Health Discovery Corporation (OTC:HDVY) Developments Update Print E-mail
By Peter DePalma   
Monday, 01 February 2010 03:00
Record interest in Health Discovery Corporation (OTC:HDVY) continues. Is the company on the verge of a major development? This weekend, we were able to track down a company official who, while very gracious, said that company would likely not have much to say for "at least a few days" due to the nature of some "very sensitive non-disclosure agreements that are in place with both existing and potential partners."

Under condition of anonymity, however,  the representative was able to confirm to BioMedReports that there was "significant response" to last week's presentation in Dallas. "It was much more significant than the response we had during our presentation at the end of October in Philadelphia," said the source.

As we reported to our subscribers last week, HDVY made a presentation in front of a nationwide network of independent broker/dealers, investment bankers and other finance leaders at the FSX Conference which took place at the Ritz Carlton Hotel in Dallas. Friday, the company experienced a record day in trading volume and shares rose over 25%-  trading as high as $.31 before closing out the session at $.276.

Some slides from HDVY's recent presentation to bankers and brokers in Dallas (click icon in the bottom right center of the player to watch full-screen):

Activity and volume for the stock had increased during the past two sessions after speculation that one of HDVY's diagnostic tests for prostate cancer may finally be ready for commercialization. If those rumors are true, then shares of the company could rise dramatically upon official confirmation- especially since such news would signal a paradigm shift in the way men are screened for prostate cancer not only in the U.S., but around the world.

The most current and common screening test for prostate cancer used today misses up to 82% of cancers in men younger than 60 and 65% in those older than 60, according to a past study in the New England Journal of Medicine.

That blood test, known as prostate-specific antigen, or PSA, is used in an attempt by most doctors  detect early prostate cancer, but studies have found that results tend to trigger a biopsy in far too many cases.

One of the most famous cases involves one-time Democratic presidential candidate John Kerry, who had a PSA reading of 3.4- which doctors consider within the "normal" range. His wife noted that the reading was slightly elevated from a previous test and she urged him to go in for more testing. Sure enough, cancer was found and he had to have his prostate removed.

So why all the excitement and interest in HDVY's various tests and related technologies?

According to some of the information which was presented in Dallas and obtained by BioMedReports the company claims that their various Molecular Diagnostics Tests:
  • Detect disease at an earlier stage
  • Enable the selection of optimal therapy
  • Reduce trial-and-error prescribing
  • Reduce adverse drug reactions
  • Increase patient compliance with therapy
  • Improve the selection of targets for drug discovery
  • Reduce the time, cost, and failure rate of clinical trials
  • Reduce the overall cost of healthcare

Information presented at the conference indicates that Health Discovery Corporation's new urine based molecular diagnostic test for prostate cancer has co-exclusive royalty bearing licenses with Abbot, Quest Diagnostics and Clarient. HDVY is set to receive payments, royalties and additional undisclosed financial considerations from the commercialization of the tests.

The PSA test has been heavily criticized in Academic Institutions and the media for it’s poor performance in the recent peer-reviewed publication in the New England Journal of Medicine.

In March of 2009, a US study concluded that after following men for a decade, those screened annually with the PSA or a rectal exam were no more likely to avoid death from prostate cancer than those tested less frequently or not at all.

"I'm 50 times more likely to receive unnecessary treatment than I am to be the one who avoided the prostate cancer death," said Dr. H. Gilbert Welch, a Department of Veterans Affairs researcher in White River Junction, Vt., who studies the consequences of cancer screening. "From my perspective, that's not a very good gamble."

"These studies make it difficult to have a one-size-fits-all recommendation," said Dr. Michael Barry, of Massachusetts General Hospital to the Boston Globe. Barry has extensively studied prostate cancer screening and points out that: "If a man has his eyes open and knows the risks and knows what the trade- offs are, he may either want or not want the PSA."

Since its adoption in the late 1980s, PSA testing has been bolstered by studies showing that prostate deaths overall were declining. Testing was sometimes given credit, but at the same time that screening was becoming more widespread, treatments for the disease were improving.

But those treatments can leave a man impotent or incontinent without any guarantee that a tiny tumor lodged in the prostate would ever have threatened his life.

The lead author of that US study, Dr. Gerald Andriole, said he hoped the studies will "temper those sort of knee-jerk responses" that have led to men with positive PSA tests being rushed into the operating room.

"PSA and the fear of prostate cancer are absolutely ingrained in Western societies," said Andriole, chief of urologic surgery at Washington University in St. Louis. "If we could have a very candid conversation with patients who have very tiny tumors, maybe we could spare them the side effects of aggressive treatment of prostate cancer."

The current PSA test shows sensitivity of 70%-80% and a Specificity of 60%-70%.

HDVY's prostate cancer tests showed 90% Sensitivity for correctly identifying the presence of Grade 3 or higher prostate cancer cells and 97% Specificity for correctly identifying non-cancer cells (normal and BPH).

The current market statistics show that 50 million PSA’s are performed worldwide annually. The price of these PSA tests in the US is approximately $100 per test - which represents a $5 billion market.

Speculators appear to be betting that HDVY's new prostate cancer test is not only about to be commercialized, but that it has a very good chance of replacing the current PSA test for multiple reasons, including the fact that Health Discovery Corporation's urine based prostate cancer test is non-invasive (only requiring a urine specimen), while the PSA test requires an invasive blood collection procedure.

Disclosure: No Positions



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