AAV will now need to be handled at BSL2 instead of BSL1.
New research demonstrates that Adeno-associated Virus (AAV) can integrate into known cancer driver genes in cells, leading to formation of tumors (i.e., insertional mutagenesis). The research, published in Nature Genetics [Oct. 2015, Vol. 47(10): 1187-1195], has found AAV genes in patients’ human hepatocellular carcinomas. This indicates a pathogenic role for virus, which is commonly used in research. In the past, AAV has been classified as a Risk Group 1 virus because it was considered a defective virus requiring coinfection with adenovirus to become infectious.
Previously, research with AAV was approved with biosafety level 1 (BSL1) containment and practices by the Duke University Institutional Biosafety Committee (IBC). The IBC feels that the newly characterized, potential oncogenic nature of this virus increases its risk to the researcher and needs to be handled with a higher level of safety awareness. New AAV vector work submitted to the IBC will require an SOP for BSL2 containment and practices. Researchers currently handling AAV at BSL1 should develop new safety standards using BSL2 containment and practices. Once an AAV is injected into an animal, animal containment may remain at ABSL1 (standard animal precautions).