Nanosphere, Northbrook, IL, has recently received the 1st FDA agreement for a pharmacogenetic test based on nanotechnologies AND microarrays. Nanosphere has been quiet about this announcement, but this is a huge progress in the molecular diagnostic business.This is the 1st genetic test to my knowledge to use microarrays without PCR upfront.Yes, this is direct hybridization onto a glass array, after a regular nucleic acid extraction step.Yes, it is fast, less than 90 minutes and you don’t even notice you are working with microarrays because everything is performed into a tiny little cartridge.And yes, it is supposed to be cheap, presumably in the 30 to 50 USD range.Could you imagine that?Also, this is a 2 instruments platform, The Verigene, an hybridization station and a reader, with a design which is a real breakthrough in this industry. I’m wondering if there is any iPod connection in this one?The announcement is about Nanosphere’s Warfarin assay, a SNP genotyping assay for CYP2C9 and VCORC1 alleles identification. Knowledge about these genotypes will determine patient’s ability to metabolize the anti-coagulant medication Warfarin.Nanosphere is thus the 1st company to provide a warfarin assay, ahead to many others like Osmetech (eSensor based platform), Luminex (Tm Bioscience based), Autogenomics (Infinity based platform)…etc.It is also a strong sign to the leader of this industry, Roche Diagnostics, smaller companies can also enter the market of microarray based diagnostic.Nanosphere is not a one shot product company. It is known that their Factor II, Factor V, CF assays are actually being investigated by the FDA. I guess that they will soon be approved.Then, Nanosphere will show the world of IVD, how their technology works even better with protein detection, with level of detection far better than what we have access today. Take a close look at their recent publication on HIV p24 detection (J Acquir Immune Defic Syndr Volume 46, Number 2, October 1, 2007) and understand why nanotechnology will rule the world of IVD in the following years.My congratulations to the Nanosphere team.
[...] who has recently been approved by the FDA for various MDX assays, may also be part of the game. See this blog elsewhere, and remember Nanosphere is not using anymore PCR [...]
welcome
iPod connexions to everything should be mandatory by the FDA