Sorry - just turned on the computer and need to vent ...
This is the sleazy, juvenile part of investing I detest. Yes, I’m an investor in this stock because unlike the author, who was covering software for upsidedown.com up until 2001, I‘ve been deeply entrenched in this industry since 1988. Yes, I’ll say it here, I know much more about this industry and the process that Adam Feuerstein. This action by the Street.com has as much sleaze factor as Cramer hyping Double Click and other inflated Internet stocks in the 90s.
Adam uses ‘linguistic hedges’ (LH) throughout this article. A hedge is a qualifier used to mask a limited knowledge and therefore the truth value in an assertion.
>>>HDC's urine-based “test doesn't appear” (LH) to be close (LH) to clinical validation or commercialization<<<
Doesn’t appear? Or is not? To be close? Define ‘close.” A day? A week? A month? The term “clinical validation OR commercialization doesn’t even make sense. “Or” should be “And.” Commercialization is a corollary of validation. “Or” indicates he doesn’t understand the process, OR he is just a sloppy writer. Either way, he’s already lost credibility on both fronts.
>>>according to “checks” (hedging the LH) I made with HDC's partners.<<<
“Checks?” Could he be more vague? Define “checks.” It is in the best interest of all parties to adhere to their NDAs and only divulge information that is available to you and me. HDC’s partners are the two 800-pound biotech gorillas – too sophisticated to play these games. Neither would waste their resources if they didn’t think these tests had a good chance of to bolster their bottom line in the near future. Quest in particular, rarely takes on a LDT where it eventually doesn’t become part of their Directory of Services.
Yes … my name is Zenos Arrow and I’m smarter than this 5th grader.
>>>And even if a convenient and accurate urine-based gene test for prostate cancer was launched soon<<<
This whole sentence is a hedge. After all, we are talking about HDC’s test – not “a” test),
>>>it would not replace the widely used, if flawed, PSA blood test -- certainly not right away<<<
(certainly not right away) The biggest hedge in his article. He just said it would not replace a flawed PSA and then hedged by saying “not right away.” Duh! Nothing happens right away in the clinical lab industry. Most investors know that some lobbying for standard of care would be needed (already started). This lobbying will be done by various entities, one of which would be the Quests’ national managed care executives whom have successfully done this many times over with Medical Directors and reimbursement committees for all the major 3rd party payers.
>>>according to cancer experts.<<<
What cancer experts? An OBGYN is considered a cancer expert – and even some of those still believe the outdated manual Pap smear if more effective that a liquid-based, imaged-guided pap smear. All Adam is telling us is that the new Pap smear won’t replace the old paper smear “right a way.” Duh. There will still be some docs who will be slower to adopt a better technology – except if it becomes standard of care, because they want to get reimbursed for the test.
Trading in Health Discovery (HDC) surged on Jan. 29, triggered by a Biomedreports alert to its paying subscribers that morning:
>>>This "news" was more than a year old! HDC announced a tissue-based genetic test for prostate cancer ready for commercialization in the fall of 2008 after the completion of a phase III study earlier that year.<<<
Yes, I along with several others just on this board had mentioned that. Is he really getting paid for this drivel?
>>>Clarient, one of HDC's partners, launched this tissue-based prostate cancer test in January 2009 as a so-called "homebrew" or in-house laboratory test, which doesn't require approval from the U.S. Food and Drug Administration.<<<
WRONG! I’ve posted this several times! It was NEVER launched. This company has only been profitable since last year and they decided to stick to their core testing to keep up with a very competitive space under the biotech umbrella. Clarient themselves told me they were too small (no resources) to vet this test out in the market place (next move Quest/Abbott). NEVER LAUNCHED!!!!
>>>A year later, however, sales of the HDC-Clarient prostate cancer test are "immaterial," according to Clarient spokesman Matt Clawson.<<<
Huh? No follow up question Adam? You didn’t flesh out the fact it was immaterial because it was NEVER LAUNCHED!?
