USA – Siemens Healthineers has launched its Enhanced Liver Fibrosis (ELF) test, a minimally invasive prognostic tool following FDA De Novo marketing authorization in August.
The ELF Test is a blood test used to determine prognosis in patients with advanced fibrosis (F3 or F4) caused by non-alcoholic steatohepatitis (NASH), a type of non-alcoholic fatty liver disease (NAFLD) characterized by liver inflammation.
NASH, also known as the “silent killer,” does not usually cause symptoms until the disease has progressed to the point of severe organ damage.
The ELF Test generates a score based on a routine blood sample and a mathematical algorithm that assesses the risk of disease progression.
Clinicians can then use the score to predict the progression to cirrhosis and other liver-related clinical events, as well as the appropriate interventions and lifestyle changes to help prevent further organ damage.
The ELF Test is currently only available through collaborations with Labcorp and Quest Diagnostics.
According to the company, this is the first time the test will be commercially available in the United States, following De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) in August 2021.
NASH affects up to 20 million people in the U.S., and it is predicted to be the leading indication for liver transplant by 2030, Siemens said, citing research data.
In other news, BD (Becton, Dickinson and Company) has announced the addition of a new MX instrument to the BD COR System for high-throughput molecular testing of infectious diseases.
The new instrument, as well as its first test for sexually transmitted infections, has received CE certification.
BD also stated that it has applied for marketing authorization in the United States with the Food and Drug Administration (FDA).
BD said the MX instrument “is the final piece of the BD COR System, which also includes a PX instrument that can prepare diagnostic samples by automating appropriate pre-analytical processing steps and a GX instrument that can leverage the BD Onclarity HPV Assay with extended genotyping to screen for HPV infections.”
The first test available on the MX instrument is the BD CTGCTV2 for BD COR System, which is designed to detect the three most common non-viral sexually transmitted infections — Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC), and Trichomonas vaginalis (TV) — using a single test.
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