Siemens blood test for fatty liver disease obtains de novo clearance from FDA

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Although it is predicted to become a major cause of organ damage and liver transplants during this decade, treatments for non-alcoholic fatty liver disease, or NAFLD, have stalled for one simple reason: it can be difficult to tell who has the disease and who does not. .

But now the FDA has granted groundbreaking clearance for a blood test from Siemens Healthineers that aims to provide a simpler and potentially more accurate alternative to invasive tissue biopsy. The agency’s de novo green light covers the Advia Centaur Enhanced Liver Fibrosis Test, or ELF test, which has been available internationally for more than 10 years.

As a prognostic tool, it measures three blood indicators of liver scarring and can help predict which patients may progress to advanced cirrhosis. It can also be used to assess those who may see complications related to the liver due to the dangerous subtype of NAFLD, non-alcoholic steatohepatitis, also known as NASH. If left untreated, NASH can ultimately lead to organ damage and liver cancer.

Tests that look for signals covering the entire liver are important because NAFLD and NASH do not spread evenly throughout the organ. Although this is the current gold standard, a painful biopsy sample can ignore the progress of the disease, removing tissue from a less affected area. Additionally, an ultrasound may show fatty deposits in the liver, but cannot determine which may progress to more serious disease.

RELATED: Genfit Diagnostic Pivot Offers Bright Spot After Major NASH Drug Flop

Other companies such as Genfit have pursued a non-invasive test for NASH, including a blood diagnostic that was exploited by Labcorp last year for marketing to primary care clinics after previously offering the test to biopharmaceutical companies. as part of its drug development. targeted business.

Elsewhere, former Fierce 15 winner Glympse Bio developed a NASH diagnosis that begins with an injection of particles that interact with fibrotic processes and enzymes in the liver and emit a positive signal when they are flushed out of the body.

RELATED: Pfizer Drops Perspective Of Mid-Phase NASH, A Multitude Of Early Efforts In Second Quarter Cleanse

Therapeutically, NASH and NAFLD treatments have seen their ups and downs, with Pfizer recently dropping its third drug candidate for the disease after poor performance in a Phase 2 trial of 164 patients.

But smaller companies such as Enyo Pharma and Hepion Therapeutics made progress halfway through. Enyo’s vonafexor has been shown to help reduce liver fat and improve kidney health, while Hepion’s CRV431 will move to larger trials after completing safety studies in humans .

Editor’s Note: This story has been corrected to show that the FDA clearance covers the use of the test as a prognostic tool, not a diagnostic test.


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