QuantRX Penny FDA Play Continues To Rise Print E-mail
By Dallas Croce   
Monday, 08 November 2010 00:00

Many of our readers should remember the FDA craze that hit the trading community around this time last year. It kept providing speculative penny players substantial gains in relatively short periods of time.
Remember NEPH (.03 to 2.25+ in under 4 months) and BIEL (.002 to .10+ in just over 4 months).

Both of these stocks ran on their 510k FDA submissions and last Friday, we told our paid subscribers about a similar stock which has returned 77% since our initial trade alert.

The company, QuantRX Biomedical Corp. (OTCBB: QTXB), is a pure penny play with a recent 510k submission. The stock should continue to get attention, given its interesting technology and upside potential.

On June 9th, 2010, “QuantRx Biomedical Submitted A 510(k) Application To FDA For Thyroid Point-of-Care Testing System Following Successful Completion Of Studies”.  As you know, the FDA requires approximately six months to award 510(k) approvals.

December 9th 2010 will be exactly six months from the day QTXB submitted the application.

While PDUFA dates are for drugs, and 510k applications are for medical devices and  "in order to be eligible for 510(k) clearance, the new device must exhibit roughly the same safety and effectiveness characteristics as the “predicate” device to which the new one is being compared.”

Now is the time most of these plays start to pick up momentum. The “hype” in the penny stock community begins to spread and stock prices start to rise in anticipation of these decisions. If approval of the device greatly increases the company’s chances of turning profits, then the PPS drives upward into an entirely new trading range. Even the mere possibility of approval results in a buying frenzies for these types of stocks. That’s why we are alerting QTXB as both a potential approval and “rumor rise” play.

The company's QN Diagnostics (QND) Q-Reader is a stand-alone instrument with a liquid crystal display (LCD) touch screen located on the top of the unit, and an integrated software analysis capability. Using QND's proprietary analysis software, the unit uses stored calibration data provided with each QND Assay Kit and an analyze concentration based upon the analyze-specific calibration curve to display a quantifiable reading to the healthcare practitioner on the LCD screen.

Proprietary QND Assays are housed within a plastic cassette, which contains a QND-lateral flow Assay Strip. The test system is intended for use at the point of care and to eliminate the need for samples to be taken from the patient and shipped with related documentation to an external laboratory, saving the time needed to return the test results to the health care practitioner.

Information about the company:

“QuantRx Biomedical Corporation (OTCBB: QTXB) is an emerging leader in the development of products for advanced diagnosis of serious disease and health conditions. With synergistic expertise in the discovery of diagnostic platforms and the commercialization of products for use by medical professionals, institutions or consumers. QuantRx is focused on providing more accurate, reliable and faster diagnoses that result in improved patient care.” The QuantRx strategy is one of sustained growth and targets significant market opportunities estimated to be in excess of $4 billion worldwide.

QTXB is not a stranger to big companies or knowing how things work. Read this excerpt from their website:

“QuantRx's partnership with Procter & Gamble is a multiyear, multimillion-dollar licensing agreement that allows QuantRx to incorporate patented P&G technology into QuantRx PAD technology-based products for a number of healthcare markets. The Company has also entered into an important development agreement with ALT BioScience.”

“The Company holds a significant position in FluoroPharma, Inc., a Boston-based molecular imaging company, and in Genomics USA, Inc., a Chicago-based developer of microarray technology for DNA testing. “ 

Links for both of those companies below:
The submissions team behind this application appears to have experience getting products across the finish line as a quick search of their history reveals four previous 510k approvals.

In October of 2007, for example, “QuantRx Biomedical Corporation Announces FDA 510(k) Clearance for Its Follicle Stimulating Hormone (FSH) Immunoassay Test”.  Link here: http://bit.ly/bifWR8

Again, in January of 2009, “QuantRx(R) Announces FDA 510(k) Clearance For Its RapidSense(R) Phencyclidine (PCP) Test.” Link here: http://bit.ly/amnSgk

Disclosure: No Positions

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