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Cerner Corporation Message Board

sonomaca 901 posts  |  Last Activity: Dec 18, 2014 7:25 PM Member since: Dec 18, 1998
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  • Reply to

    Scientific advisory committee at CEMI

    by rehdvm2004 Dec 18, 2014 6:11 PM
    sonomaca sonomaca Dec 18, 2014 7:25 PM Flag

    They have reagent deal with IBT. There must be a reason why they haven't done what you advocate. Availability? Cost?

  • sonomaca by sonomaca Dec 18, 2014 2:18 PM Flag

    It's DPP HIV/Syph for US market. I don't think this is going to be easy. However, if they're on track to get it done by, say, 2016, that'll be big. Talking at least $10 million in rev the first year.

  • Reply to

    Something's Wrong Here....

    by sailingaway82 Dec 18, 2014 11:08 AM
    sonomaca sonomaca Dec 18, 2014 2:12 PM Flag

    True. Also, there's a bit of an info vacuum regarding CEMIs various initiatives

  • Reply to

    Stock Drop

    by deces124 Dec 18, 2014 12:06 PM
    sonomaca sonomaca Dec 18, 2014 2:10 PM Flag

    No. There are 9.5 million shares, of which most are long-term holds. Something else is going on. Perhaps it's Determine Combo. Could be LS dumping again. Maybe someone knows something. In my view, it's a hangover from Ebola week, where traders came in trying to ride a wave and got stuck with 2 million shares. Now, they're looking for losses at year end.

  • sonomaca sonomaca Dec 18, 2014 11:07 AM Flag

    Listen, TRIB got their syph product grandfathered in. The FDA told LS that, not only will you not be grandfathered, but you've got to go PMA route. He really did #$%$ someone off over there. Publicly lambasting the FDA on conference calls isn't a great idea.

  • Reply to

    Everybody and their brother

    by sonomaca Dec 17, 2014 4:55 PM
    sonomaca sonomaca Dec 18, 2014 10:43 AM Flag

    Stock drop could be that, although everyone knew this day was coming. Could be LS selling again. Could be some bad news which isn't yet public. The only thing which could really cause a precipitous drop would be either a Sperzel or an Esfandiari departure.

  • working on Ebola. People getting money left and right to develop Ebola POC tests. Got solar powered devices, battery operated, cloud connected, you name it. You've got for profits, not-for-profits, university professors, and so on and so forth. Looks like the Alaska gold rush out there. People are hauling giant suitcase test kits into the jungle. Computer geeks who haven't got a clue about disease or Africa or POC testing or Ebola are proposing ridiculously elaborate "connected" testing networks. It would be funny if it weren't so sad.

    In the end, the experienced POC device makers are going to figure this out first and best. I'm hoping that CEMI will be one of the winners.

  • Reply to

    Stock price drop

    by sonomaca Dec 17, 2014 2:31 PM
    sonomaca sonomaca Dec 17, 2014 3:33 PM Flag

    Could be the impending increase in margins due to lateral flow patent expiry. Statsure might want a cut of that new action.

  • Reply to

    Stock price drop

    by sonomaca Dec 17, 2014 2:31 PM
    sonomaca sonomaca Dec 17, 2014 3:18 PM Flag

    They had been a lawsuit some 8 years ago that was settled. I guess Statsure isn't happy with current state of the settlement.

  • Reply to

    Stock price drop

    by sonomaca Dec 17, 2014 2:31 PM
    sonomaca sonomaca Dec 17, 2014 3:16 PM Flag

    Partner Statsure is suing CEMI. Not sure what went wrong there.

  • sonomaca by sonomaca Dec 17, 2014 2:31 PM Flag

    Not really sure if it's all related to Determine combo waiver, or if there are other "unknown" (at least to me) reasons.

  • Reply to

    Way OT: OPEC

    by mo.scuba Dec 15, 2014 4:16 PM
    sonomaca sonomaca Dec 16, 2014 7:17 PM Flag

    The US coddling of Iran has created a very dangerous situation for the Saudis. With the recent takeover of the Yemeni capital by Iran's rebel allies, Saudi is almost completely encircled by Iran. An Iranian nuclear weapon will all but force Saudi to become an Iranian client, unless of course the Saudis get one too. Their best play is to hit Iran hard in the wallet, before the sanctions regime is completely dismantled and before Iran has a nuke.

    If Obama would just get a bit tougher with Iran (and with Russia), the Saudis wouldn't feel the need crash oil prices.

  • Reply to

    HIV-Syph to the fore

    by sonomaca Dec 16, 2014 1:50 PM
    sonomaca sonomaca Dec 16, 2014 1:56 PM Flag

    BTW: This test utilizes the old algo. So, TRIB managed to sweet talk the FDA, whereas LS' hammer headed approach failed. The result is that TRIB shareholders will benefit at the expense of CEMI holders, at least for awhile.

