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Immunogenicity Testing Proves Invaluable

Immunogenicity is a measure of the immune response to a biotherapeutic drug. It is a very relevant issue affecting not only the use of therapeutic protein drugs such as mAbs but also peptides, enzymes, cytokines, growth factors, recombinant proteins, and other biological products.

FDA Delays Release of Guidance on Biomarker Qualification; Aims to Publish by End of Year

The US Food and Drug Administration has delayed the release of its draft guidance on the biomarker qualification process.

Originally slated to be released this summer, the guidance – which will detail the formal steps involved in qualifying biomarkers for FDA approval – will now be put out sometime “before the end of the year,” Federico Goodsaid, associate director for operations in genomics at FDA, told ProteoMonitor.

Biomarkers “Indispensible” in Cancer Drug Development, says Quintiles

CRO Quintiles says biomarkers give insight into cancer drug candidates’ efficacy earlier in the development process, reducing trial costs and duration.

Roche Obtains Co-Exclusive License to Develop PCR Assays Detecting Mutations in the PI3K Oncogene

Roche announced today that the company has obtained a worldwide co-exclusive license for the biomarker PI3K (phosphoinositide 3-kinase) from QIAGEN to develop real-time and endpoint PCR diagnostic assays. Johns Hopkins University owns the patent for the PI3K biomarker and has previously granted an exclusive license to QIAGEN’s wholly owned subsidiary DxS, now QIAGEN Manchester. Financial details were not disclosed.

New Multiplex Panels from Aushon BioSystems Help Measure Urinary Biomarkers of Kidney Damage during Drug Development

Aushon BioSystems, Inc., a leading provider of advanced microarray instrumentation and laboratory services for biomarker discovery, development and analysis, has launched new Human multiplex biomarker panels for the quantification of eight biomarkers related to drug-induced kidney damage, or nephrotoxicity. Recent studies identifying biomarkers for kidney injury during pre-clinical testing for certain drugs helped initiate the development of the new panels. Requiring minimal sample volume, the new multiplex biomarker panels address the need for a more rapid, sensitive and accurate method to identify and quantify renal toxicity biomarkers to assist in determining risk.