CIMA Sciences OWLiver Test Shows Promising Results in LITMUS Study

HOUSTON, Nov. 11, 2026 /CourierPR/ -- CIMA Sciences, a company that develops noninvasive diagnostic technologies, has highlighted new evidence for its OWLiver® blood test from a landmark study published in The Lancet. The study, known as LITMUS, evaluated 30 noninvasive markers and panels against liver biopsies among 1,590 adults at 37 specialist liver centers across 13 countries, providing a rigorous evaluation of noninvasive liver tests.

The OWLiver-MASH marker, a key component of the OWLiver® test, demonstrated a 79% positive predictive value (95% confidence interval [CI], 59%, 91%) for identifying biopsy-confirmed at-risk metabolic dysfunction-associated steatohepatitis (MASH) with fibrosis stage F2 or higher. This means that, on average, nine patients needed to be tested to identify one eligible case. The OWLiver-MASEF marker, another marker of the OWLiver® test, achieved a 100% observed positive predictive value (95% CI, 76%, 100%), indicating a high level of accuracy in identifying patients with clinically significant fibrosis.

The LITMUS study, published in the October 31 issue of The Lancet, is part of a broader effort to identify patients with fatty liver disease beyond advanced fibrosis. MASLD, or metabolic-associated fatty liver disease, can progress from excess fat in the liver (steatosis) to an inflammatory form of the disease (MASH) and to clinically significant fibrosis. Within LITMUS, at-risk MASH was defined as MASH with fibrosis stage F2 or higher, an important distinction as care teams seek to identify patients who may warrant further evaluation and management.

The OWLiver® test uses metabolomics-based blood testing to assess liver fat, inflammation, and fibrosis-associated risk. It is designed to characterize MASLD, early MASH (F0, F1), and at-risk MASH (F≥2). While the broader intended use of OWLiver® draws on separate validation research, the LITMUS study focused on the OWLiver MASH and MASEF markers.

The findings are especially relevant to clinical-trial screening, where reducing unnecessary biopsies while identifying eligible patients is a priority. In the study's overall diagnostic analysis, performance varied among biomarkers; only one panel significantly exceeded the prespecified AUC benchmark for at-risk MASH, and no test met that benchmark for MASH alone.

CIMA Sciences continues to advance noninvasive diagnostic technologies for high-prevalence medical conditions, with OWLiver® being developed by Rubió Metabolomics and offered in the United States by CIMA Sciences. The OWLiver blood test is designed to help clinicians assess MASLD and MASH across clinically relevant stages.