QUANTRX BIOMEDICAL CORPORATION

QUANTRX BIOMEDICAL CORPORATION

Previous company name
A-FEM MEDICAL CORPORATION
Name change date
12/2/2005
Company Overview
QuantRx Biomedical Corporation, formerly known as A-Fem Medical Corporation, is a biomedical company engaged in the research, development, acquisition and commercialization of medical diagnostic products primarily in the United States. The company was founded in December 1986. The registered headquarters of the company is located Doylestown, Pennsylvania. The company is publicly traded on the NASDAQ OTC BB under the ticker symbol QTXB.
QuantRx Biomedical develops diagnostic platforms and products for professional, industrial and consumer use. The platforms include: Miniform, a disposable technology with applications in the incontinence and hemorrhoidal over-the-counter markets; RapidSense, a point-of-care diagnostic technology; PadKit, a technology for various consumer health issues, such as temporary relief of hemorrhoid discomfort, feminine incontinence, drug delivery, and medical sample collection for diagnostic testing; and a collection device for oral fluids. The company’s registered trademarks are PadKit, RapidSense, inSync and Unique.
QuantRx Biomedical serves as the leader in the development of products for advanced diagnosis of serious disease and health conditions in the United States. The company aims to commercialize products through partners or distributors; to contract manufacture with third parties while maintaining control over the manufacturing process; and to assume responsibility for the development of the products and their conformity to U.S. regulatory requirements.
QuantRx Biomedical has strategic alliance with Synova Healthcare Group, Inc., a US-based enterprise engaged in the development, distribution, marketing and sale of non-invasive medical diagnostic tests; Procter & Gamble, a US-based company engaged in the provision of branded consumer goods products; and ALT BioScience, LLC, a US-based group involved in the discovery, development and commercialization of diagnostic and biomedical technologies focused on oral-systemic health, neurodegenerative diseases and nucleotide photoaffinity labeling for basic protein research.
Business Summary
QuantRx Biomedical Corporation (QuantRx) is a diagnostics company focused on the development and commercialization of point-of-care (POC) diagnostic products based on its technology platforms for the worldwide healthcare industry. The Company’s platforms include RapidSense POC testing products based on QuantRx core intellectual property related to lateral flow methods, devices, and processes for the consumer and healthcare professional markets; PAD products based on QuantRx technology for aiding the treatment of hemorrhoids, minor vaginal infection, urinary incontinence, and other medical needs, including diagnostic sampling products, which enable self collection and worldwide transport; Single Nucleotide Polymorphism (SNP) chips; genome-based diagnostic chips for the laboratory and healthcare professional markets, and molecular imaging agents for Positron Emission Tomography (PET), with initial application in cardiovascular disease.
Description and history
QuantRx Biomedical Corporation (QuantRx), incorporated on December 5, 1986, is a diagnostics company focused on the development and commercialization of point-of-care (POC) diagnostic products based on its technology platforms for the worldwide healthcare industry. The Company’s platforms include RapidSense POC testing products based on QuantRx core intellectual property related to lateral flow methods, devices, and processes for the consumer and healthcare professional markets; PAD products based on QuantRx technology for aiding the treatment of hemorrhoids, minor vaginal infection, urinary incontinence, and other medical needs, including diagnostic sampling products, which enable self collection and worldwide transport; Single Nucleotide Polymorphism (SNP) chips; genome-based diagnostic chips for the laboratory and healthcare professional markets, and molecular imaging agents for Positron Emission Tomography (PET), with initial application in cardiovascular disease, addressing significant unmet medical needs by providing clinicians with tools for discovery and assessment.

Lateral Flow Diagnostics

QuantRx has developed a RapidSense technology, a one-step lateral flow test with features, such as positive indication for a positive test, which when combined with the Q-Reader platform allows the Company to target quantified POC diagnostics previously limited to the diagnostic laboratory. These applications include but are not limited to thyroid disease, therapeutic drug monitoring, cancer diagnostics, diagnosis of cardiac disease, and other critical tests. This rapid POC diagnostic technology is ideal for testing any body fluid, including whole blood, serum, oral fluids and urine. QuantRx has also patented oral fluid collection devices specifically designed for its RapidSense technology. These distinctive collection devices coupled with RapidSense and the reader platform enable to target the large and growing markets for diagnostics using oral sample collections, which have heretofore been limited to blood or urine testing.

