Biomagnetics Diagnostics Corporation (OTC: BMGP) through its wholly owned subsidiary, Biospectrum Technologies holds patented technologies that can potentially revolutionize the stem cell, genetic engineering and biotechnology industries.
BMGP is developing a portfolio of patented technologies covering a wide range of bacterial and viral assays for use with the Company’s diagnostics systems. The Company was issued two patents relating to Systems and Methods for Biochemical Assay in 2003 and 2006, which allowed BMGP to protect its current technology and product offering and pave the way for a broad spectrum of applications in both testing and diagnosis. BMGP has also filed a third patent for a new diagnostic system designed for multi-analytic testing for blood banks (System and Method for Detecting Specific Binding Reactions Using Magnetic Label).
The first product being readied for market is the High Throughput Screening – Magnetic Testing Platform (HTS-MTP). This diagnostic equipment is designed to detect the target virus by measuring and defining a single paramagnetic microsphere attached to each virus molecule in a fraction of the time and cost of existing immuno assays.
It is important to note that the HTS-MTP is designed to detect both bacterial and viral pathogens as well as drugs of abuse using a medium of blood, serum, saliva, urine, hormonal or even spinal fluid. This is accomplished through the use of proprietary electronics, and chemistry which include specially designed sensors, which will detect paramagnetic-microspheres coated with specific antibodies, and will bind to any antigen (or other specified target) within the sample. Specific software programs will be designed for each type of pathogenic assay.
Additionally, no current screening, or confirmatory tests, have the ability to measure viral load; a critical measurement in developing drugs and vaccines and determining the effectiveness of health care treatments. The HTS-MTP is designed to detect the virus and count the viral load in a matter of minutes, and has the capabilities of screening many more assays per hour, at a fraction of the cost of current technology. This will revolutionize the diagnostics industry and be of significant importance to blood banks around the world.
Company management has identified certain immediacy in the Latin American and Asian markets. Therefore, initial Company efforts will focus upon conducting clinical trials and product registrations, not just in the United States but in Mexico, Thailand, China and Sweden (Sweden will register our products throughout Europe) as well. Upon completion of clinical trials in Latin America and Asia, the company will initiate a 510K registration with the U.S. Food and Drug Administration (F.D.A). In 2002, HIV diagnostics tests conducted in the US were 22.158 million and in 2002, Hepatitis B diagnostic tests in the US is estimated at 31 million.
Products
High Throughput Screening – Magnetic Testing Platform (HTS-MTP)
Biomagnetics Diagnostics Corp. has designed a revolutionary system of diagnostics. Our High Throughput Screening – Magnetic Testing Platform (HTS-MTP) is designed to detect both qualitative (chemical identification of the elements present in a substance) and quantitative (number of specific elements in a substance) results from a single test.
Today’s immunoassays (a chemical procedure for detecting infections) detect specific antibodies (blood proteins produced in response to and counteracting alien substances found in the body such as viruses and bacteria) but do not evaluate viral load (quantitative analysis), nor do they detect the antigen (the virus or bacteria itself). The HTS-MTP system utilizes technology that is simple in concept, but revolutionary in scope–allowing for the detection of the virus by “measuring” the magnetic field of micro-particles bonded to the virus in a fraction of the time and costs of existing assays. Most testing conducted in the United States today are screening assays (limited to the detection of antibodies), and are largely for detection purposes only. These tests are limited because they can only detect the presence of antibodies after a minimum infection time of two to six weeks. The Western Blot Test, the most widely used confirmatory test, again tests only for antibodies. The HTS-MTP system is designed to detect the virus (not the antibodies the human body produces to react to the virus) in a fraction of the time–72 to 96 hours. All with near 100% accuracy.
Using magnetism to detect to perform cost-effective and highly efficient viral load tests.
Pictured above (taken with an electronic microscope) are primary antibodies coated on the base of a testing receptacle, secondary antibodies coated on a magnetic particle, and the virus sandwiched between. This is one of the steps of our highly innovative HTS-MTP device.
According to S & P’s Industry Surveys, Biotechnology, December 29, 2005 revenues for all publicly traded biotech companies (US and non-US biotech-related concerns trading on major US stock markets) are expected to reach $50 billion in 2005. One of the largest medical products segments, in-vitro diagnostics accounted for about 18% of total industry sales, based on Health Industry Manufacturers Association (HIMA) estimates.
The Company defines its markets for the first line of products as public, private laboratories and blood banks. The world market size for manufacturing is $25 billion and the US retail market is $37 billion. The area of greatest growth in the in-vitro diagnostics market will be in the area of High Throughput Screening and Viral Load Detection, two areas in which our equipment and assays will excel.
The initial markets for the Company’s products will be Mexico and Thailand. Over the past 20 years management has developed key government relationships in these countries. Both countries conduct millions of HIV and Hepatitis B tests annually.
Upon completion of clinical trial Latin America and Asia, the company will initiate a 510 K Registration with the U.S. Food and Drug Administration (F.D.A.). In 2002, HIV diagnostics tests conducted in the US was 22.15 million and in 2002, Hepatitis B diagnostic tests in the US were estimated at 31 million.
Multi-Analytes
The Company has filed for a third patent relating to a multi-analyte immunoassay specifically designed for use by blood bank centers.
According to an article in the Medical Laboratory Observer, August 2000 (latest data available) Blood bank Centers of California, which represents 18 blood banks that handle 80 percent of the state’s blood supply, reports total losses of nearly $33 million in three years. To help recoup some of the increased costs, the nonprofit Sacramento (with losses of $3 million over the same time period) Blood Center, which operates on a $35 million budget, has raised its price on a unit of blood twice in the past year. Although it now charges $100 per unit, the center spends about $105 per unit to collect, analyze and deliver the blood to users.
The center has equipment that can detect HIV and hepatitis B before the deadly viruses show up in normal blood tests. Use of the equipment to screen for hepatitis B has added $8 to the cost of a unit of blood; use of the equipment to
Biomagnetics has designed a system that can test for all eight viruses, currently being screened for in each unit of blood, in a single assay, thus greatly reducing the cost to analyze incoming blood.
Nationally, blood banks screen 14 million units of blood annually for seven types of viruses for a total of 91 million tests per year.
