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We are proud to announce our newest in-vitro diagnostic product, HCC-REAAD™, a immunoassay for Hepatocellular Carcinoma. Find out more below and in the products page or contact us for more information.

A press release was made for the product. See the full press release here.

Singapore’s Restalyst develops more effective test kit for liver cancer

11th November 2016, Singapore Singapore biomedical firm Restalyst, known for its fuss-free test kits for stomach and nasopharyngeal carcinoma, has come up with a similar product to detect liver carcinoma. Hepatocellular carcinoma (HCC), the most common form of liver carcinoma, is among the top four killer carcinomas in Singapore and causes up to one million deaths globally every year.

It typically occurs in people infected with the Hepatitis B and C viruses, but can also come about when the liver is damaged by too much alcohol. While experts previously believed that this carcinoma was prevalent only in South-east Asia and Africa, the rapidly increasing number of cases in Europe and the United States has shown otherwise. There is a growing need for tools that can help doctors detect and treat HCC early.

To address this problem, Restalyst has developed a patented screening kit to detect if a person has liver carcinoma. The test, called the Hepatocellular Carcinoma Recombinant Antigen-Antibody Detection kit (HCC-REAAD™), works by employing an ELISA[1] test that uses antibodies to target a specific biomarker. When a person has HCC, the concentration of this biomarker in their blood elevates[2]. By being able to detect this biomarker, which is known as IGFBP2[s1] , the HCC-REAAD™ test can detect whether a person has liver carcinoma. The HCC-REAAD kit was developed based on a patented technology by Professor Hsieh Sen Yung from Chang Gung Memorial Hospital in Taiwan.

“The conventional method of detecting liver carcinoma is not good enough and many cases are picked up too late. By developing in-vitro diagnostics like HCC-REAAD™, which has a high sensitivity and specificity, we hope that more cases will be found at an earlier stage. At Restalyst, we believe in developing diagnostics to improve the efficacy of diagnosis so as to allow for earlier detection, treatment and indirectly saving lives,” said Mr Zaccheus Peh, CEO of Restalyst.

In Singapore, liver carcinoma is among the top four killer carcinomas for both men and women, and caused 2,514 deaths between 2010 and 2014.[3] While there have been other attempts to create test kits for liver carcinoma, many use a different biomarker known as alpha-fetoprotein (AFP). However, using this protein to test for carcinoma has not been without controversy.[4] People who have HCC have been found to have low levels of AFP in their blood. And other people who did not have carcinoma, but had other liver problems such as cirrhosis, were tested to have high levels of AFP. This makes AFP of limited use for doctors who are trying to ascertain whether or not a person really has liver carcinoma. In fact, the use of AFP is not recommended by three large associations in the United States and Europe that study liver carcinoma; it is only used in Japan.[5]

In contrast, Restalyst’s HCC-REAAD™ is able to identify those with liver carcinoma to a high degree of accuracy because it makes use of the unique IGFBP2 biomarker[s2] . Studies have shown that the HCC-REAAD™ test has sensitivity and specificity of 82 and 91[s3]  per cent respectively. It only requires minute amount of a person’s blood to run the test, and takes about two hours to complete. The HCC-REAAD™ kit has already received CE Mark certification to be used as an in vitro diagnostic device in the European Union. It will be launched at MEDICA 2016, the largest medical trade fair in the world, from 14 to 17 November in Germany. Restalyst will be participating at Booth 74, Hall 3, as part of the Singapore Pavilion.

[1] Enzyme-linked immunosorbent assay. This is a technique used to measure the concentration of a specific substance in a blood sample.

[2] Patent; Protein markers for detecting liver cancer and method for identifying the markers thereof

[3] Singapore Carcinoma Registry. Trends on Carcinoma Incidence in Singapore, 2010-2014. National Registry of Diseases Office

[4] Asrih M, Lenglet S, Mach F & Montecucco F. (2013). Alpha-fetoprotein: A controversial prognostic biomarker for small hepatocellular carcinoma. World J Gastroenterol. 19(3):328-330.

[5] Japan Society of Hepatology. (2015). Clinical Practice Guidelines for Hepatocellular Carcinoma Differ between Japan, United States, and Europe. Liver Carcinoma. 4(2):85-95.