The Diagnostics Development Unit (DDU) was established almost a decade ago by a group of industry scientists who worked at a multinational diagnostic company.

The goal of the unit is to develop innovative tests that are rapid, simple, cost-effective and more sensitive than currently available rapid tests. This new generation of point-of-care tests are intended for the detection of infectious agents that cause serious health problems in resource-limited settings, particularly in developing countries, while remaining useful and desirable in point of care settings in the developed world.

The DDU team has extensive experience in multiple disciplines such as nucleic acid chemistry, microbiology, molecular biology, monoclonal antibody production, material sciences, and the regulatory affairs necessary for product development.

Technologies under development include sample extraction and rapid and sensitive detection of infectious disease targets (DNA, RNA, antigen or antibodies). The team has developed two technology platforms, SAS (Signal Amplified System) for protein targets and SAMBA (Simple amplification based assay) for nucleic acids.

Picture of Dr Helen Lee in the laboratorySAS is based on multiplying a visual signal via an increase in the valency and size of the coloured immune complex in the assay, by chemically coupling multiple copies of a hapten to the primary detection antibodies. The resulting lattice formed between the analyte, multiple hapten-labelled antibody and the anti-hapten colour conjugate yields a strong visual signal.

SAMBA is a sensitive, visual, point-of-care nucleic acid-based platform for the qualitative or semi-quantitative detection of analytes such as HIV RNA or influenza in plasma samples, for use as an aid in the diagnosis and monitoring of HIV infection, especially in babies, and anti-retroviral therapy monitoring.

To date, the team has developed a Chlamydia rapid test on the SAS platform using non-invasive and easy-to-collect specimens. This product has received the CE mark from the European Union authorities and is made available from DDU’s spinout company, Diagnostics for the Real World (Europe) Ltd, Cambridge, UK, who are collaborating with NGOs such as MSF to apply and distribute the test in developed and developing settings.

Subsequent products in the pipeline based on the same SAS technology for Chlamydia Rapid Test include a dual test for simultaneous detection of gonorrhoea and chlamydia and individual tests for HIV, hepatitis B and C viruses. The SAMBA platform will also be used for developing a rapid test for influenza subtype testing and for qualitative and semi-quantitative detection of HIV-1 RNA across multiple subtypes.

Awards

The products and technologies developed by DDU scientists received the Medical Futures Innovation Award (UK) for its innovative sample collection device and more recently, the 2007 Tech Museum Innovation Award (US) for innovation in the Health Category, in recognition of the Signal Amplification technology, which greatly improves the sensitivity of rapid test for the detection of infectious diseases. (see video interview) (hear audio interview)

The unit has filed 12 families of patent applications, with 20 granted or allowed national patents, detailing inventions that improve the performance of rapid diagnostic tests.