Established in 2003, BIOAXXESS® started as a technology and business consultancy for innovative biochemicals and diagnostics kits. Benefitting from our in-depth knowledge and long-standing experience for their products we now represent the original manufacturer PEVIVA, Sweden.
PEVIVA is the original developer and manufacturer of the well-established M30-CytoDEATHTM Monoclonal Antibody directed against the caspase-cleaved neo-epitope M30 of Cytokeratin-18 (K18Asp396-NE, ccK18, K18F-M30).
PEVIVA's first-in-class CE-certified IVD cell death biomarker assays
M30-Apoptosense ELISA® (apoptotic Cytokeratin-18, ccK18, CK18 fragment)
M65® ELISA and the recently launched novel broad measuring range version
M65 EpiDeath® ELISA (both detect total cell death: Cytokeratin-18)
have been independently validated by pharmaceutical companies and clinical research centres for diagnostic use in oncology and hepatology.
In Germany CK18F /M30 is recognized as a useful serum biomarker to detect apoptotic (cryptic) liver injury, prominent in non-alcoholic hepatosteatosis (NASH), the severe manifestation of non-alcoholic fatty liver disease (NAFLD) especially in obese individuals linked to metabolic syndrome and diabetes.
M30-Apoptosense ELISA® is reimbursed by Health Care Insurers in Germany and recommended by the Government Health Authority, especially in children and adolescents, who are overweight or obese and therefore at higher risk for developing NASH, which can progress to liver cancer or end-stage liver disease, cirrhosis.
PEVIVA's quality assurance system is certified according to SS-EN ISO 9001 and SS-EN ISO 13485.
Clinicians and diagnostic laboratories in the UK interested in the determination of M30/CK18 at a BIOAXXESS® certified diagnostic partner laboratory on a fee-for-service basis, are invited to contact firstname.lastname@example.org.