>>>The HDC prostate cancer test is a "very small part of our business and we don't spend a lot of time talking about it," added Clawson.<<<
I don’t believe you Adam. I believe you misquoted Clawson. The HDC test is not orderable, so it’s NOT a part of their business yet. Clarient is a specialized anatomical pathology company, so they have to concentrate (“talk about”) on their core testing … the sure things, like K-RAS and EFRG. I talked to them twice and was able to get more accurate information than you.
>>>it has a very good chance of replacing the current PSA test for multiple reasons, including the fact that HDC's urine-based prostate cancer test is non invasive (only requiring a urine sample) while the PSA test requires an invasive blood collection procedure," according to Biomedreports.<<<
HUH? First of all, the speculation is about replacing the PSA as a screening test for prostate cancer. Our test will not replace a test that detects prostate-specific antigens. Our test will detect the genetic evidence for prostate cancer. Why would Adam omit that, and only mention the speculator’s benefit of the test being non-invasive. Non-invasive is NOT a compelling reason for this test.
>>>Quest Diagnostics, one of the country's largest laboratory testing companies<<<
WRONG AGAIN! It IS the largest testing company. How does Adam not know that?
>>>confirmed for me that it did license from HDC last year the rights to develop a urine-based aimed at detecting aggressive or clinically significant prostate cancer.<<<
Why would you even have to confirm such a thing? He must be getting paid by the hour.
>>>Quest is also working with technology from other companies to accomplish the same thing.<<<
Of course they are working with other companies - but not on a urine screening test that is also going through the FDA process by the King of Biotechnology (Abbott). Quest is working on assays to detect clinically significant PC as a form of prognosis, reoccurrence and to manage the disease (stratify it). The “same thing” you mentioned doesn’t reflect the clinical utility of our test.
>>>Quest spokeswoman Wendy Bost declined to say how close such a test is to reaching the market but she did say that any urine-based test for prostate cancer from Quest would not replace the PSA test.<<<
Of course not, because the inexpensive PSA test doesn’t test for prostate cancer. Although it won’t replace the PSA test for measuring the spikes in the antigens, it will replace it for a screening test for prostate cancer. The PSA test will still be used as part of a battery of tests to help measure and monitor the disease – along with other testing.
>>>"Our research and development activities center on developing new techniques, employing urine and tissue specimens, that can complement, not replace, PSA testing. PSA testing plays an important role in the detection of this cancer. This role could be more powerful if the results of other validated biomarkers are available to physicians for assessing, in concert with a PSA result, a patient's likelihood for malignancy prior to biopsy or surgery," said Bost, in an email.<<<
This is exactly what a spokesperson should say about a test that is still going through clinical trials. The experts recommend several approaches to detect, stratify and monitor the disease. The PSA, with only a predictive value of 49% (when used in conjunction with a DRE), will not be the main player in the detecting process.
>>>Abbott Labs spokeswoman Adelle Infante, likewise, confirms the company is working with HDC's urine-based prostate cancer screening technology, but "we are still early in the development process," with initial studies only underway, she said. Any test coming out of Abbott's labs will have to first be approved by the FDA before it reaches the market, she added.<<<
Again, we know this (or at least most of us). FDA in clinical lab is a 3-year process – I’ve mentioned this several times. The LDT is usually a third of this time frame. And yes, investors should know that “kits” need to go through the FDA approval process. Seems like an attempt to instill fear and doubt in the LDT process.
>>>Clarient also has rights to develop a urine-based prostate cancer test based on HDC technology, but any such test is "not ready for commercialization," said spokesman Clawson.<<<
ARRGGG! You are repeating yourself! Not ready, because Clarient doesn’t have the resources. Clarient is not ready to commercialize it for reasons I mentioned earlier – straight from Clarient themselves.
>>>HDC won't say much about the timelines for a urine-based prostate cancer-screening test, nor does the company have any clinical data to share on such a test. HDC spokesman Tom Gallagher said the company is restricted by confidentiality agreements with its partners.<<<
Yes, why is this news that HDC is restricted by confidentiality agreements.
>>>Gallagher declined to provide details about any clinical trials specifically investigating the accuracy of a urine-based prostate cancer test that relies on the HDC-discovered genes that allegedly signal aggressive tumors. On several occasions, Gallagher promised to connect me with HDC CEO Stephen Barnhill, but he never followed through.<<<
Quest and HDC better not disclose this until they are ready to launch. This IS NOT the FDA process – Quest will not show their cards to the competition.
