Siemens Healthineers launches Enhanced Liver Fibrosis (ELF) Check within the U.S.

The Enhanced Liver Fibrosis (ELF) Check from Siemens Healthineers is now accessible in the USA, offering broad scientific entry to the minimally invasive prognostic software. Presently, the ELF Check is solely accessible by way of collaborations with Labcorp (NYSE: LH) and Quest Diagnostics (NYSE: DGX), offering entry (with a doctor’s order) throughout the nation. That is the primary time the take a look at is commercially accessible within the U.S., following De Novo advertising and marketing authorization from the U.S. Meals and Drug Administration (FDA) in August 2021.

The ELF Check is an easy, efficient blood take a look at with confirmed affected person outcomes information to evaluate prognosis in sufferers with superior fibrosis (F3 or F4) as a result of non-alcoholic steatohepatitis (NASH), a kind of non-alcoholic fatty liver illness (NAFLD) characterised by irritation of the liver. NASH impacts as much as 20 million folks within the U.S., and is predicted to be the main indication for liver transplant by 20301. The ELF Check makes use of a routine blood pattern and mathematical algorithm to generate a rating that assesses the danger of illness development. Clinicians can then make the most of the rating to grasp the probability of development to cirrhosis and different liver-related scientific occasions, and decide the suitable interventions and way of life adjustments to assist forestall additional organ injury.

“The supply of the ELF Check at main nationwide reference laboratories brings instant broad entry to sufferers and clinicians nationwide, offering the perfect chance to vary the panorama for NASH,” mentioned Jennifer Zinn, Head of Diagnostics, North America at Siemens Healthineers. “At Siemens, our hope is that broad accessibility of the ELF Check will give clinicians and sufferers a worthwhile prognostic software to assist catch extreme liver injury earlier than it reaches that time. A scan or biopsy can pinpoint present liver injury, which doesn’t essentially imply the affected person will progress to extreme illness. With the ELF Check, clinicians can pinpoint the probability of future development, and prescribe the suitable therapy and way of life adjustments to hopefully mitigate future injury.”

Now, there isn’t any excuse to not consider the prognosis of your sufferers which have superior fibrosis as a result of NASH as a result of this take a look at will change into accessible, hopefully, in all labs in the USA – I see the use for ELF in all of my sufferers, together with different noninvasive checks, and that’s how I’d advocate it to different gastroenterologists and hepatologists.”

Dr. Mazen Noureddin, Cedars-Sinai Medical Heart, Los Angeles

NASH is usually referred to as a ”silent killer,” since sufferers sometimes don’t exhibit signs till the illness has progressed to the purpose of great organ injury. Now, with widespread availability of the ELF Check at nationwide reference laboratories, clinicians have entry to a handy and minimally-invasive prognostic software, which will be examined with a easy routine blood draw.

1 Estes, C,, Razavi, H., Loomba, R., et al. (2018). Modeling the epidemic of nonalcoholic fatty liver illness demonstrates an exponential improve in burden of illness. Hepatology. 67(1):123-33.

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