Login
For Clinician Providers
For Clinician Providers
For Patients
A NON-INVASIVE BREAKTHROUGH IN LIVER DISEASE DIAGNOSIS
ACCU Reference Medical Lab, in partnership with CIMA Sciences, proudly offers the OWLiver® test—a cutting-edge, non-invasive blood test designed to detect all stages of Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD) and Metabolic dysfunction-Associated Steatohepatitis (MASH). Utilizing advanced metabolomics technology, OWLiver® provides clinicians with a reliable tool for early diagnosis and monitoring of liver disease progression, eliminating the need for invasive liver biopsies.
Understanding MASLD and MASH
MASLD, formerly known as Non-Alcoholic Fatty Liver Disease (NAFLD), is the most prevalent chronic liver condition in the United States, affecting over 30% of adults. It is closely associated with obesity, type 2 diabetes, and metabolic syndrome. As MASLD progresses, it can develop into MASH, characterized by liver inflammation and fibrosis, potentially leading to cirrhosis and hepatocellular carcinoma (HCC) if left undiagnosed and untreated.
Updated Disease Classification: From NAFLD/NASH to MASLD/MASH
In June 2023, an international consensus panel of liver disease experts endorsed a new nomenclature for fatty liver disease. The previous terms NAFLD (Non-Alcoholic Fatty Liver Disease) and have been officially replaced to reflect improved clinical understanding and to better align with underlying metabolic dysfunction.
Why the Change?
Old terminology (NAFLD/NASH) was
defined primarily by the absence of alcohol consumption and lacked emphasis on metabolic risk factors.
The new terms MASLD and MASH directly reflect the presence of metabolic dysfunction, which is now known to be central to disease progression.
This change helps standardize diagnosis and research globally and provides clarity for physicians treating patients with metabolic conditions.
New Terminology Overview
OLD TERM |
NEW TERM |
DEFINITION |
|---|---|---|
NAFLDNon-Alcoholic Fatty |
MASLDMetabolic dysfunction- |
Presence of ≥5% liver fat (steatosis) in patients with at least one of five metabolic risk factors (e.g., T2D, obesity, hypertension) |
NASHNon-Alcoholic |
MASHMetabolic dysfunction- |
A progressive form of MASLD with inflammation and liver cell damage (ballooning), with or without fibrosis |
NAFLNon-Alcoholic Fatty Liver |
Steatotic Liver
|
Encompasses all liver conditions characterized by steatosis, including MASLD and alcohol-associated SLD |
Cryptogenic
|
Burnt-out
|
End-stage cirrhosis believed to originate from previously undiagnosed metabolic liver disease |
Key Clinical Notes
MASLD is a diagnosis of inclusion, not exclusion: unlike NAFLD, MASLD does not require ruling out alcohol intake, as long as metabolic dysfunc-tion is present.
MASH replaces NASH but retains its clinical significance: it is the inflammatory subtype with the highest risk for fibrosis, cirrhosis, and hepatocellular carcinoma.
The OWLiver® test aligns with the new classification by detecting MASH and identifying patients at risk of progressive fibrosis, as per current international consensus.
New Terminology Overview
OLD TERM |
NEW TERM |
DEFINITION |
|---|---|---|
NAFLDNon-Alcoholic Fatty |
MASLDMetabolic dysfunction- |
Presence of ≥5% liver fat (steatosis) in patients with at least one of five metabolic risk factors (e.g., T2D, obesity, hypertension) |
NASHNon-Alcoholic |
MASHMetabolic dysfunction- |
A progressive form of MASLD with inflammation and liver cell damage (ballooning), with or without fibrosis |
NAFLNon-Alcoholic Fatty Liver |
Steatotic Liver
|
Encompasses all liver conditions characterized by steatosis, including MASLD and alcohol-associated SLD |
Cryptogenic
|
Burnt-out
|
End-stage cirrhosis believed to originate from previously undiagnosed metabolic liver disease |
Key Clinical Notes
MASLD is a diagnosis of inclusion, not exclusion: unlike NAFLD, MASLD does not require ruling out alcohol intake, as long as metabolic dysfunc-tion is present.
MASH replaces NASH but retains its clinical significance: it is the inflammatory subtype with the highest risk for fibrosis, cirrhosis, and hepatocellular carcinoma.
The OWLiver® test aligns with the new classification by detecting MASH and identifying patients at risk of progressive fibrosis, as per current international consensus.
OWLiver® employs two proprietary algorithms:
OWLiver® MASH Algorithm: Identifies the presence of MASH.
MASEF® (Metabolomics-Advanced Steatohepatitis Fibrosis) Score: Detects “at-risk” MASH, indicating significant fibrosis (F≥2).
By analyzing these biomarkers, OWLiver® classifies the patient’s liver condition into one of the following categories:
Clinical Benefits of OWLiver®
Clinical Guidelines and Indications
The OWLiver® test is indicated for:
The test aligns with clinical practice guidelines emphasizing the importance of non-invasive methods for diagnosing and monitoring liver disease.
OWLiver® reports provide:
STEATOSIS or NO MASLD
MASH (F0-F1)
MASH with significant fibrosis (F≥2)
Test Ordering and Specimen Requirements
TEST ORDERING CODE: 045Y
|
Specimen |
Fasting serum sample. Patient must fast at least 8 hours before the test |
|
Volume |
Minimum of 0.5 mL |
|
Container |
Serum separator tube (SST) without anticoagulant. Please collect 2 tubes |
|
Processing |
Centrifuge and separate serum within 45 minutes of collection |
|
Storage |
Refrigerate at 4°C. Do not freeze! |
|
Shipping |
Transport samples on ice pack to the laboratory |
|
Turnaround time |
2 weeks |
|
Requisition form |
Patient’s BMI or HEIGHT AND WEIGHT must be recorded on the requisition form |