CPGR will be developing multiplex protein array-based antibody profiling assays and related bioinformatic analysis methods for the project with the ultimate aim of creating a biomarker signature that can be used for companion diagnostic purposes.
The study supports the idea of more widespread nucleic acid-based HIV diagnostic testing, which could be a boon for Gen-Probe and Novartis Diagnostics, which offer the only approved NAT for qualitative HIV diagnosis in the US.
"The discovery of svRNAs that play a critical role in flu virus replication opens the door for the development of novel RNA therapeutics for the treatment of flu infection, an area of major unmet need," according to an Alnylam official.
The studies surmise that multiplex PCR respiratory virus assays, such as those offered by EraGen, Seegene, Luminex, and Qiagen, perform as well or better than traditional fluorescent antibody tagging and cell culture methods at detecting respiratory viruses in clinical specimens.
At last week's Sample Prep 2010 meeting in Baltimore, Md., microfluidics, integration, and automation were oft-cited as future market drivers in the area of sample prep for virus, toxin, and pathogen detection.
The vote of confidence is a stepping stone for the company to seek 510(k) approval for an H1N1 test on its platform; to tackle the point-of-care diagnostic market; and to further develop tests for other infectious diseases.