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Amgen, Inc. (AMGN) Message Board

mastino88 98 posts  |  Last Activity: Jan 29, 2014 2:54 AM Member since: Sep 4, 2000
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  • mastino88 mastino88 Jan 27, 2014 3:17 AM Flag

    ariosa wont be touched bfore the hammer falls at appeals court
    until then they might be look much weaker
    losing europe
    losing low cost competition

  • mastino88 mastino88 Jan 27, 2014 3:14 AM Flag

    interesting and clould only bring upside surprise

  • mastino88 mastino88 Jan 26, 2014 12:39 PM Flag

    who is that ?
    bump 2 question

  • mastino88 mastino88 Jan 26, 2014 12:39 PM Flag

    bump 1

  • QUAKE'S OPPOSITION FAILS TO JUSTIFY ALLOWING ITS
    OBJECTIONABLE EVIDENCE TO REMAIN IN THE INTERFERENCE

    acts.uspto DUT GOV ifiling/PublicView.jsp?identifier=105923&identifier2=null&tabSel=4&action=filecontent&replyTo=PublicView.jsp

  • mastino88 mastino88 Jan 26, 2014 6:03 AM Flag

    we get the low risk self payer test this year
    general low risk screening with nipt 2-3 years

  • mastino88 mastino88 Jan 25, 2014 6:10 PM Flag

    indi we are talking since 2 months over the fact that for low risk there will be a new technology

  • mastino88 mastino88 Jan 25, 2014 2:15 PM Flag

    This next NIPT will not be massively parallel sequencing, nor will it be as broad as MaterniT21. This will likely include only Trisomies 13,18 and 21, and will likely be a targeted approach to minimize COGS.
    The company believes that the US low risk market is still 2-3 years away including the need for more clinical trials, thought leader opinions, policy determinations and reimbursement decisions. The launch of the new low cost test will benefit the company where self-pay low risk patients want to have a test to cover the primary risks that concern them (i.e. 13/18/21). Many international markets do not have coverage for high risk patients at appropriate price points.
    Personal conjecture: After hearing the rationale behind the FDA 510 submission for IMPACT Dx, it would appear plausible that the company decided to get this platform approved prior to their low cost NIPT launch (both "by the end of this year"). The company has previously sized the self-pay market at 8%. If we assume 3.5m US low risk births a year, that would represent 300k tests per year. If they price this test at $300, that would result in a TAM of $90m. As opposed to launching this as a LDT, submitting this test on the IMPACT Dx should be well received. Harmony is a targeted LDT priced around $795. Illumina has announced their intent to submit their HiSeq 2500 with NIPT to FDA for approval. This would appear to be a much more expensive solution as compared with this targeted NIPT on the IMPACT Dx platform. In this scenario, the company would likely benefit from increasing their platform footprint and sales of consumables to run the test.

  • NextView is now being offered to high risk patients who test positive. This is a Chromosomal Microarray Analysis (CMA) of amniotic fluid done by CombiMatrix. CMA is recommended by ACOG and having a recommended test provider for the patient is being viewed positively. Sequenom receives a modest portion of the ASP, but does not expect this to be material this year.

    The company referenced a low cost NIPT that they expect to be released later this year. There was a GenomeWeb article written that stated the company projected the price point of this test to be similar to Maternal Serum Screens, which are in the vicinity of $100-300. This is inaccurate. The company has not made any price determination. The reference to MSS is was that the price would have to be much lower than MaterniT21 for insurers to cover it both here and internationally. The MSS test reimbursement levels are an important benchmark that will be used in determining pricing.

  • mastino88 mastino88 Jan 25, 2014 2:12 PM Flag

    NextView is now being offered to high risk patients who test positive. This is a Chromosomal Microarray Analysis (CMA) of amniotic fluid done by CombiMatrix. CMA is recommended by ACOG and having a recommended test provider for the patient is being viewed positively. Sequenom receives a modest portion of the ASP, but does not expect this to be material this year.
    HerediT "SMA, Fragile X and Ashkenazi Jewish Panel" carrier screens are now available by Quest and/or Mt Sinai. They are LDTs developed by these labs and are run on the massARRAY platform. Sequenom receives a small portion of the ASP, but does not expect this to be a material contributor to revenues.
    The 510 premarket FDA notification for the IMPACT Dx platform with Factor II and Factor V was submitted last October. The FDA guidelines for C14 are: 75% of submissions to have a decision issued within 90 calendar days. This processing timeline excludes time waiting for responses to questions or requests for additional information. The company continues to state that they expect this to be completed in C14. Also worth noting is that this submission used Factor II and Factor V as reference tests only and the company does not expect to market these tests once approved. They are submitting this to the FDA so future tests can be developed on a platform that is already approved. These tests could be third party or internally developed.
    The company referenced a low cost NIPT that they expect to be released later this year. There was a GenomeWeb article written that stated the company projected the price point of this test to be similar to Maternal Serum Screens, which are in the vicinity of $100-300. This is inaccurate. The company has not made any price determination. The reference to MSS is was that the price would have to be much lower than MaterniT21 for insurers to cover it both here and internationally. The MSS test reimbursement levels are an important benchmark that will be used in determining pricing.
    This next NIPT will not be massively parallel sequencing, nor will it be as broad as MaterniT21. This will likely include only Trisomies 13,18 and 21, and will likely be a targeted approach to minimize COGS.
    The company believes that the US low risk market is still 2-3 years away including the need for more clinical trials, thought leader opinions, policy determinations and reimbursement decisions. The launch of the new low cost test will benefit the company where self-pay low risk patients want to have a test to cover the primary risks that concern them (i.e. 13/18/21). Many international markets do not have coverage for high risk patients at appropriate price points.
    Personal conjecture: After hearing the rationale behind the FDA 510 submission for IMPACT Dx, it would appear plausible that the company decided to get this platform approved prior to their low cost NIPT launch (both "by the end of this year"). The company has previously sized the self-pay market at 8%. If we assume 3.5m US low risk births a year, that would represent 300k tests per year. If they price this test at $300, that would result in a TAM of $90m. As opposed to launching this as a LDT, submitting this test on the IMPACT Dx should be well received. Harmony is a targeted LDT priced around $795. Illumina has announced their intent to submit their HiSeq 2500 with NIPT to FDA for approval. This would appear to be a much more expensive solution as compared with this targeted NIPT on the IMPACT Dx platform. In this scenario, the company would likely benefit from increasing their platform footprint and sales of consumables to run the test.

