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Genomic Health Inc. Message Board

  • BigDaddyCass15 BigDaddyCass15 May 17, 2007 4:43 PM Flag

    i will be participating in the secondary

    according to fidelity ipo dept. the expected pricing date is 5/21/07 that will put some overhead pressure on the stock until it prices they love to make a little pop on the day the shares are offered however clwr ibkr qxm and xfml did not exactly set the woods on fire!

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    • Not that I'm bashing GHDX but...
      and even though I am short, at the moment....

      I'd say its a good bet that the stock will get to
      the 11 range after the secondary...welllll then again
      its only 3 mil so....maybe 12 will be a very good

    • big daddy thanks for all the work don

    • I think that is the general idea then again if they say they are not using it for both reasons then get it approved u know if it is a viable test the doctors will do what they want with the results.

    • In a Step Toward �Demystifying� IVDMIAs, FDA
      Grants Class II Status to Breast Cancer Prognostics

      A �special controls� guidance issued by the US Food and Drug Administration last week assigned Class II status to gene-expression tests that provide breast cancer prognosis information, but are not used to make treatment decisions.

      The guidance also shed some light on the agency�s current thinking regarding in vitro diagnostic multivariate index assay devices, or IVDMIAs � tests that it considers more complex than other types of laboratory developed assays and therefore subject to FDA jurisdiction. The agency released a draft guidance on IVDMIAs last fall, but some in the industry have criticized its lack of clarity

      The new guidance, Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis, was issued three months after the agency approved Agendia�s MammaPrint test for breast cancer recurrence, making it the first FDA-approved IVDMIA.

      Originally deemed a Class III product requiring premarket approval, MammaPrint was granted Class II status � requiring only 510(k) premarket notification � after the company petitioned the agency regarding the safety and effectiveness of the product.

      FDA determined that MammaPrint � as well as future genomic breast cancer prognostics � can be considered as Class II devices if they comply with a set of �special controls� that are outlined in the guidance document.

      �The special controls guidance affirms that FDA has assigned tests that provide prognostic information only to Class II,� Paul Radensky, a health law attorney with McDermott, Will, & Emery, told Pharmacogenomics Reporter in an e-mail this week.

      Although the special controls guidance grew out of the FDA�s review of Agendia�s product, the document will have a broad industry impact, conferring de facto Class II status to all breast cancer prognostic tests and absolving device makers from having to go through FDA�s more rigorous premarket approval process.

      �That Agendia�s device was granted Class II status is significant for the whole industry and obviously for us,� Caroline Popper, regulatory affairs senior advisor at Exagen, told Pharmacogenomics Reporter this week.

      Popper added that Exagen, whose eXagenBC breast cancer recurrence test is currently under review at FDA, was pleased that the special controls guidance contained recommendations that the company had anticipated and planned for in its own submission.

      • 1 Reply to arrayman_2003
      • �We were happy and reassured that things were following in an anticipated course,� she said. �We fully anticipate that ours will be a Class II.�

        However, since the guidance only applies to prognostic tests, Genomic Health�s Oncotype DX test may still have to garner premarketing approval since it provides both cancer recurrence prognosis and predicts if a patient will benefit from chemotherapy. FDA specifies in the special controls guidance that Class II status is only for prognostic tests, and not for predictive tests used for diagnosis or to detect response to therapy.

        This distinction provides some clarity on how FDA might regulate certain algorithm-based laboratory-developed genetic tests, called in vitro diagnostic multivariate index assays. Steve Gutman, director of FDA�s Office of In Vitro Diagnostics, told Pharmacogenomics Reporter sister publication GenomeWeb News last week that the special controls guidance will �provide a general framework� for how the OIVD handles IVDMIAs.

        Agendia Paves the Way

        FDA crafted the special controls guidance with input from Agendia, following clearance of the MammaPrint test, as required under the de novo 510 (k) process. According to Agendia, the recommendations in the guidance reflect the issues raised during FDA�s review of MammaPrint.

        �The special controls guidance provides clarity to the market on FDA�s expectations concerning premarket notification requirements for gene expression profiling test systems used for breast cancer prognosis,� an Agendia spokesperson told Pharmacogenomics Reporter this week. �Agendia strongly believes that these recommendations provide assurance for the safety and effectiveness for these kinds of devices.�

        The FDA cleared Agendia�s MammaPrint test in February, making it the first IVDMIA to receive a nod from the agency. In a Federal Register notice last week, the agency explained that it had originally classified MammaPrint as a Class III device, which would have required full premarket approval. However, Agendia filed a petition requesting that the device be reclassified as a Class II, which only requires 510(k) premarket notification.

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