Healthcare Industry News: imaging agent
News Release - October 25, 2007
QuantRx Biomedical Corporation Announces FDA 510(k) Clearance for Its Follicle Stimulating Hormone (FSH) Immunoassay Test
New One-Step Lateral Flow Device to Quickly and Efficiently Measure Hormone Levels for Women Attempting to ConceiveDOYLESTOWN, PA--(Healthcare Sales & Marketing Network)--Oct 25, 2007 -- QuantRx Biomedical Corporation (OTC BB:QTXB.OB ), a broad-based diagnostic company focused on the development and commercialization of innovative diagnostic products, today announced that the U.S. Food and Drug Administration (FDA) has granted the Company 510(k) clearance on its Follicle Stimulating Hormone (FSH) lateral flow immunoassay test for the detection of FSH at 10ng/ml. The QuantRx Biomedical Female Fertility test is a one-step lateral flow device that determines ovarian reserve indirectly by measuring FSH in first morning urine. The product is intended to aid women who are attempting to conceive and are experiencing difficulty. The QuantRx Biomedical Female Fertility test can produce results within 15 minutes, approximately half the time of the sole competing product currently in the marketplace.
"The new clearance allows the Company to provide its customers with a new and innovative product for women's health in the over-the-counter (OTC) market," stated Mrs. Cindy Horton, Vice President of Diagnostics at QuantRx. "QuantRx Biomedical is well on its way to capitalizing on the burgeoning female and male fertility markets with the clearance of its first female fertility test and we believe these markets offer tremendous near-term opportunities for QuantRx. QuantRx has over half a dozen additional lateral flow tests in the 510(k) pipeline including a menopause test. Additionally, QuantRx is developing a male fertility test for introduction in 2008."
The female infertility market has rapidly expanded in recent years as couples postpone having children due to lifestyle trends. According to the American Society for Reproductive Medicine, "Problems with ovulation are common causes of infertility, accounting for approximately 25% of all infertility cases." More than six million people of childbearing age in the U.S. experience infertility every year, and one million seek treatment. The QuantRx Biomedical Female Fertility test will now enable women to expeditiously determine if they should pursue further fertility evaluations.
About QuantRx Biomedical (www.quantrx.com)
QuantRx Biomedical Corporation (OTC BB:QTXB.OB ) is a broad-based diagnostics company focused on the development and commercialization of innovative diagnostic products based on its patented technology platforms for the worldwide healthcare industry. With synergistic expertise in the discovery of diagnostic platforms and the commercialization of products for use by healthcare professionals and consumers, QuantRx is focused on providing more accurate, reliable, and faster diagnoses that result in improved patient care.
The QuantRx strategy targets significant market opportunities estimated to be in excess of $5 billion worldwide. The Company's technology portfolio, with more than three dozen patents, patents pending and licensed patents, includes: (1) RapidSense® point-of-care testing products based on QuantRx core intellectual property related to lateral flow techniques for the consumer and healthcare professional markets; (2) genome-based diagnostic chips for the laboratory and healthcare professional markets; (3) molecular imaging agents for positron emission tomography (PET) and fluorescence imaging, with initial application in cardiovascular disease, addressing significant unmet medical needs by providing clinicians with important tools for early discovery and assessment; and (4) PAD technology for diagnosis and treatment of women's health concerns and other medical needs.
QuantRx has corporate offices in Doylestown, Pennsylvania, and its research and development center in Portland, Oregon. The Company holds a majority position in FluoroPharma, Inc., a Boston-based molecular imaging company, and a significant position in Genomics USA, Inc., a Chicago-based developer of microarray technology for DNA testing.
This release may contain forward-looking statements within the meaning of the federal securities laws. Such forward-looking statements reflect, among other things, management's current expectations, management's current plans and strategies, and anticipated financial results, all of which are subject to known and unknown risks, uncertainties and factors that may cause our actual results to differ materially from those expressed or implied by these forward-looking statements. Many of these risks are beyond our ability to control or predict including; general economic conditions, the Company's need for additional funds, the early state of the products the Company is developing, uncertainties relating to clinical trials and regulatory reviews, competition and dependence on collaborative partners, the Company's ability to avoid infringement of the patent rights of others, and the Company's ability to obtain adequate patent protection and to enforce these rights. Because of these risks, uncertainties and assumptions, you should not place undue reliance on these forward-looking statements. Furthermore, forward-looking statements speak only as of the date they are made. QuantRx does not undertake any obligation to update or review any such forward-looking information, whether as a result of new information, future events or otherwise.
Source: QuantRx Biomedical
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