QUANTRX BIOMEDICAL CORP (QTXB) - Description of business
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QuantRx is a biomedical company that is committed to the research, development, acquisition and commercialization of medical diagnostic products. Whether directly or in collaboration with other commercial partners, QuantRx creates and brings to market proprietary medical technology platforms and products for diagnostics and treatment of medical and healthcare needs.
With significant core intellectual property, QuantRx is developing diagnostic platforms and products for professional, industrial and consumer use that will be commercialized and marketed through partners or distributors with manufacturing contracted to third parties even as QuantRx maintains control of the development and manufacturing processes.
The Company's technology platforms include the following:
o Rapid point-of-care testing products based on lateral flow diagnostic devices that make medical information directly available to the healthcare provider or the patient.
o QuantRx PAD technology that provides the basis of a variety of diagnostic and treatment products that address consumer health issues.
o Diagnostic molecular imaging products for use in the PET - positron emission tomography - market.
o Clinically optimized genome-based diagnostic microarray chips with an initial focus on detecting immune system-related disorders.
QuantRx combines its intellectual property with an understanding of applications for medical diagnostics and treatment; the result is a pipeline of new products for the professional, institutional and over-the-counter markets.
The QuantRx staff of scientists and medical experts and the Company's business-leadership team, made up of biomedical and healthcare industry professionals, are dedicated to bringing to market innovative diagnostic platforms and products.
Product and Product Candidates
QuantRx operates under a two-fold product development strategy: (1) Maximization of the value of internally developed products that are market-ready for near-term distribution, and (2) Aggressive development of technology platforms for products that QuantRx believes will address medical diagnostic and treatment problems into the future.
In order to capitalize on short-term revenue opportunities, QuantRx - in introducing its lateral flow diagnostic devices, Miniform PAD product lines and other products - aligns itself with experienced marketing partners that have established distribution channels. QuantRx teams with a manufacturing partner in Asia, as well as niche U.S. manufacturers, in order to bring products to market more quickly and at lower cost while controlling product quality. Distribution of our lateral flow diagnostic and Miniform PAD products is expected to commence in 2007.
FluoroPharma, Inc., a private company in which QuantRx has a significant ownership interest, continues clinical trials in the development of next-generation imaging agents for PET - positron emission tomography - diagnostics with initial indications for cardiovascular disease. Genomics USA, Inc., another company in which QuantRx has invested, is working toward completion of its HLA - human leukocyte antigen - chip technology for vaccine validity testing and initiation of field tests with the U.S. Department of Homeland Security.
The QuantRx internal development efforts are in parallel with the Company's investigation of technologies and products for acquisition or licensing to help the Company expand and enhance its current platforms and succeed in its mission to be a market leader in medical diagnostic platforms and products for professionals, industry and consumers.
Lateral Flow Diagnostics
QuantRx has developed a patented RapidSense(R) technology - a one-step lateral flow test with unique features such as: positive read indication for Drugs of Abuse, improved sensitivity, and the ability to read both large and small molecules. The rapid, disposable and point-of-care diagnostic technology is ideal for collection of either urine or oral fluids.
QuantRx also has a patented technology based on an innovative oral fluid collection device specifically designed for lateral flow tests - the only one-step oral fluid testing device now on the market developed by QuantRx for use with its patented RapidSense technology. This distinctive collection device has applications in the growing market of oral sample collections for issues ranging from drug-abuse testing, gathering biological evidence for criminal investigation, screening for numerous communicable diseases including HIV/AIDS and other STDs.
The QuantRx device - an industry first - incorporates a removable barrier that prevents test chemicals from washing into the oral cavity during the collection process, and allows the controlled start of the test or tests within the device. Because the QuantRx device is designed for either a single test or multiple tests using the same sample, it is ideal for emerging drugs of abuse analyses and testing for a range of communicable diseases. The patented technology has a feature that provides a more secure "chain of custody" system, helping to ensure the identity and integrity of a specimen from collection through the reporting of test results.
QuantRx is in the process of filing for clearance from the U.S. Food and Drug Administration ("FDA") to market several tests for drugs of abuse as well as a test for FSH - follicle stimulating hormone. QuantRx plans to expand its 510(k) portfolio as well as new intellectual property.
The technology has strong potential and numerous possible applications. For this reason, QuantRx is pursuing collaborative research-and-development and OEM relationships with companies and organizations interested in exploring new and existing analytes to drive the development of new products for the diagnostic marketplace to advance healthcare worldwide.