>>>Researchers working on behalf of HDC did publish a paper in the journal UroToday International last year on the company's tissue-based test, but no details about extending the technology to urine-based screen were included, nor has the FDA reviewed the data.<<<
Because that data was not available. A little bit of digging would have uncovered this.
>>>Other companies and research groups are busy working on developing urine-based tests for prostate cancer. The diagnostics firm Gen-Probe(GPRO Quote) already sells a urine test for prostate cancer in Europe. The company is now running clinical trials in the U.S. with plans to get the test approved here.<<<
But this has nothing to do with the clinical utility of HDC’s test. Gen-Probe’s PCA3 test is not more sensitive than the current PSA test. In other words, it doesn’t detect the presence of prostate cancer any better than the “flawed” current PSA test. Our urine test will have a high sensitivity and specificity. The high sensitivity will allow the test to be used for screening. I posted months ago that I thought it was a telling thing that Quest’s competitor (LabCorp) was marketing their PCA3 product. Right on their website it states that this test IS NOT a screening or a diagnosis test. It only differentiates (specificity) between cancer and BPH.
>>>A need does exist for a better way to screen patients for prostate cancer because the current PSA test is not specific enough, which means it doesn't do a good job of distinguishing between non-cancerous conditions like an enlarged prostate and serious, aggressive cancers, says Dr. Otis Brawley, medical director of the American Cancer Society.<<<
I’m sure this was a miss-quote, or an omission of parts of his quote (a “hoist by his own petard” situation for Adam). Specificity is only part of the equation; the low sensitivity – the ability to pick up a problem with the prostate – is the first line of the screen. If it doesn’t pick up something, then specificity is a moot point.
>>>But any new prostate cancer test that is developed will need to be reviewed and approved by the FDA. Then, it will take years of follow-up data before doctors are comfortable replacing the PSA test completely, Brawley says.<<<
Another miss-quote. Dr Brawley is well aware that a Lab Developed Assay in a CLIA-Certified lab, with FDA instrumentation, reagents etc… do not have to go through the FDA process. The CLIA process has been the norm for these assays – and clinical laboratory scientists will be quick to educate those that suggest more FDA oversight is needed.
>>>"This is not something that is going to happen overnight," he added.<<<
Duh, repetition is not going to make your drivel less specious.
>>>Meantime, HDC issued Tuesday what has to be the most far-fetched and ridiculous press release I've seen in a long time.<<<
Well that sounded objective and credible Adam.
>>>The company announced it was completing a mobile phone application that will allow anyone to take a picture of a suspicious mole on their bodies, email the photo to HDC, then immediately receive back a report outlining a risk assessment for melanoma.<<<
Wow, you got one right Adam!
>>>Any company that claims to be able to diagnose skin cancer<<<
Oh no Adam. That was short-lived. The company is run by laboratory scientists that understand the only way to definitively diagnose cancer is via a manual observation of tissue cells, from a biopsy, under a microscope, BY A PATHOLOGIST! The offer is a risk assessment, not a diagnosis. Please, at least learn the clinical laboratory lexicon.
>>>acting completely irresponsibly, even recklessly, because it puts peoples' lives at risk. Hopefully, the FDA learns about this nonsense and orders HDC to cease and desist before someone gets hurt.<<<
I hope your governing body looks at this crap you just published. The fact is, dermatopatholgy exam is based on a visual inspection of any suspicious moles/growths. My Derm looked at a chest mole of mine last year and immediately said “Basal Cell Carcinoma.” And stated that of course they would have to have this biopsied, but she was almost certain. And of course, the biopsy gave a DIAGNOSIS of Basal Cell Carcinoma.
>>>By the way, Biomedreports described the mobile phone app for skin cancer as "impressive" and "good news." I'm gobsmacked. Is there anything Biomedreports won't do or say to promote penny biotech stocks?<<<
I’m gob smacked you’re even covering this industry. Please go back to software. You are a hack with an agenda.
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