The DNAcowboy

Molecular Biologist, Macintosh Geek, Musik Freak

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The Tables serie: Table 1-Highly Integrated Molecular Diagnostic Platforms

This is the 1st table of a serie of 3 on automated platforms in Molecular Diagnostics that will be available exclusively at Coffee And Sci(ence).  You can find it here:
Table 1-Highly Integrated Molecular Diagnostic Platforms 
Back in 2004, when Roche Molecular Diagnostics had introduced the Cobas Ampliprep + Cobas Taqman 48 in Europe, there was not too much instruments capable of such integration of nuclec acid extraction (NA) and realtime PCR (rtPCR) detection. Now (Nov. 2007), there is a bunch of them. Abbott, BD, Biomerieux, Cepheid, Gen-Probe, HandyLab, Iquum, Qiagen, Roche Diagnostics and Siemens Medical Solutions Diagnostics. If you are not here, please contact us.
Integration is essentially coming from the combination of 2 instruments, 1 for NA extraction, one for rtPCR. Abbott, Biomerieux, Roche and Siemens are the majors. They basically use Tecan, Hamilton, PSS based platforms for NA extraction combined with a rtPCR thermocycler from AB, former Organon-Teknika, Roche, Stratagene. Transfer of sample between instruments is manual, except for Roche who has produced the Docking Station, a robotic interface whichacts as a PCR plate conveyor.
I have mentionned Qiagen in this table because they have so much NA extraction platforms available and a long list of Molecular Diagnostic (MDX) reagents. However, Qiagen is still missing a rtPCR platform. Artus Biotech, before their acquisition by Qiagen, had a collaboration with Corbett Research around the RotorGene 3000. But Qiagen is not mentionning this partnership anymore. Hopefully they are on the market to find a solution.
Gen-Probe and BD have a different approach in that sense they are fully integrated instruments in a single box. Gen-Probe’s Tigris is the precursor of such category of instruments. Respect for that. But come on, this is a « Qual » platform, not a Quant. BD’s Viper is almost of a same age, however, BD has added very recently this fully integrated capacity to the Viper which is now capable of sample prep, SDA setup, and detection. But the specs of this later are still unclear. There is no mention at all of this platform in the real world, except in meetings and on BD’s booth. Is that rtSDA? I’m not sure.
Finally, a more recent category of platforms, the benchtop fully integrated MDX platforms, with Cepheid, Iquum and HandyLab. Cepheid is here the precursor with the GeneXpert4. They recently launched the GX1 and GX16 which are the younger and bigger bros of the GX4. Iquum is working on its Lab-in-a-tube technology since 2004. Hopefully we’ll see the Liat available soon. HandyLab has shown more recently their PCR chip based technology within their upcoming Jaguar platform.
Whoever will succeed the best, Cepheid, HandyLab and Iquum are clearly building the future of MDX platforms. Nanosphere’s Verigene system 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 steps. 

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Nanotechnology finally hit the Mdx market with Nanosphere

Nanosphere Verigene

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.

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