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FDA to Release Theranostics Draft Guidance in Early 2005

NEW YORK, Nov. 12 (GenomeWeb News) - The US Food and Drug Administration will release a draft of its diagnostic-therapeutic companion product guideline for public comment in February, said Larry Lesko, director of the FDA's Office of Clinical Pharmacology and Biopharmaceuticals at Scientific American's Targeted Medicine conference, held here yesterday.

 

No due date has yet been set for the final companion-product document, which is expected to boost consumption of pharmacogenomic technologies, said Lesko.

 

According to Pharmacogenomics Reporter, a GenomeWeb News' publication, the "theranostics" draft guidance was originally slated for release by the end of the year.

The Scan

Researchers Develop Polygenic Risk Scores for Dozens of Disease-Related Exposures

With genetic data from two large population cohorts and summary statistics from prior genome-wide association studies, researchers came up with 27 exposure polygenic risk scores in the American Journal of Human Genetics.

US Survey Data Suggests Ancestry Testing Leads Way in Awareness, Use of Genetic Testing Awareness

Although roughly three-quarters of surveyed individuals in a Genetics in Medicine study reported awareness of genetic testing, use of such tests was lower and varied with income, ancestry, and disease history.

Coral Genome Leads to Alternative Amino Acid Pathway Found in Other Non-Model Animals

An alternative cysteine biosynthesis pathway unearthed in the Acropora loripes genome subsequently turned up in sequences from non-mammalian, -nematode, or -arthropod animals, researchers report in Science Advances.

Mosquitos Genetically Modified to Prevent Malaria Spread

A gene drive approach could be used to render mosquitos unable to spread malaria, researchers report in Science Advances.