Ikonisys launches test to determine early progression of cervical cancer

I got an email a few days ago from a publicist for diagnostics company Ikonisys, asking me to mention the launch of a new test to determine the early progression of low grade dysplasia to cancer of the cervix.

Ikonisys, a leading provider of next-generation, cell-based diagnostic solutions, announced today the launch of its clinically-validated, novel cervical cancer test, oncoFISH® cervical.  Used in conjunction with the company’s proprietary CellOptics® platform, a robotic microscopy system, oncoFISH cervical provides the physician, while still adhering to current practice guidelines, with an assessment of risk of progression of low grade dysplasia to cancer of the cervix.  oncoFISH cervical will be offered as a laboratory developed test through Ikonisys’ licensed CAP-accredited Clinical Laboratory.
It sounded compelling to me, but I don’t know much about diagnostics and couldn’t really evaluate it.

So I turned to my diagnostics expert, Keith Batchelder, MD, CEO of Genomic Healthcare Strategies (GHS), and asked him if this new test is a big deal. He gave me two answers:

Short answer No, Longer answer Yes.

Why no?  This test is based on the premise that automated quantitation –using Ikonisys’s proprietary digital microscopy analysis system with reagents– of “rare cells”  gives insight into regression/progression of cervical dysplasia to frank cancer.   The premise is compelling, and may ultimately prove valid, but I don’t see enough current data (prospective) that warrants wild optimism.  It’s still hype, with more research needed. Do the number of rare cells (and/or the cells they have a proprietary FISH “stain” for) directly correlate to progression in general (there are circulating tumor cell Dx companies that have yet to gain market traction), and in particular cervical cancer?

Why yes?  Automated quantitation for diagnosis in a particular disease (like Cytyc thinprep for pap smear) is already  big business and it will become even bigger. Ikonisys is poised to be part of that wave.  The bigger picture, we at GHS believe that companies that demonstrate the clinical utility of a quantitated Dx with real data and those that move that Dx closer to the point of care will be even bigger winners.

So there you have it. Thanks, Keith.

September 25, 2008

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