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bob smith

03/21/10 12:51 AM

#5502 RE: AccipiterQ #5501

accipter,

diagnostic medicine always runs in secrecy, and every budding physician thinks they have found something promising.
this group is private clinic with deep pockets that focuses on brachytherapy---they may disclose their own technique.....?

who knows, an exmple of the intense turnover would be 2 articles from 2007, and 2009 (below) that discuss several methods that are defunct, and their studies have not proceded beyond the article.

by saying this, HDVY needs to pressure on quest to speed up the process, because their are people looking under every rock and searching for the holy grail.

Further, i would not be worried by this conference, it a dime a dozen......its a small private group, not a nationally recognized conference.

after reviewing the group, i'm not too impressed, or worried.

gl


http://www.webmd.com/prostate-cancer/news/20070426/new-blood-test-for-prostate-cancer


April 26, 2007 -- An experimental blood test for prostate cancer seems to work better than the current PSA test -- and can tell whether the cancer is spreading.

The new test looks for a protein called EPCA-2 -- or early prostate cancer antigen 2. Unlike the PSA (prostate-specific antigen) protein on which the current PSA test is based, this protein isn't found in normal prostate cells. Instead, EPCA-2 occurs in relatively large amounts only in prostate cancer cells.

The test is being developed by Robert H. Getzenberg, PhD, director of urology research at Johns Hopkins University's Brady Urological Institute. Getzenberg began the work while still at the University of Pittsburgh; the test has been licensed to the Seattle biotech firm Onconome Inc.

"We wanted to find something that really identified people with prostate cancer and not people with enlarged or infected prostates," Getzenberg tells WebMD. "This is as close to cancer specific as we could find. We found it is very unique. It is 97% specific, meaning that if you test positive there's only a 3% chance you don't have prostate cancer."

Getzenberg has a financial interest in the test. But experts who do not stand to gain from the test agree that it has enormous potential.

Otis Brawley, MD, chief of the solid tumor service at Emory University's Winship Cancer Institute, calls the test "important" and predicts it will be widely used.

Charles A. Coltman Jr., MD, associate chairman for cancer control and prevention at San Antonio's Southwest Oncology Group, calls the findings "striking" and "remarkable," although he warns that the test has been tried out on only a small number of patients.

Ganesh Palapattu, MD, assistant professor of urology at the University of Rochester, agrees that more studies must be done. But he tells WebMD that the test is a big step toward the "Holy Grail of prostate cancer detection: not so much identifying men with prostate cancer, but identifying men with prostate cancer who have aggressive disease."

"This not only helps tell whether you have prostate cancer, but what kind of prostate cancer you have," Getzenberg says.

Getzenberg and colleagues report early studies of the EPCA-2 test in the April issue of the journal Urology.

EPCA-2 Test Beats PSA
Nobody is entirely happy with the current PSA test for prostate cancer. A man without prostate cancer can have high PSA levels. A man with advanced prostate cancer may have very low PSA levels.

Getzenberg's team tried out the EPCA-2 test on blood samples from several different groups of people. Some were known to have early prostate cancer or late prostate cancer, and some had other kinds of cancer. Some had enlarged prostates, but not cancer. Some were women, who have no prostate gland. And some were healthy men with normal PSA levels.

page 2
New Blood Test for Prostate Cancer
Experimental Test Detects Prostate Cancer, Tells Whether It Is Spreading(continued)
EPCA-2 Test Beats PSA continued...
Both in terms of detecting cancer when it was actually there (sensitivity), and in terms of not detecting cancer when it wasn't actually there (specificity), the EPCA-2 test beat the PSA test.

More importantly, it beat the PSA test in predicting whether prostate cancer already had spread outside the prostate gland. When that has happened, standard treatments for prostate cancer -- radical prostatectomy (surgery to remove the prostate) and brachytherapy (tiny radioactive seeds implanted in the prostate) -- fail to cure.

"I predict that within the next year, this test is going to be widely used to find the guy who has prostate cancer and who, if he got radical prostatectomy, would relapse very quickly," Brawley tells WebMD. "It is going to say to this guy, 'Skip the unnecessary surgery and get pelvic radiation and hormone treatment now.'"