RapidSense products target the POC healthcare professional human and veterinary diagnostic markets. QuantRx is also exploring parallel opportunities in the veterinary markets. Q-Reader enables the translation of lateral flow results beyond a qualitative positive or negative and produces a test-specific quantified result so that changes in body chemistry can be measured in the primary care practitioner’s office. During the year ended December 31, 2009, the Company commenced the commercialization of the licensed Follicle Stimulating Hormone (FSH) lateral flow immunoassay test for FSH. QuantRx jointly developed this female fertility test with Church & Dwight.

PADs for Diagnosis and Treatment

The miniform PAD is a QuantRx technology that provides the basis for a line of products that address an array of consumer health issues, including temporary relief of hemorrhoid and minor vaginal infection itch and discomfort, feminine urinary incontinence, drug delivery, and medical sample collection and transport for diagnostic testing. The QuantRx PAD products for the consumer markets are FDA Class I OTC devices, and are non-invasive, fully biodegradable and absorbent pads. In addition, the technology allows for the PAD to be used as a sample collection device for diagnostic purposes, or to provide local or systemic therapy.

The PADKit integrates the miniform technology with QuantRx’s diagnostic capabilities. The PADKit contains a miniform used as a collection device to collect a sample for diagnostic evaluation. Vaginally, the miniform collects blood along with numerous cells, vaginal mucous and discharge flushed out by the menstrual flow or during normal daily exfoliation. The PADKit is designed to provide the sample collection system population scale testing for indications, such as human papillomavirus (HPV), HIV and general health screening, where healthcare professionals are not readily accessible.

The Company’s Unique miniform is a flushable technology for the OTC hemorrhoid and feminine urinary incontinence markets. The disposable miniform pads contain no adhesives and require no insertion, and it is small enough to fit in the palm of a hand. The Unique miniform is available as a treated pad for the temporary relief of the itch and discomfort associated with hemorrhoids and minor vaginal infection, and as an untreated pad, for the daily protection of light urinary or anal leakage. While QuantRx initiated a limited Web-based, domestic roll-out of the Unique miniform in 2007, it is in search of a strategic partnership(s) to expand the retail availability of the product across the United States and internationally.

Molecular Diagnostic Imaging

The Company, through FluoroPharma, is developing diagnostic imaging products, with initial focus on the development of PET imaging agents for detection and assessment of acute and chronic forms of coronary artery disease (CAD). The technology has been applied to the development of three cardiovascular imaging agents, CardioPET, BFPET, and VasoPET. The agents target either the myocardial cells within the heart or the vulnerable plaque within the coronary arteries, and combined with PET scanning, provide a non-invasive assessment of heart metabolism and physiology. Applications also exist in the cardiovascular, oncology and neurology arenas.

CardioPET, FluoroPharma’s lead product, is a metabolic agent in development for uses, such as detection of ischemic and infarcted tissue in patients with suspected or proven forms of acute and chronic CAD, particularly in those patients that cannot undergo stress testing, and cardiac viability assessment (CVA), for the prediction of functional improvement prior to, or following, revascularization in patients with acute CAD, including myocardial infarction. VasoPET is a imaging agent for the detection of inflamed and/or coronary artery plaque formation in patients with CAD.

BFPET is a blood flow imaging device being developed for use as a myocardial perfusion agent in conjunction with stress-testing for the detection of ischemic and infarcted myocardial tissue in patients with suspected or proven chronic CAD. BFPET has been designed to enter the myocardial cells of the heart muscle in direct proportion to blood flow and membrane potential the two physiological indicators of adequate blood supply to the heart. BFPET effectively differentiates between those cells of the myocardium that are ischemic (reversibly damaged), infarcted (irreversibly damaged), and those that are healthy. Because ischemic and infarcted cells take up significantly less BFPET than normal healthy myocardial cells, the signal emitted by the tracer attached to BFPET is inversely proportional to the extent of myocardial injury, the result, of which can be visualized with PET imaging technologies.

The Company competes with Inverness Medical Innovations, Inc., Biosite, Inc., Quidel Corporation, and Meridian Bioscience, Inc.

Formerly known as A-Fem Medical Corporation

Business Line
Biomedical company engaged in the research, development, acquisition and commercialization of medical diagnostic products primarily in the United States
Subsidiary
FLUOROPHARMA, INC.
Advisor
BEHLERMICK PS
IPO date
11/10/2005
US SIC Code
2835
Company Address
Suite 300
100, S. Main Street
City province or state postal code
18901, DOYLESTOWN, PA
Phone: +1 267 880 1595
Fax: +1 267 880 1596
Country address: UNITED STATES OF AMERICA
Website url: www.quantrx.com