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The US Food and Drug Administration has delayed the release of its draft guidance on the biomarker qualification process.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

NIH to Fund Research on Alcohol-related Biomarkers

The National Institute on Alcohol Abuse and Alcoholism aims to fund small businesses and support the technology transfer of new biomarkers that can be used to detect alcohol-related organ damage and fetal exposure to alcohol, according to a new NIAAA grant notice.

Spinal-Fluid Test Is Found to Predict Alzheimer’s

Researchers report that a spinal fluid test can be 100 percent accurate in identifying patients with significant memory loss who are on their way to developing Alzheimer’s disease.

Although there has been increasing evidence of the value of this and other tests in finding signs of Alzheimer’s, the study, which will appear Tuesday in the Archives of Neurology, shows how accurate they can be. The new result is one of a number of remarkable recent findings about Alzheimer’s.

After decades when nothing much seemed to be happening, when this progressive brain disease seemed untreatable and when its diagnosis could be confirmed only at autopsy, the field has suddenly woken up.

USC Studies Nitric Oxide’s Link to Asthma

Children with elevated levels of exhaled nitric oxide (FeNO) are at increased risk for developing asthma, particularly among children without a parental history of the disease, a study by researchers at the Keck School of Medicine of USC has found. The study is published in the European Respiratory Journal.

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.