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Qiagen NV Message Board

accurateinformation 13 posts  |  Last Activity: Feb 24, 2015 1:45 PM Member since: Oct 16, 2001
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  • Stacie Chapman’s heart skipped when she answered the phone at home and her doctor — rather than a nurse — was on the line. More worrisome was the doctor’s gentle tone as she asked, “Where are you?”
    On that spring day in 2013, Dr. Jayme Sloan had bad news for Chapman, who was nearly three months pregnant. Her unborn child had tested positive for Edwards syndrome, a genetic condition associated with severe birth defects. If her baby — a boy, the screening test had shown — was born alive, he probably would not live long.

    Sloan explained that the test — MaterniT21 PLUS — has a 99 percent detection rate. Though Sloan offered additional testing to confirm the result, a distraught Chapman said she wanted to terminate the pregnancy immediately.

    What she — and the doctor — did not understand, Chapman’s medical records indicate, was that there was a good chance her screening result was wrong. There is, it turns out, a huge and crucial difference between a test that can detect a potential problem and one reliable enough to diagnose a life-threatening condition for certain. The screening test only does the first.

    But a three-month examination by the New England Center for Investigative Reporting has found that companies are overselling the accuracy of their tests and doing little to educate expecting parents or their doctors about the significant risks of false alarms.

    Two recent industry-funded studies show that test results indicating a fetus is at high risk for a chromosomal condition can be a false alarm half of the time. And the rate of false alarms goes up the more rare the condition, such as Trisomy 13, which almost always causes death.

    Companies selling the most popular of these screens do not make it clear enough to patients and doctors that the results of their tests are not reliable enough to make a diagnosis.

    California-based Sequenom Inc., for instance, promises on its web page that its MaterniT21 blood test provides “simple, clear results.” Only far down below does Sequenom disclose that “no test is perfect” and that theirs can produce erroneous results “in rare cases.”

    Now, evidence is building that some women are terminating pregnancies based on the screening tests alone.

    And at Stanford University, there have been at least three cases of women aborting healthy fetuses that had received a high-risk screen result.

    “The worry is women are terminating without really knowing if [the initial test result] is true or not,” said Athena Cherry, professor of pathology at the Stanford University School of Medicine, whose lab examined the cells of the healthy aborted fetuses.

    Sentiment: Strong Sell

  • Reply to

    Applera Appeal

    by john.alvato Jan 28, 2015 11:24 AM
    accurateinformation accurateinformation Feb 1, 2015 7:18 PM Flag

    Seriously, they are nothing but patent trolls.

    Sentiment: Sell

  • Reply to

    Significant partnership deal is sealed

    by afrosti Feb 10, 2015 1:09 PM
    accurateinformation accurateinformation Feb 10, 2015 5:15 PM Flag

    Lie much? Why, YES YOU DO!

    Sentiment: Sell

  • accurateinformation accurateinformation Feb 11, 2015 11:19 PM Flag

    asking mofisher and bhead/bheard for any compelling reasons is asking to get spammed, insulted, and harassed by them on this board.

  • accurateinformation by accurateinformation Feb 13, 2015 12:30 PM Flag

    ENZ is clueless enough that they don't understand that their "new" HPV assay (other companies are offering the exact same thing, E6/E7 mRNA expression) is REQUIRED to be submitted to the FDA as a PMA. The FDA has made that quite clear over the last 4 years every time they have given a public presentation.

    And the cost of such a PMA is at least 6-7X more that the amount of cash ENZ has right now and it will take at least 3+ years, during which they cannot market it..

    So, a NYSDOH certification of their test is meaningless since they will most likely be getting an enforcement letter from the FDA.

    Sentiment: Sell

  • accurateinformation accurateinformation Feb 13, 2015 12:38 PM Flag

    I almost forgot to mention that morphologically classify cells from a cervical sample is called cervical cytology, regardless of the method used to do it.

    Cervical cytology tests are also REQUIRED to be submitted to the FDA as a PMA too (another 6-7X more money than ENZ has).

    Their test is also NOT UNIQUE since it was actually developed and been pushed by Onco DX for years. Onco DX has actually been selling the reagents to the test for years as ASRs when they don't even qualify as ASRs under the FDA guidance document on ASRs published in 2007.

    I imagine that is who ENZ is buying their reagents from.

    Sentiment: Sell

  • Reply to

    Performance

    by markdoninelli Feb 12, 2015 4:10 PM
    accurateinformation accurateinformation Feb 13, 2015 1:40 PM Flag

    Neither NSPH nor GNMK are good long prospects. I believe the issues with GNMK were discussed here several days ago and NSPH's severe deficiencies are well known.

  • accurateinformation accurateinformation Feb 13, 2015 3:09 PM Flag

    Remember this from 4 years ago?

    " Enzo Biochem announced today that its Enzo Clinical Labs subsidiary has reached a deal to market a test based on IncellDx's HPV OncoTect technology.

    IncellDx's test is for the prediction of patients with human papillomavirus who may be at risk of the disease progressing to cervical cancer. It detects and quantifies the expression of viral oncogenes responsible for triggering progression to cervical cancer"

    And ENZ has the nerve to call it "a new novel platform"? All they did was slap a different name on another company's test!

    Sentiment: Sell

  • accurateinformation accurateinformation Feb 14, 2015 10:04 PM Flag

    "... try and intimidate us..."

    I seem to remember that the only other poster here that refers to himself in the third person is.....norse/jtrsteel.

    Thanks for confirming that you two are one and the same.

    Sentiment: Strong Sell

  • accurateinformation accurateinformation Feb 18, 2015 1:00 PM Flag

    Actually, you are the one that is mistaken.

    Go to the USPTO website and look up who is assigned the patients and patent applications for using flow cytometer fo measing HPV E6/E7 mRNA expression as well as the morphology of cervical cells.

    It isn't ENZ! In is IncellDX using their Oncotect HPV reagents.

    The ENZ PR last week was just anothe bunch of misleading drivel. They have had to license another company's patents and the test is that of another company, only with a new name on it, newly fabricated by ENZ.

    AND it is a test REQUIRING an FDA PMA submission, and ENZ doesn't even hav a fraction of the money that requires.

    Sentiment: Sell

  • accurateinformation accurateinformation Feb 18, 2015 1:01 PM Flag

    "...patents and patent application..." Not "patients"

    Sentiment: Sell

  • Reply to

    Ann Lurie & Your Firm

    by jtrsteel80 Feb 23, 2015 3:52 PM
    accurateinformation accurateinformation Feb 23, 2015 3:54 PM Flag

    Yadda yadda yadda.

    Stop spamming the same message with each of you harassing posts.

    Sentiment: Sell

  • accurateinformation accurateinformation Feb 24, 2015 1:45 PM Flag

    Zack's last published commentary on NSPH was October 13, 2014.

    Lie much? Why, yes you do!

    Sentiment: Sell

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