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Nanotechnology and Medicine

Often hailed as a revolutionary new technology, nanotechnology has the potential to impact almost every area of society. Nanotechnology involves manipulating properties and structures at the nanoscale, often involving dimensions that are just tiny fractions of the width of a human hair. Nanotechnology is already being used in products in its passive form, such as cosmetics and sunscreens, and it is expected that in the coming decades, new phases of products, such as better batteries and improved electronics equipment, will be developed and have far-reaching implications.

Nanotechnology medical developments over the coming years will have a wide variety of uses and could potentially save a great number of lives. Nanotechnology is already moving from being used in passive structures to active structures, through more targeted drug therapies or “smart drugs.” These new drug therapies have already been shown to cause fewer side effects and be more effective than traditional therapies. In the future, nanotechnology will also aid in the formation of molecular systems that may be strikingly similar to living systems. These molecular structures could be the basis for the regeneration or replacement of body parts that are currently lost to infection, accident, or disease. These predictions for the future have great significance not only in encouraging nanotechnology research and development but also in determining a means of oversight. The number of products approaching the FDA approval and review process is likely to grow as time moves forward and as new nanotechnology medical applications are developed.

Bimolecular detection is based on the biochemical reaction between probes labeled with traditional signal reporting system, e.g. radioactive, fluorescent or chemical luminescent materials, and the samples. Those traditional signal reporting systems all have different shortcomings to some extent, which make the development of home-applicable end-user diagnostic test paper and portable diagnostic devices very difficult to realize from the technical stand of view. However, as a disruptive technology, the emergence of gold nanoparticle as the novel signal reporting system is changing the above scenario, giving a very promising future to realize those home-applicable diagnostic reagents and devices. Combining gold nanoparticle and silver signal enhancement method, a visible detection results by the eye will be generated to indicate the presence of specific pathogens or other target molecules. This technology is 100 times more sensitive than conventional methods, with the ability to detect as few as 60 DNA molecules without the need for target amplification using methods such as Polymerase Chain Reaction (PCR). With regards to the detection of protein, this technology enables the detection of as low as pg (10-12g) level for pathogen-related antibody/antigen detection.

The core technology of Abgenom is its proprietary Nano-amplification technology and its application in integrated diagnostic bio-chip to be used for bimolecular detection to provide a hyper-sensitive and low cost innovative application platform, particularly for the areas of our focus: cardiovascular diseases and various infectious diseases / zoonoses. Our proprietary technologies and extensive experiences in antibody (pairs) development are the keys to successfully develop the rapid immuno-test device. The antibody pairs are the most impotent components for in vitro clinical diagnostic reagent/kits based upon Antibody-Antigen immunoassay.

Members of our management team have been actively involved in the development and optimization of those technology platforms in US, Japan and China. Fifteen patents have been filed worldwide. Among those, six patents have been issued and nine others have been filed and submitted for further processing.

Areas of Focus: Cardiovascular and Infectious Diseases / Zoonoses

Cardiovascular disease is the single largest killer in the United States. With nearly one million deaths caused by cardiovascular disease each year, stroke and coronary heart disease (CHD) account for more than seventy percent of these fatalities. Cardiovascular disease is the leading cause of death and disability, with approximately 500,000 fatal heart attacks and 700,000 strokes per year in the United States alone. More than 15 million Americans have a history of coronary heart disease. This year, an estimated 300,000 Americans will have a recurrent heart attack. The prevalence of coronary heart disease also contributes to burdensome healthcare costs for patients as well as the nation's healthcare system. The American Heart Association expects direct and indirect costs of coronary heart disease to total nearly $152 billion in 2007.

The company has developed two diagnostic kits or rapid test devices for cardiovascular diseases, and now they are being prepared to apply clinical trial both in China and US. The first product in our products pipeline is a rapid test device for early diagnosis of acute myocardial infarction (AMI). (Another product is a test kits for diagnosis of hypertriglyceridemia).

The best time frame to treat AMI is within the first 3 hours when AMI is identified. However, most treatments of AMI are delayed due to the limitation of diagnostic tools, poor facility of small community and rural hospitals in China, and patients’ poor self-protect consciousness. Our product is designed to solve those problems. With tremendous study and initial strict confirmative clinical trial, three myocardial markers (one with high specificity to AMI, two with high sensitivity for very early AMI) were selected as antigens to develop corresponding monoclonal antibody (pairs) for capturing and detecting the antigens (myocardial markers). Combining with the nano-colloidal gold immuno-chromatographic assay techniques, a new one-step rapid test device for early diagnosis of AMI were successfully developed. It is specific, sensitive, simple and fast with no requirement for any special equipment and apparatus, which, therefore, provides AMI patients with an efficient, convenient and inexpensive tool to self test at home, quick check in emergency room, as well as fast screening test in community or rural hospitals.

Abgenom has an advantage in the development of various rapid diagnostic devices and integrated diagnostic chips for cardiovascular diseases and infectious diseases because of the breadth of our intellectual property. We currently possess in-house proprietary rights to 15 patents covering different technology platforms and their applications, i.e. nano-colloidal gold technologies for developing rapid test devices; Real-time qPCR for rapid detecting various pathogens simultaneously; and integrated diagnostic chips to simultaneously detect various pathogens, virus and antibodies. As regard to applications, our patents cover different groups of diseases such as cardiovascular disease, STD, virus hepatitis, and multiple HIV antibodies. Abgenom can use a panel of antibodies/antigens to detect infectious disease in patients instead of relying on just one single antibody/antigen and also develop several panels that cover different groups of infectious diseases / zoonoses. By using a properly selected panel in our test systems, we believe our test systems’ reliability will be superior to a single pathogen/marker test.


 
 

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