System substitutes for biopsy by using surrogate markers of liver disease that can be measured using simple blood tests
Lab21 has announced the availability of a new, easily accessible clinical testing service that uses the groundbreaking FibroTest-ActiTest system, a non-invasive testing package, for the assessment of liver fibrosis and active liver disease.
The new service has been added to the Lab21 portfolio following the company's recent acquisition of Oneida Theradiagnostics, which previously provided testing for the UK and Ireland.
Liver biopsy is established as the gold standard to evaluate the status of the liver, but it is an invasive, potentially dangerous and costly procedure that can only be performed at infrequent intervals, so is unsatisfactory for careful monitoring of liver disease.
The new system substitutes for biopsy by using surrogate markers of liver disease that can be measured using simple blood tests.
Developed by leading hepatologists at the Pitie-Salpetriere Hospital and BioPredictive in France, FibroTest-ActiTest was first validated for use with hepatitis C patients.
It is now available in many parts of the world.
More than 80,000 HCV patients are currently being clinically managed using the system.
In addition to its value in HCV disease, the test has now also been clinically validated for HBV, alcoholic hepatitis and non-alcoholic fatty liver disease (NAFLD)/non-alcoholic steatohepatitis (Nash).
A combination of six serum biochemical markers, plus age and gender data and a patented algorithm determine the degree of liver fibrosis and the level of ongoing necroinflammatory activity.
Result correlate directly with international numerical standards (Metavir score).
Berwyn Clarke, chief scientific officer of Lab21, commented: "Using the new Lab21 service is very straightforward.
"Standard blood samples are collected and processed.
"The results are analysed using the proprietary algorithm, interpreted and returned to the physician with a full report in a very short time".
The accuracy of FibroTest-ActiTest is such that it is widely considered a valid alternative to liver biopsy as a first-line tool, or otherwise as an extremely useful supplement to liver biopsy to enable improved management of chronic liver disease.
Clarke says: "By using FibroTest-ActiTest, many patients will be spared the trauma and risks associated with biopsy".
There will also be considerable savings in terms of cost.
Lab21 says it has a vision of how technically advanced clinical testing services support the pharmaceutical industry and healthcare providers as we move towards personalised medicine, and how monitoring pollutants and toxins in the environment helps minimise their damaging impact on our health.
Delivering clinical insight, rather than exclusively developing its own technology, as many diagnostic companies do, Lab21 is assembling best-in-class tests and technology platforms from specialist partners around the world.
It sayts it adds a high level of expertise and know-how to deliver antiviral drug discovery services plus a portfolio of cutting-edge molecular diagnostics, viral characterisation, pharmacogenetic tests, and patient profiling.