  • I had an opportunity to chat with Paul Maier today to follow up on their recent press releases and their presentation at the JP Morgan Healthcare conference.

    The newly issued EU patent solidifies Dr Lo's IP position. It will likely not have the effect of eliminating any tests currently being marketed, but they believe competitors will have to continue to send tests to the US for processing.
    Japan market acceptance continues to be strong. The launch of NIFTY by BGI at a lower price point (with no genetic counseling), did not appear to have any impact as of yet. The company expects all competitors to try to find a way into this market, given it's importance.
    The Mayo Clinic network agreement is an important validation of the science behind MaterniT21. Mayo evaluated all tests and decided that MaterniT21 was the best.
    The 2,000 phlebotomy sites includes the Mayo Clinic network. LabCorp has 2,200. Quest has 2,800.
    The Nicox agreement was largely forced because of the CMS coding and reimbursement changes in 2013, slowing dramatically to virtually nothing. Sequenom has now eliminated all sales reps focused on this market. Sequenom restructured the pricing on the test with Nicox. The COGS is quite low, which allowed the price point to be reduced. This is expected to facilitate more self-pay patients as well provide a more attainable reimbursement level for insurance providers. A new test was referenced at the conference. It is a line extension test, as opposed to an upgrade. Both tests will be sold and marketed by Nicox. This is not expected to be a material contributor to revenues this year, given the price points, accession levels and reimbursement climate. There will be some incremental cost savings representing activities transferred to Nicox. Sequenom will be minimally profitable on this test going forward.
    NextView is now being offered to high risk patients who test positive. This is a Chromosomal Microarray Analysis (CMA) of amniotic fluid done by CombiMatrix. CMA

  • Website Content Manager Job » Job Description
    The Website Content Manager will maintain Sequenom’s online presence by creating compelling content that is on-brand acr ... with internal and external resources to ensure website content, social media, digital marketing and email...

    hired already

  • Reply to

    Maybe CBMX would be better off

    by hollandjoey Jan 23, 2014 11:31 AM
    mastino88 mastino88 Jan 23, 2014 1:34 PM Flag

    CBMX has presenation in 30 minutes at 2pm
    link is on combimatrix homepage under investors

  • Reply to

    Jan 2015 Options

    by tradergirl131 Jan 23, 2014 9:09 AM
    mastino88 mastino88 Jan 23, 2014 9:28 AM Flag

    closed them

  • European Journal of Medical Genetics

    Available online 22 January 2014

    In Press, Accepted Manuscript — Note to users
    Cover image
    Confirmation and Further Delineation of the 3q26.33-3q27.2 Microdeletion Syndrome

    a Department of Neurology, University of Kansas Medical Center, Kansas City, Kansas, USA
    b Department of Genetics, King Faisal Specialist Hospital & Research center, Riyadh, Saudi Arabia
    c Department of Psychiatry, University of Kansas Medical Center, Kansas City, Kansas, USA
    d Department of Pediatrics, University of Kansas Medical Center, Kansas City, Kansas, USA
    e Department of Anatomy & Cell Biology, University of Kansas Medical Center, Kansas City, Kansas, USA
    f CombiMatrix Diagnostics, Irvine, California, USA

  • CombiMatrix Corporation (Nasdaq:CBMX), a
    molecular diagnostics company specializing in DNA-based testing services for developmental
    disorders and cancer diagnostics, today announced that it has entered into a contractual agreement
    with Galaxy Health Network for coverage of CombiMatrix's diagnostic laboratory services.

    Galaxy Health Network, based in Arlington, TX, has a provider base of more than 400,000 directly
    contracted physicians, 2,700 hospitals and 47,000 ancillary providers. Its member base has
    currently more than 3.5 million covered lives. These members now have access to CombiMatrix's
    suite of molecular diagnostic solutions and comprehensive clinical support - specializing in
    prenatal, miscarriage and pediatric healthcare.

    Mark McDonough, President and Chief Executive Officer of CombiMatrix, noted that the partnership
    with Galaxy is another opportunity for CombiMatrix to broaden its payor geographic reach. "This
    agreement further expands our reach throughout the country providing much wider access to our
    entire portfolio of testing services, including our CombiSNP chromosomal microarray test.

    "Our partnership with Galaxy allows us to jointly educate physicians in the Galaxy network about
    the advantages of chromosomal microarray testing," McDonough said. "We believe our services are a
    vital addition to important health networks like Galaxy and look forward to a significant and
    growing commercial and clinical relationship."

  • mastino88 mastino88 Jan 23, 2014 7:17 AM Flag

    marketing is relative
    SQNM will send invasive samples to CBMX for confirmation testing (NOW already???)
    next step of "deeper" partnership would be NONinvasive sample processing

  • mastino88 mastino88 Jan 23, 2014 3:01 AM Flag

    already using CBMX microarrays on this one ?
    thx BULL

  • mastino88 mastino88 Jan 23, 2014 2:54 AM Flag

    NICE BEAR

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