Getzenberg says it will be at least two years before the test is "out on the street" with FDA approval. All of the experts who spoke to WebMD agree that large-scale screening tests will be needed before it's known exactly how well the test works.

"What we really need to know is how this test behaves in all comers -- when we don't already know whether the men being tested have prostate cancer," Palapattu says. "It would also be important to identify men with high risk of prostate cancer vs. low risk of prostate cancer, and to test men after prostate surgery to see whether it can predict cancer recurrence."

When -- and if -- the EPCA-2 test is approved, men will still need better prostate cancer tests.

"At least a third, maybe two-thirds of guys with localized disease have cancer that will never leave the prostate and never bother them," Brawley says. "This new test is not going to help those guys who get treated for prostate cancer but shouldn't. I hope there will be help for these men soon."


article 2

http://www.sciencedaily.com/releases/2009/05/090528120729.htm

New Blood Test Greatly Reduces False-Positives In Prostate Cancer Screening
ScienceDaily (May 29, 2009) — A new blood test used in combination with a conventional prostate-specific antigen (PSA) screening sharply increases the accuracy of prostate cancer diagnosis, and could eliminate tens of thousands of unneeded, painful, and costly prostate biopsies annually, according to a study led by researchers at Dana-Farber Cancer Institute.


At the annual meeting of the American Society of Clinical Oncology in Orlando, Fla., William K. Oh, M.D., and Robert W. Ross, M.D., will report that the six-gene molecular diagnostic test, when combined with a PSA test, accurately detected prostate cancer more than 90 percent of the time. Earlier studies suggest that the conventional PSA test is 60-70 percent accurate in detecting cancer. The findings will be discussed at a poster session on May 31.

Men who are found to have elevated levels of PSA in routine screening tests are often referred for a biopsy of the gland to check for tumors. Nearly two-thirds of biopsies performed -- a painful procedure with some risk of complications -- do not find any cancerous cells. This high rate of "false positive" PSA test results underscores the need for a more accurate method for detecting prostate cancer, said Oh, who is the clinical director of the Lank Center for Genitourinary Oncology at Dana-Farber.

The two-year study involved 484 participants. The group comprised 204 men with known prostate cancer, 110 men with benign prostatic hypertrophy (BPH), and 170 healthy men in a control group. (BPH can elevate PSA levels in the blood, which often leads to a biopsy to rule out prostate cancer.) These groups were split into age-matched training and validation sets.

The researchers sought to measure the accuracy of a six-gene whole blood RNA transcript-based diagnostic test developed by Source MDx in Boulder, Colo., both in terms of its sensitivity (the ability to detect prostate cancer) and specificity (the ability to identify people who don't have prostate cancer).

Source MDx researchers developed the test after initially working with a set of 174 candidate genes whose activity was compared in the different study groups. They narrowed the pool down to just six genes that, as a group, were highly sensitive in predicting which patients had prostate cancer and which were normal.

The study found that "the six-gene model was more accurate than PSA alone at predicting cancer if you had it and no cancer if you didn't," said Oh. The test's accuracy improved even more when PSA measurements were added. Combined, the two tests achieved a diagnostic accuracy of more than 90 percent in specificity and sensitivity and eliminated most of the false-positives yielded by the PSA test.

Based on these findings, the researchers are planning to conduct a larger, multicenter clinical trial involving approximately 1,000 men to determine if the findings remain valid.

"These findings are very encouraging and suggest that this new test could spare tens of thousands of men from undergoing an unnecessary biopsy," Oh said. "However, until we can verify our findings, it is important to recognize that the PSA test, despite its limitations, is still the best test available for diagnosing prostate cancer at this time."

The study was funded in part by Source MDx and a Prostate Cancer SPORE grant at Dana-Farber/Harvard Cancer Center.


bob smith

03/21/10 1:13 AM

#5503 RE: AccipiterQ #5501

check out this website, and refer to related articles....
http://www.sciencedaily.com/releases/2006/09/060915203246.htm

there are probably dozen prostatic diagnostics tests in the works.

dating back from 2005 to 2009.

check out this article...featuring a paid consultant GPRO.

New Urine Test Detects Prostate Cancer Better Than Other Methods, Study Suggests
ScienceDaily (Feb. 5, 2008) — An experimental biomarker test developed by researchers at the University of Michigan more accurately detects prostate cancer than any other screening method currently in use, according to a study published in the February 1 issue of Cancer Research, a journal of the American Association for Cancer Research.

