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TEST BASED ON METABOLOMIC TECHNOLOGY

OWLiver®

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DIAGNOSTIC INDICATIONS DIAGNOSTIC PRINCIPLE References

DIAGNOSTIC INDICATIONS

The OWLiver® test is a serum-based non-invasive diagnostic method that, by means of a lipidomic analysis of fasting blood samples, allows:

  • Reliably diagnose the patient in all harmful phases of MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
  • Monitor the follow-up of the patient, ensuring surveillance of the regression or progression of the MASLD phases.

DIAGNOSTIC PRINCIPLE

The lipids of the OWLiver® panel are determined by high performance liquid chromatography coupled to mass spectrometry (UHPLC-MS). The relative concentrations of these lipids, together with ALT, AST and body mass index (BMI), are analyzed together in three algorithms that reflect the liver fat content, inflammation, and fibrosis.

The OWLiver® panel has been developed to estimate the stage of MASLD and is based on a prospective study in which patients had been previously diagnosed using the gold standard for this disease, liver biopsy. The OWLiver® panel was developed in a multicenter and multiethnic study, which included patients with a BMI greater than 25 kg / m2 and with different degrees of type 2 diabetes mellitus, including non-diabetics, controlled diabetics and diabetics with poor glycemic control.

Developed by Rubió Metabolomics, S.L.U., the OWLiver® Panel is a CE-marked in vitro diagnostic medical device, complying with Directive 98/79/EC.

 

References

  1. Barr J, Caballería J, Martínez-Arranz I, Domínguez-Díez A, Alonso C, Muntané J. Obesity-dependent metabolic signatures associated with nonalcoholic fatty liver disease progression. J Proteome Res. 2012;11(4):2521-32.
  2. Mayo R, Crespo J, Martínez-Arranz I, Banales JM, Arias M, Mincholé I. Metabolomic-based noninvasive serum test to diagnose nonalcoholic steatohepatitis: Results from discovery and validation cohorts. Hepatology Communications 2018;2(7):807-20.
  3. Ortiz P, Mincholé I, Mayo R, Martínez-Arranz I, Banales JM, Arrese M. Serum metabolomics-based steatohepatitis score for the non-invasive identification of patients with non-alcoholic steatohepatitis (NASH) in multiethnic, including type 2 diabetes mellitus population. J Hepatol, vol. 75, Suppl. 2, Jun. 2021.
  4. Noureddin M, Truong E, Mayo R, Ibon Martínez-Arranz I, Mincholé I, Banales JM. Serum identification of At-Risk MASH: The Metabolomics-Advanced steatohepatitis fibrosis score (MASEF). Hepatology. 2024 Jan 1;79(1):135-148.doi: 10.1097/HEP.0000000000000542. Epub 2023 Jul 24.
  5. Iruzubieta P, Mayo R, Mincholé I, Martínez-Arranz I, Arias-Loste MT, Ibañez-Samaniego L. One-step non-invasive diagnosis of metabolic dysfunction-associated steatohepatitis and fibrosis in high-risk population. United European Gastroenterology Journal. 2024 (in press)

In vitro diagnostic medical device with CE marking.

For more information contact: owliver@labrubio.com

Marketed and distributed by Cima Sciences in the USA (https://cimasciences.com/) and by Rubió Metabolomics in the rest of the world (https://owlmetabolomics.com/).

Developed by: Rubió Metabolomics, S.L.U.

Ownership: Rubió Metabolomics, S.L.U.

 

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