QuantRx Biomedical's developments in genetics-based technology

Jan 20 2010

QuantRx® Biomedical Corporation (OTCBB: QTXB), a broad-based diagnostic company focused on the development and commercialization of innovative diagnostic products, today provided an update from Chairman and Chief Executive Officer Walter Witoshkin on its involvement in genetics-based personalized medicine and disease prevention.

“Methods and devices based upon a novel form of the nucleic acid duplex on a surface.”

The commentary below is attributable to Mr. Witoshkin and is followed by a review of significant developments in 2009 for genetics-based technology from QuantRx affiliate company Genomics USA.

“QuantRx is focused on identifying and developing diagnostic technologies that exploit paradigm shifts in modern healthcare practices. Among our platform technologies, we are working on several exciting opportunities that are being developed for commercialization and licensing. Our first platform, addressing a multi-billion dollar market, combines our new flagship point-of-care diagnostic reader device, Q-Reader™, with our proprietary lateral flow technology. This product is expected to begin generating sales later this year. Until recently, Genomics USA was thought to be developing a distant second platform, which is technology used for genetics-based personalized medicine and disease prevention. However, given the progress and achievements for this technology in 2009, we are optimistic that this product may be launched far earlier than initially anticipated.

“With significant U.S. government agency funding awarded in 2009 and additional support from QuantRx, Genomics USA continues to develop an innovative process that utilizes human genome identification for personalized medicine. This product platform targeting the new and rapidly growing market for personalized medicine uses information about a person’s genetic make-up to tailor strategies for the detection, treatment or prevention of disease as well as a host of gene therapy and stem cell transplantation applications.

“The foundation of this platform is Genomics USA’s patented microarray technology. In 2009 considerable progress was made in strengthening the intellectual property on this product. Microarray technology resides on a one-square-centimeter silicon chip that contains up to a thousand DNA probes that identify specific human gene sequences of diagnostic interest. With this leading-edge technology, QuantRx, through Genomics USA, is in the forefront of the laboratory-based testing market with new technology to allow microarrays to be used as a cost-effective diagnostic or population scale screening test.

“Microarray technology is being developed for population-scale typing of HLA – the human leukocyte antigen, a segment of the genome that is essentially the core of the human immune response. HLA is composed of proteins that play a critical role in activating the body’s immune system to respond to foreign organisms. Typing HLA results in the ability to detect a majority of disorders related to the immune system. The ability of an individual to respond to a particular vaccine is also determined by his or her HLA type. An initial application for this HLA-based technology is in vaccine development and personalized vaccine delivery. Genomics USA is actively engaged in obtaining key certification, which we believe will aid in receiving U.S. Food and Drug Administration approval.

“The healthcare community is presently embracing what has been described as the dawning of a new era of personalized medicine driven by advances in genome research. As we plan our product development and investments for 2010 and beyond, we are especially pleased with the outlook for our genetics-based disease prevention platform that should see microarray technology move into the forefront.”

Significant Developments for Genomics USA in 2009

November 2009 -- Genomics USA presented its HLA-Chip technology at the national meeting of The American Society of Histocompatibility and Immunogenetics (ASHI). This appearance was a springboard event for Genomics USA to obtain ASHI certification of its HLA-Chip technology. The Company now believes this certification may be obtained in the fourth quarter of 2010. ASHI certification will strengthen the intended application and approval by the U.S. Food and Drug Administration for the HLA-Chip product by 2012. The HLA-Chip product consists of gene probes for the analysis of genetic compatibility in marrow, stem cell & solid organ transplantation: the well-known backbone of transplantation medicine.

October 2009 -- The U.S. Patent and Trademark Office notified Genomics USA of a Notice of Allowance to Issue a Patent on “Population Scale HLA Typing and its Uses Thereof.”

September 2009 -- Genomics USA received a prestigious three-year, $3 million Phase II Continuation SBIR award from the National Institutes of Allergy & Infectious Disease. This award funds FDA review of the HLA-Chip for analysis of genetic compatibility in marrow, stem cell & solid organ transplantation. The work entails collaboration with three expert labs within the organ and stem cell transplantation community and will provide late-stage commercialization support into that rapidly growing specialty of laboratory medicine.

September 2009 -- Genomics USA received a two-year, $600,000 Phase I Advanced Technology SBIR award from the National Institutes of Allergy & Infectious Disease. This funds development of a variant of the HLA-Chip, referred to as the “AIDS-Chip” for population-scale screening of personal variation in the sensitivity to HIV infection and, more broadly, to infection and inflammatory diseases of other kinds, such as Ciliac Disease and certain types of arthritis, via personalized variation in the immune response.

April 2009 -- The U.S. Patent and Trademark Office awarded Genomics USA the U.S. Patent 7,354,710, "Methods and devices based upon a novel form of the nucleic acid duplex on a surface." This patent comprises an important base for the Genomics USA technology platform.