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Can Perspectum Diagnostics' LiverMultiScan replace painful, expensive liver biopsies?

por Lauren Dubinsky, Senior Reporter | April 13, 2016
European News Medical Devices MRI X-Ray
Courtesy of
Perspectum Diagnostics
Patients with liver disease usually have to undergo needle biopsies, which can be painful and expensive, but a noninvasive option that uses MR may replace that. A multimillion-Euro grant was recently awarded to a consortium of hospitals to use Perspectum Diagnostics' LiverMultiScan instead of biopsies.

In Europe and the U.K., non-alcoholic fatty liver disease (NAFLD) has become the most commonly diagnosed cause of chronic liver disease, according to a study published in Deutsches Arzteblatt International. Obesity is one of the major risk factors that contribute to NAFLD and the World Health Organization predicted that in 2015 the number of obese people in the world would rise to 700 million.

The LiverMultiScan imaging device was approved by the FDA in November 2015 and was formally launched at the 2015 American Association for the Study of Liver Disease meeting. It was first introduced in Europe and the U.S. as a research device in 2014 and is now installed in leading medical centers across three continents.
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The device uses quantitative MR methods, similar to what is used in cancer and cardiac imaging. After a 15-minute MR exam, it generates a highly detailed map of the whole liver so clinicians can accurately identify the regions of disease.

The analysis that the device conducts is based on the assessment of native properties of liver tissue, accurate measurement of liver fat and other metrics, without requiring additional diagnostic technologies or contrast agents.

As many as six patients can be tested per hour using the LiverMultiScan, with a 95 to 97 percent success rate, according to the company.

The Rapid Assessment and Diagnosis in Chronic Adult Liver disease (RADiCAL) trial will investigate the cost of care associated with using liver biopsy compared to using LiverMultiScan. For the trial, 2,000 patients who are suspected to have NAFLD will be recruited to centers in Germany, the Netherlands and Portugal.

The patients will randomly be selected to be in a group that has them undergo biopsy or a group that uses LiverMultiScan to determine the presence and extent of the disease. After that, the cost-effectiveness and patient-reported outcomes of both groups will be compared.

"There is a real opportunity here, not only to make significant economic savings at a time when all health services are under pressure, but also to reduce the number of patients having to undergo what can be a stressful and painful procedure," Dr. Rajarshi Banerjee, CEO of Perspectum Diagnostics, said in a statement.

Horizon 2020, the biggest European research and innovation program with almost €80 billion of funding available over 7 years, will be funding the trial.

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