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U.S. Department of Health and Human Services

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Laboratory of Biomolecular Mechanisms

Laboratory leader: Steven Wood 301-796-0243 steven.wood@fda.hhs.gov

There has been substantial progress in determining the effect of hyaluronic acid (HA) samples of different molecular weights on RAW 264.7 inflammatory nitric oxide response to specific amounts of endotoxin +/- gamma-interferon. Several samples of HA were assayed for their endotoxin levels using the kinetic chromogenic limulus lysate assay. No direct effect of HA on the macrophage cell line has been observed; however, the endotoxin response of RAW 264.7 is under some circumstances increased---and more so if interferon gamma is present. These early data in the project agree with preliminary pilot experiments that HA may be enhancing ongoing inflammatory responses but may not be directly causing inflammation.

New genomic and genetic technologies are expected to impact CDRH in major ways. The Center is beginning to receive submissions of genomic and genetic diagnostic microarray devices and expects more--some in co-development with drug or biological therapeutics. In addition, these technologies will be used to evaluate the safety of products such as implants and materials (toxico-genomics). However, considerable technical uncertainties impede the acceptance of these products and data. The Genomics Laboratory is providing support to the Center via 1) prioritization of the technical issues affecting microarray data that impact product review, and 2) application of the new technologies to both new and long-standing problems, including medical device adverse events, identification of medical device pathogen contaminants, and safety evaluation of products. Additionally, the Cell Biology Laboratory is investigating immunotoxicity related to particular patient susceptibility, in regards to biomaterials and devices that contact patient blood.