QuantRx(R) Announces FDA 510(k) Clearance For Its RapidSense(R) Methamphetamine Test

Main Category: Alcohol / Addiction / Illegal Drugs
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 08 Jan 2009 - 5:00 PDT

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QuantRx Biomedical Corporation (OTCBB: QTXB), a broad-based diagnostic company focused on the development and commercialization of innovative diagnostic products, announced that the U.S. Food and Drug Administration (FDA) has granted the Company 510(k) clearance on its RapidSense drugs-of-abuse (DOA) Methamphetamine test. The RapidSense Methamphetamine test is the first of QuantRx' DOA tests based solely on its proprietary technology approved by the FDA. The RapidSense Methamphetamine test is a one-step positive read lateral flow device intended for use in the professional markets.

"The new clearance allows the Company to provide its customers with a new and innovative product for DOA testing, which we believe will complement our current sales efforts and allow us to expand beyond our traditional OEM product base," stated Dr. William Fleming, President of Diagnostics at QuantRx. "QuantRx Biomedical is well on its way to capitalizing on the burgeoning point-of-care testing markets with the clearance of its first DOA panel and we believe these markets offer tremendous near-term opportunities for QuantRx. QuantRx hopes to build upon its point-of-care franchise as it currently has over half a dozen additional lateral flow tests in the 510(k) pipeline."

"We are pleased to have reached this important milestone," stated Mr. Walter Witoshkin, QuantRx' Chairman and CEO. "This is a clear signal that our RapidSense technology will bring real innovation to the broad U.S. marketplace."

"We anticipate this will be the first of multiple approvals from the FDA for our technology," Mr. Witoshkin added.

About QuantRx Biomedical

QuantRx Biomedical Corporation (OTCBB:QTXB) 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.

QuantRx Biomedical

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