With Universal Biosensors' (UBI) electrochemical
strip technology already demonstrated in blood glucose and coagulation testing,
the company is focused on adding new clinically relevant and commercially
attractive tests to its product pipeline. UBI is developing an
immunoassay-based biosensor (an important technique for biomarker measurement),
which is progressing through the feasibility stage of the company's R&D
pipeline. Another key opportunity is UBI's early but exciting research
into molecular diagnostics testing.
The immunoassay is an important
technique for biomarker measurement. Immunoassays account for approximately 20%
of the ~US$50 billion per annum in vitro diagnostics market and many of these
assays could easily be transferred to the fast growing point-of-care segment if
a more appropriate technology existed.
UBI's vision in
this area is to develop a single analyser platform that can utilise multiple
biosensors to analyse a wide array of biomarkers using immunoassay techniques.
An example of an immunoassay based test that UBI has
incorporated in its research program is the D-Dimer test. Conditions which are
associated with high D-dimer levels include deep venous thrombosis (clots in
the leg) and pulmonary embolism (clots in the lung). PE and DVT, collectively
referred to as venous thromboembolism (VTE), affect up to 3 million patients
annually and kill up to 200,000 of them, more than breast cancer and HIV
combined. However, up to 75% of patients with suspected VTE do not actually
have the disease. A negative D-dimer test enables the safe and immediate rule
out of VTE in suspected cases, preventing unnecessary and costly additional
In addition to D-dimer, other immunoassay targets that are experiencing
significant growth include cardiac markers and oncology markers. With a truly
universal immunoassay test, UBI will have the opportunity to
expand into a broad range of growing markets.
Molecular Diagnostics tests are a new wave of cutting edge technology that analyse genetic information. In particular, the tests look for genetic mutation or levels of certain genetic material (that uniquely identify a cancer or virus, for example), which may affect the probability of developing a disease, aid in the diagnosis of a disease or infection, or improve the response to treatment.
The market for molecular diagnostics is a broad segment, including blood screening, infectious disease testing, genetic testing and oncology testing. Molecular diagnostics also has the ability to drive new approaches to therapy, by enabling doctors to tailor their therapeutic strategy for each individual based on genetic information.
The market for molecular diagnostics is valued today at more than US$5 billion worldwide and is expected to grow at more than 12% annually. UBI anticipates continued growth in this area due to:
- An ageing population and greater incidence of chronic disease;
- A need for earlier diagnosis and faster treatment to reduce healthcare costs;
- An improved understanding of human genetic makeup (and how to identify irregularities); and
- Advances in chemistry and instrumentation technology.
UBI has signed a non-exclusive licence agreement with Australian company, SpeeDx Pty Ltd, for access to its proprietary MNAzyme technology, which is a highly selective method for detecting sequences of RNA and DNA.
UBI hopes to combine these MNAzymes with UBI's proven biosensor technologies to detect DNA or RNA electrochemically, meaning:
- Tests would take minutes, rather than the hours typically required for molecular tests today; and
- The system would be simple to use and cost effective.
UBI's vision is to make true, rapid and convenient, point-of-care DNA and RNA testing possible.