  • The move in TRIB stock over the past few days has amounted to an increase in market cap of around $50 million. This is an obvious indicator of just how big DPP HIV-Syph (or DPP Syph) would be. We know it's a priority for CEMI, but the timeline is unclear. Are we talking about a year, two, or more?

  • sonomaca by sonomaca Dec 16, 2014 12:11 PM Flag

    Got CLIA waiver for its syphilis POC test. The stockhas added $50 million of market cap over the past couple of days, which goes to show just how big is the market for this test in the US.

    Question now: what is the status DPP HIV-syph, because the market for that is huge. Unfortunately, we've lost first mover advantage.

  • sonomaca by sonomaca Dec 16, 2014 11:50 AM Flag

    The Ebola PR on October 27 also contained an overlooked note about the Febrile Illness Assay. I think everyone was so focused on Ebola, that mention of the fact that the FIA was in clinical trials in Africa, including in West Africa where Ebola was present.

    This is important for two reasons. First, CEMI is probably close to submission of FIA data to WHO and to other regulatory bodies, if that hasn't happened already. The product might, in fact, launch in early to mid 2015. Second, we now know that CEMI has a field testing infrastructure in place in West Africa where Ebola is present. This should make it far easier to run trials there, which I suspect are already underway.

    Dr. Garry, running Corgenix's Ebola tests has loose lips, bragging about how well their trials are going. CEMI has taken the opposite approach, namely extreme circumspection. I think we'll get more info about DPP Ebola and DPP FIA very soon.

  • sonomaca by sonomaca Dec 16, 2014 11:24 AM Flag

    Ceres nanosciences seems to be on a roll with this new technology. They've already got a Lyme disease test in the queue. Working on Ebola, HIV and others. No doubt CEMI is looking at this and similar technologies.

  • sonomaca by sonomaca Dec 16, 2014 10:33 AM Flag

    NL just raised cash via option exercise and sale of AUXL stock. She and Smith have been buying PDII stock hand over fist, even as the stock craters.

  • Reply to

    Way OT: OPEC

    by mo.scuba Dec 15, 2014 4:16 PM
    sonomaca sonomaca Dec 15, 2014 5:45 PM Flag

    The Saudi squeeze has the dual advantage of strangling the US shale baby in its crib while at the same time taking a hammer to Iran, which is a growing threat to the House of Saud.

    I think the US government should do whatever it takes to find prevent the demise of US shale, including purchases for the SPR and subsidies. This is a huge national security issue.

  • Reply to

    DPP HIV 1/2 Assay.......time to result

    by mjh194353 Dec 13, 2014 12:19 PM
    sonomaca sonomaca Dec 15, 2014 12:01 PM Flag

    Below is the abstract of the study, which was done in Swaziland:

    Fourth-generation HIV rapid tests (RTs) claim to detect both p24 antigen (Ag) and HIV antibodies (Ab) for early identification of acute infections, important for targeting prevention and reducing HIV transmission. In a nationally representative household survey in Swaziland, 18,172 adults, age 18 to 49 years, received home-based HIV rapid testing in 2010 and 2011. Of the 18,172 individuals, 5,822 (32.0%) were Ab positive (Ab(+)) by the Determine HIV-1/2 Ab/Ab combo test, and 5,789 (99.4%) of those were confirmed to be reactive in the Uni-Gold test. Determine combo identified 12 individuals as having acute infections (Ag(+)/Ab negative [Ab(-)]); however, none had detectable HIV-1 RNA and 8 of 12 remained HIV negative at their 6-week follow-up visit (4 were lost to follow-up). All RT-nonreactive samples were pooled and tested by nucleic acid amplification testing (NAAT) to identify acute infections. NAAT identified 13 (0.1%) of the 12,338 HIV antibody-negative specimens as HIV RNA positive, with RNA levels ranging from 300 to 10,000,000 copies/ml. However, none of them were Ag(+) by Determine combo. Follow-up testing of 12 of the 13 NAAT-positive individuals at 6 months demonstrated 12 seroconversions (1 individual was lost to follow-up). Therefore, the Determine combo test had a sensitivity of 0% (95% confidence interval, 0 to 28) and positive predictive value of 0% for the detection of acute infections. The ability of the 4th-generation Determine combo to detect antigen was very poor in Swaziland. Thus, the Determine combo test does not add any value to the current testing algorithm; rather, it adds additional costs and complexity to HIV diagnosis. The detection of acute HIV infections may need to rely on other testing strategies.

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