Miniform PADs for Diagnosis and Treatment
The Miniform PAD is a QuantRx-patented technology that provides the basis for a line of products that address an array of consumer health issues including: temporary relief of hemorrhoid discomfort, feminine incontinence, drug delivery and medical sample collection for diagnostic testing.
The QuantRx Miniform PAD is fully biodegradable and flushable, making it convenient and easy to use, and naturopathic, addressing the growing trend in medicine to turn to products that seek to improve health and treat disease chiefly by assisting the body's innate capacity to recover from illness and injury.
The Company plans to market its initial PAD-based products, scheduled for introduction in 2007, under the QuantRx Unique(R) and QuantRx inSync(R) brands through various distribution arrangements. Addressing the over-the-counter market for hemorrhoid pain relief medication and supplies, QuantRx Unique incorporates technology licensed from the Procter & Gamble Company. The proprietary Unique, the only product intended for daily hemorrhoid treatment, is distinctive in that it is the only PAD-based hemorrhoid-treatment product in a segment of the healthcare market that has experienced little or no innovation in decades.
The QuantRx inSync Miniforms - treated and untreated - are over-the-counter feminine incontinence products, an alternative to pads and liners for light flow urine incontinence, or daily feminine hygiene needs.
The Company plans to introduce products for both the catamenial and hemorrhoid over-the-counter market segments in 2007. In addition, QuantRx intends to clinically validate the use of its PAD technology as an over-the-counter homeopathic therapy for yeast infections. It also may have application in therapeutic transdermal drug delivery, based on results of preclinical vaginal drug-delivery research conducted at the University of Belfast.
QuantRx PadKit(R) was developed on the basis of clinical research indicating that the Miniform may also be an ideal diagnostic sample collection device. When coupled with a simple transport kit, it allows patients to take their own samples which are sent to a laboratory for analysis and diagnosis as well as screening for drug use, genetic conditions and disease. QuantRx holds several patents covering this application and plans to commercialize products it may develop under this patent under the QuantRx PadKit trademark. Commercialization requires extensive clinical testing prior to submission to the FDA for marketing approval.
The Company is exploring the potential combination of the Miniform PAD sample-collection capability with the microarray technology of its affiliate company, Genomics USA, to bring to market a diagnostic tool for female tissue sampling, specifically testing for colon cancer and HPV, or human papillomavirus, a virus that causes cervical cancer.
Molecular Diagnostic Imaging
FluoroPharma, a private company in which QuantRx has a significant ownership interest, is developing proprietary molecular diagnostic imaging products for use in the PET - positron emission tomography - market. Initial focus is the development of novel PET imaging agents - CardioPET, BFPET and VasoPET - for efficient detection and assessment of acute and chronic forms of coronary artery disease with additional application in the broader cardiovascular, oncology and neurology arenas. The agents rapidly target either the myocardial cells within the heart or the vulnerable plaque within the coronary arteries and, combined with PET scanning, provide non-invasive, highly specific and efficient assessment of heart metabolism and physiology.
CardioPET, one of the first metabolic imaging agents available for PET, allows acute and chronic coronary artery disease to be assessed while patients are at rest, of vital importance for those who cannot undergo the exertion of a standard treadmill stress test. Following filing of an Investigational New Drug application with the FDA, CardioPET Phase I clinical trials were undertaken and completed in early 2007. Additional uses for CardioPET include emergency room evaluation of chest pain, detection of damaged myocardium and identification of patients who may benefit from angioplasty.
BFPET is a sensitive marker of cardiac ischemia, a condition in which blood flow to the heart muscle, and thus oxygen, is restricted. BFPET, a novel cardiovascular blood flow imaging agent, has proven ability to detect ischemia in experimental models.
VasoPET is the only PET agent to selectively target inflamed or vulnerable atherosclerotic plaque without the need of a standard stress test. With VasoPET, physicians identify dangerous coronary artery plaque in patients with coronary artery disease or carotid artery disease.
Phase I clinical trials for both BFPET and VasoPET are expected to commence in 2007.
Genome-based Diagnostic Microarray Chips
Forming the basis of next-generation point-of-care diagnostic technology is the clinically optimized microarray technology of the QuantRx affiliate company Genomics USA. Population-scale typing of HLA - human leukocyte antigen, a substrate of the genome - is the initial focus, resulting in the ability to detect disorders related to the immune system.
An initial application for this HLA-based "laboratory on a chip" is in vaccine development and personalized vaccine delivery, essentially determining a vaccine's effectiveness for a particular individual. Additional applications include tissue transplantation, stem cell therapeutics and personalized treatment for autoimmune diseases and microbial infection.