Revisiting our FDA Play - $QTXB

admin | December 6, 2010

Here is a copy of our original email we sent about QTXB. After the initial run, QTXB dropped to .06 and is now trending back back in anticipation of its 510(k) FDA submission. Read the following information to get all the details on QTXB, including their 4 / 4 FDA submission success rate.

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”. Biomedical websites across the internet put a six month estimate on 510(k) decisions. Websites across the internet put a 6month estimate on 510(k) medical device submissions, so December 9th, 2010 is the estimated date.


Many investors should remember the FDA craze that rung around the trading community around this time last year, providing immense gains in relatively short periods of time. Some examples include NEPH (.07 to 2.25+ in under 4 months) and BIEL (.006 to .10+ in just over 4 months). Both of these stocks ran on hype of their 510(k) FDA submission. A 510(k) application is for medical device clearance, allowing the product to be placed on store shelves. In simpler terms, PDUFA dates are for drugs, and 510(k) applications are for medical devices. “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.”

We have found a company with a recent 510(k) submission and we believe that this company deserves some attention, as it has very promising technology, and it’s price per share is extremely attractive, leaving lots of upside potential.

The company we are looking at is QuantRX Biomedical Corp. (OTCBB: QTXB)

We encourage you to visit their website, containing more info that we can provide in an email:

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”. Biomedical websites across the internet put a six month estimate on 510(k) decisions. Therefore, December 9th, 2010 will be exactly six months away from when they submitted the application.

Seeing as that is only about a month away, it is around this time that the “hype” in the penny stock world starts circling such potential plays. The reason is because an FDA approval for a company’s device greatly increases the company’s chances of being profitable, therefore driving the PPS upward into an entirely new trading range. However, even the mere possibility of approval results in a buying frenzy amongst investors who want to get in BEFORE the new trading range is realized. That’s why we are alerting QTXB now, as we feel it’s best to take advantage of both the potential approval and the “rumor rise” before hand.

Here’s some info on their technology:

The 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.

Let us now highlight some more information about this 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.”

A quick search of their history reveals FOUR previous 510(k) approvals ! In fact, as far as we can tell, every 510(k) application QTXB has ever submitted has been APPROVED ! They are at a 100% approval rate !

Will history will repeat itself ?

In February of 2009:

In January of 2009: “QuantRx(R) Announces FDA 510(k) Clearance For Its RapidSense(R) Phencyclidine (PCP) Test”:

In December of 2008:

In October of 2007: “QuantRx Biomedical Corporation Announces FDA 510(k) Clearance for Its Follicle Stimulating Hormone (FSH) Immunoassay Test”:

We are aware this stock was up 80% yesterday, but take a look at the time and sales and you will see half of the volume was selling. We do believe some dedicated subscribers were able to guess the symbol due to the amount of hints we gave. Keep in mind that QTXB just hit a new 52 week low, so a bounce should not be of surprise. As you can see on a chart, it is not still near its normal trading range. We would not be alerting QTXB if we didn’t believe that gains were still possible from these levels, both long term and short term. The trading yesterday just reassured us of the “thinness” of this stock. The average price (20 day) is still around .06, and that is the reason we still believe gains can be made. According to their last 10Q filing, QTXB has 150,000,000 authorized with 44,427,630 shares outstanding.

Add QTXB to your watchlist now !

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