Projects Profile
Project Title
Establishment of a novel immunological assay to distinguish patients with autoimmune hepatitis from those induced by hepatitis B virus infection
Partnership
Dr Yun Ma and Prof Diego Vergani, King’s College London
Prof Huifeng Wang and Prof Jinhua Hu, Chinese Military General Hospital for Infectious Diseases
Project Aim
In this project, experts from King’s College London and Chinese Military General Hospital for Infectious Diseases are partnering up to develop jointly a novel diagnostic assay technology with high diagnostic rate on autoimmune hepatitis and will be able to differentiate AIH with hepatitis B infection.
This project draws on the complementary expertise from King’s and CGMID on AIH diagnosis and bioassay development to transform the knowledge on AIH diagnosis and treatment into a clinical applicable testing technology to address the unmet medical need for AIH diagnosis technology.
Inspiration for the projects
Autoimmune hepatitis (AIH) is a severe form of liver disorder. Without treatment, nearly 50% of patients will die in about five years. The incidence of AIH has increased six-fold over the past 10 years at King’s College Hospital, London, the largest UK tertiary referral centre. Incidence of AIH has also increased sharply in China in recent years. Amongst several diagnostic autoantibodies for AIH, anti-soluble liver antigen (SLA) antibody is the only one with high specificity for the disease. Importantly, anti-SLA antibodies are absent in patients with hepatitis B virus infection and thus provide for an important diagnostic target to distinguish AIH patients from those with HBV infection in China, where such liver
diseases are endemic, and thus allow for timely administration of appropriate immunosuppressive treatment.
Present commercially available ELISA or Immunoblot diagnostic assays have low sensitivity and only detect anti-SLA antibodies in 10% to 20% of AIH patients. Therefore, diagnosis technology for autoimmune hepatitis (AIH) with hepatitis B infected patents is still an unmet medical need requesting addressing urgently.
Recently a radioligand assay which detects 50% of patients with AIH was developed by Dr Ma at King’s College London. There is now an urgent need to establish a novel non-isotopic immunoassay, namely enzyme-linked immunosorbent assay (ELISA), with equal high sensitivity to the radioligand assay. Meanwhile Chinese Military General Hospital for Infectious Diseases (CMHID) has also devoted huge effort in diagnosis assay technology development in this disease area and built up a strength expertise in biological reagents handling and assay kit development. Development of a commercial diagnostics assays has great potential to be used as a routine test for diagnostic of AIH both in the UK and in China where population with hepatitis infections representing well over half of that in the whole world. The establishment of such an assay will have an enormous social impact in terms of improving quality of health care both in UK and China.
Commercial Potential and Further Development
The project will establish a joint research team with strong complimentary expertise in AIH and hepatitis B diseases and their diagnosis and treatment, and assay development. The joint team will produce a
commercial demonstration of an AIH diagnostic bioassay technology suitable for clinical use with high diagnostic rate. The market needs, technology feasibility, competitive advantages and commercialization routes will also be assessed.
The project may well lead to open up new opportunities for novel AIH diagnostic assay development and commercialization, and has attracted has attracted significant industry interests. Numerous companies have expressed strong interests in gaining access to the technology upon the project completion and willingness in future commercialization cooperation.
