures.

Laboratories targeting NASH who feel the need for a quick return on investment know very well what they do by insisting on the diabetic population.

G Divry 2019

Notice that I am neither a physician nor a biologist, my point of view is only that of an enlightened amateur, so it must be taken for what it is, a questionable point of view

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