The researchers say a simple urine test that screens for the presence of four different RNA molecules accurately identified 80 percent of patients in a study who were later found to have prostate cancer, and was 61 percent effective in ruling out disease in other study participants.

This is far more accurate than the PSA blood test currently in use worldwide, which can accurately detect prostate cancer in men with the disease but which also identifies many men with enlarged prostate glands who do not develop cancer, researchers say. Even the newer PCA3 test, which screens for a molecule specific to prostate cancer and which is now in use both in the U.S. and Europe is less precise, they say.
"Relative to what is out there, this is the best test so far," said the study's lead author, Arul Chinnaiyan, M.D., Ph.D., director of the Michigan Center for Translational Pathology at the University of Michigan.

He also says that this "first generation multiplex" biomarker test will likely be improved upon as researchers continue to uncover the molecular underpinnings of prostate cancer.

"We want to develop a test to allow physicians to predict whether their patients have prostate cancer that is so accurate a biopsy won't be needed to rule cancer out," Chinnaiyan said. "No test can do that now."

Chinnaiyan and the Michigan researchers developed the test based on their recent finding that gene fusions - pieces of chromosomes that trade places with each other, causing two genes to stick together - are common in prostate cancer, and that by overriding molecular switches that turn off excess growth, they may be the causative factor in some forms of the disease. In 2005 they identified a prostate-specific gene called TMPRSS2 which fuses with either ERG or ETV1, two genes known to be involved in several types of cancer. In 2007, they identified another five genes that fuse on to ERG or ETV1 to cause prostate cancer.

In the current study, researchers built upon the PCA3 test by screening for six additional biomarkers, including TMPRSS2:ERG as well as some molecules generally over-expressed in prostate cancer, and some which are over-expressed in specific cancer subtypes.

Researchers collected urine samples from 234 men with rising PSA levels before they underwent prostate biopsy at a University of Michigan urology clinic. Among this group, biopsy results confirmed a diagnosis of prostate cancer in 138 patients; 96 patients were cancer-free.

Correlating the urine biomarker test results with the biopsy data, researchers found that, in combination, four of the seven biomarkers were significant predictors of prostate cancer: GOLPH2, which is generally over-expressed in prostate cancer; SPINK1, over-expressed in a subset of these cancers; the PCA3 transcript expression; and TMPRSS2:ERG fusion status. Of the seven markers, only PCA3 had been previously reported as a diagnostic biomarker.

When tested as individual biomarkers, GOLPH2, PCA3, and SPINK1 each outperformed PSA, which had identified all of the men in the study as potentially positive for prostate cancer. "PSA was not predictive at all," Chinnaiyan said. "You might as well have flipped a coin."

The combination of the four biomarkers achieved a specificity and positive predictive value of greater than 75 percent, which they found to be five percent better than use of a PCA3 test alone, he says. Specificity is the probability that a test indicates a negative result if a person does not have a disease, and the positive predictive value is the proportion of patients with positive test results who are correctly diagnosed.

Chinnaiyan believes that any tests that are developed and widely tested would first be used to supplement a PSA blood screen.

The study was funded by the Early Detection Research Network, Department of Defense, the National Institutes of Health, the Prostate Cancer Foundation, and Gen-Probe Incorporated of San Diego. The gene fusion technology has been patented by the University of Michigan and licensed to Gen-Probe Inc, which is also developing the PCA3 screening test. Chinnaiyan is a paid consultant to Gen-Probe.

gl

rocketeer357

03/21/10 4:36 AM

#5504 RE: AccipiterQ #5501

I'm not worried. I think the news of a urine test for prostate cancer in this conference will point to a time in the future (hopefully near) when the urine test is a standard care tool for urologists and MDs. And I think HDVY will be the provider (first at any rate) of this test.

I don't think Quest signs up for another go with HDVY (breast cancer test) if they don't feel very confident with the prostate test.

Barnhill has never been a one trick pony. I don't accept the idea that development of other tests and applications is a concession of defeat with the prostate urine test. On the contrary, it's the sign of a healthy company with a lot in the pipeline.