OWLiver - Product description
Non-alcoholic fatty liver disease (NAFLD) is a highly-prevalent progressive chronic disease in which the liver displays histological features similar to those induced by excessive alcohol intake but in the absence of alcohol consumption. NAFLD is very common in diabetics and the obese. Its early identification is important due to the burden of the disease and the fact that NAFLD often presents with only mild or no symptoms.
The rapid and early identification of fatty liver is important to prevent further progression of the disease.
Non-alcoholic steatohepatitis (NASH), defined as steatosis together with necroinflammatory lesions, is one latter stage in the spectrum of NAFLD, which ranges from benign hepatic steatosis to cirrhosis and liver failure.
OWL has developed OWLiver® Care and OWLiver®, non-invasive assays for fatty liver screening and for NASH diagnosis, respectively. Both of these tests use highly sensitive laboratory processes to determine the form of disease present in the patient’s liver.
OWLiver® Care test
Routine liver enzyme testing has been traditionally employed to estimate the presence of fatty liver disease, but the sensitivity and specificity of such tests are not adequate to guide medical decisions. Echography or other non-invasive imaging approaches can usually provide information about the presence of fatty liver.
Also, some newer non-invasive diagnostic tests have been developed using ultrasound or MR-technology to estimate severe steatosis and liver fibrosis. Unfortunately, all of the scanning technologies require special, more costly equipment, an operator and the test cannot be performed where the scanning equipment is absent.
The OWLiver® Care assay can be performed using a simple blood draw.
The OWLiver® Care test has been validated in clinical practice and compared directly to the results of invasive liver biopsies, the gold standard for NASH and NAFLD diagnosis. The OWLiver® Care test is a very robust diagnostic for the presence of non-alcoholic fatty liver, including patients with isolated hepatic steatosis and only mild non-specific liver inflammation.
The NAFL patient has no histopathological hepatocellular injury or fibrosis, but the identification of this early stage of fatty liver involvement is important in the patient care cascade.
OWLiver® test
The current clinical diagnosis for NASH includes liver biopsy, a cumbersome invasive procedure associated with the risk of severe complications.
The identification of early stages of the disease using robust new non-invasive diagnostics provides advanced information for patients at greater risk of suffering from NASH: for example, the diabetic, obese populations.
On many occasions, NASH diagnosis is provided only after serious liver scarring or cirrhosis is already present. When the disease worsens, liver transplant is frequently the only remaining treatment option.
In fact, transplant is increasingly performed in people with NASH, a situation presenting a real burden on healthcare systems worldwide.
Therefore, an early and non-invasive diagnosis (blood test) could help identify the high-risk populations who are most likely to develop NASH. Changes in lifestyle and repeat lab testing would allow easy follow up and monitoring of patient disease progression, while avoiding the costs and complications of other more complex diagnostic procedures.
The OWLiver® test can discriminate the NAFL patient from the more serious NASH patient. This simple blood test could also help influence the physician’s decision about the need for, and timing of, more expensive clinical testing on the patient.
Moving forward, the OWLiver® test may help guide the most appropriate use of new classes of pharmacotherapeutics and could also soon reduce the need for initial or follow-up invasive liver biopsies.
Video OWLiver TEST
OWLiver is:
- The first CE- marked in vitro blood based diagnostic for Steatosis and NASH based on metabolic procedures.
- Non invasive test. Allows easy follow up of patient progression.
- Entirely patented and developed by OWL.
- In vitro diagnosis system: Sample delivery to OWL laboratory .