NanoString Technologies and CE marking

I recently had the good fortune of corresponding with an older friend on the subject of biotechnology and pharmaceuticals.  Sometime into our talk, he showed me an article which he’d located within Nature Biotechnology; if you wish to read it, you may find it here (although it is only available with a subscription).

To give a brief summation: this piece discusses NanoString Technologies – a life sciences company specializing in gene expression profiling – and one of its more recent successes: the acquisition of a CE-mark designation, which will allow the group to sell its PAM50 breast cancer test in the European Economic Area.  It goes on to discuss the difficulties involved in the commercialization of assorted forms of laboratorical testing.

Albeit that I’ve absolutely no practical experience with the entrepreneurial side of biotech, something I read caught my attention.  I was not that surprised where NanoString’s new CE mark is concerned, given that, although external approval is involved in procuring one, it remains, if I’m correct, the manufacturer who retains responsibility for all specifications designated by the mark unless the importer distributes the product under its [the importer’s] own name.  So, this may be in some ways less risky for supporters than certain USA situations (if only because you’re going through different certification systems and regulatory bodies to sell in the EEA), and a less problematic process than FDA approval where manufacturers are concerned.

Something else struck me as odd.  I’d heard a bit about NanoString in late 2010 or early 2011, back when it first turned towards clinical diagnostics development as a revitalization of sorts (this was around the time, if I remember correctly, that Brad Gray came on as its new CEO – he’d previously been with Genzyme, a company bred of Sanofi).  At this time, the company was not yet profitable.  The breakthrough responsible for its current success occurred, I think it’s safe to say, in about July 2012, when NanoString hired senior staff with prior experience in public companies.

The patent that is the base for one of NanoString’s products, though, was invented and licensed from The Institute for Systems Biology prior to 2003, if I’m not mistaken, as NanoString was spun out of this organization in that year.  It was mentioned within the Nature article, though, that CGAP – the Cancer Genome Atlas Project – uses “…the same subtyping scheme [as NanoString] in its analyses…”.

I’d really like to look into the nature of CGAP and NanoString work prior to 2012, given what’s been said here.  Could it be easier for NanoString to achieve its regulation-mediated kit development goals because of its using the same subtyping scheme as NIH – I mean, that association, though I acknowledge NanoString’s technology is robust in a way that others like GH’s haven’t been, could be quite helpful in itself.  I would like to take a closer look at how identical these schemes actually are – if CGAP also uses the results of ISB’s research to a notable extent, in other words.  If it does, I have a feeling that this could have been of great help in structuring a functional plan for commercialization, and that NanoString’s success could, therefore, be tough for a lot of other, smaller groups to replicate.

This, in turns, makes me think of the intercompany networking side of biotech: I’m reminded by my involvement in certain research groups that, well, commercialization brings its provider good things, and that so many smaller groups are assimilated by massive forces that it’s sometimes sounder to be the party connecting small to large.  Perhaps it would be useful to create a utility – perhaps even a secured website – that could serve to connect commercial test developers with interested inventors and research institutions?  I’ve seen services along these lines succeed – I recently met a very multifaceted cleantech entrepreneur who briefly mentioned that he’d built something similar.

On a final, thoroughly different note, one which I feel far more secure in making: I did some reading on the NanoString protocol, and I find just one thing about it to be a little problematic.  It’s great in terms of responsiveness and precision, from what I can tell, but in hybridization, it employs two or so base probes per mRNA that hybridize.  I’m imagining that the drawbacks in preliminary cost must be rather large.

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