We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us
GLOBETECH PUBLISHING LLC

Download Mobile App




Events

ATTENTION: Due to the COVID-19 PANDEMIC, many events are being rescheduled for a later date, converted into virtual venues, or altogether cancelled. Please check with the event organizer or website prior to planning for any forthcoming event.

Blood-Based Liver Disease Test Could Replace Invasive Biopsy

By LabMedica International staff writers
Posted on 12 Sep 2022
Print article
Image: Highly accurate, safe, and scalable blood test could replace invasive liver biopsy (Photo courtesy of Metadeq)
Image: Highly accurate, safe, and scalable blood test could replace invasive liver biopsy (Photo courtesy of Metadeq)

Approximately one in four people worldwide, or approximately two billion people, have non-alcoholic fatty liver disease (NAFLD) and therefore are at risk of developing non-alcoholic steato-hepatitis (NASH). NASH is the most severe form of NAFLD, a silent disease associated with fatty deposit build-up of the liver. NASH leads to advanced liver diseases such as liver fibrosis (scarring), cirrhosis, and liver cancer, and may ultimately result in death. Currently, the only way to diagnose NASH is through the standard of diagnosis, invasive liver biopsy, which is expensive and is associated with significant complications and discomfort. Until now, no reliable blood test has been developed for either NASH or liver fibrosis. Most importantly, no available test can define the severity (stage), or monitor the progression, of either NASH or liver fibrosis. Now, a new test uses artificial intelligence (AI) to accurately predict the stages of the whole spectrum of liver diseases, from NAFLD to NASH and liver fibrosis.

Metadeq Inc. (Boston, MA, USA) has announced a breakthrough non-invasive blood test that utilizes two novel circulating proteins to accurately diagnose NASH and liver fibrosis, and can score the stages of both diseases, without the need for invasive liver biopsy. A study that set out to discover a more accurate liquid biopsy test in support of patient care identified two novel protein biomarkers, PLIN2 and RAB14, to assist in the diagnosis of patients with NASH and/or liver fibrosis. The ability of these proteins to detect both diseases was tested in cohorts with either NASH and/or liver fibrosis that were confirmed with liver biopsy, the current standard of diagnosis.

The test results show that the proteins can provide rapid and cost-effective testing to combat the growing epidemic of NASH and liver fibrosis. This could be an invaluable tool in diagnosing and monitoring cases of liver diseases, allowing people to receive earlier treatment, from lifestyle adjustments to surgical and pharmacological interventions. The Metadeq predictive algorithm, which uses A.I., provided unprecedented sensitivity (88-95%), specificity (90-100%), and overall accuracy (92-93%) for NASH, and also has near-perfect sensitivity (99%-100%), specificity (90%-96%), and accuracy (98%-99%) for liver fibrosis.

Currently no NASH drug has been approved by either the FDA or EMA, which may be a direct result of the lack of an accurate, reliable, and non-invasive test. More than 65% of patients who enroll in clinical trials for NASH-related therapies are found to be ineligible for the trial due to screen failure, which causes major monetary losses to companies developing and testing NASH drugs. The improved accuracy and ability to detect NASH staging will help in identifying and enrolling the appropriate people in clinical trials, speeding up the development of NASH drugs.

"This blood test will allow researchers and clinicians to define the prevalence of NASH across populations, including children and adolescents, avoiding the need for invasive liver biopsy," said Professor Geltrude Mingrone from the School of Cardiovascular and Metabolic Medicine & Sciences at King's College London, who led the study in collaboration with Metadeq. "Critically, it will allow care-givers to monitor the efficacy of NASH treatments over time, reducing screen failures and helping generate better drugs."

"Since HEPAR-Q is the only diagnostic modality that can diagnose NASH and fibrosis staging we expect it to be instrumental in the development of new therapeutics for the management of patients," said Frank Jaksch, Chairman of Metadeq. "We believe that HEPAR-Q will advance for the benefit of patients the problem of regular screening, that has resulted in late drug failures during clinical trials, since it is now possible to accurately measure the severity of disease in a non-invasive manner."

Related Links:
Metadeq Inc.

Gold Supplier
Quantitative Immunoassay Analyzer
FIA8000
New
STI Test
Rheonix STI TriPlex Assay
New
Real-Time Fluorescent Quantitative PCR System
AccuRa-32
New
Automated Immunoassay Analyzer
cobas e 411

Print article
IIR Middle East

Channels

Industry

view channel
Image: The global infectious disease IVD market is expected to hit USD 57 billion by 2030 (Photo courtesy of Pexels)

Global Infectious Disease IVD Market Dominated by Molecular Diagnostics Technology

The global infectious disease in vitro diagnostics (IVD) market stood at USD 113.7 billion in 2021 and is expected to grow at a CAGR of -7.41% from 2022 to 2030 to hit around USD 56.89 billion by 2030,... Read more
Copyright © 2000-2022 Globetech Media. All rights reserved.