May 8th, 2008
Delaying a PC revolution in cell diagnosis
What if we could revolutionize medical testing, a platform as basic as a PC? Then what if every application, and every input, had to be separately inspected and approved by the FDA?
That’s life.
Iknoisys of New Haven says it has just such a platform, which it calls CellOptics. At its heart is a robotic microscope, the Ikoniscope, to fully automate cell analysis, running through up to 175 tests in succession, tripling technician productivity.
The list price is about $200,000, not bad for a sophisticated piece of lab equipment. President Paul White expects to hold that price steady for years, using technology advances to add software and capability.
So what’s the hold up?
“We need FDA clearance on each of our tests,” White explains. “Each of our software applications and reagent applications requires an FDA clearance.
“To date we have two clearances, both on existing manual tests. We are in the process of collecting data for FDA submittals for two tests this year, and there’s a very rich product pipeline.”
White is not complaining about the slow process. “The solution the customer needs is a test,” so you get approvals for each test and its components, never the core capabilities of the whole system.
“The other piece you require is the software application specific to the test as well as the reagent used to process the cell. Each is specific. To a patient each application does something different so you want that clearance.”
Thus Ikonysis’ sales force is concentrating on one small piece of the diagnostic market, a new opportunity called rare cell detection.
Right now samples must be meticulously examined, through a microscope, by a technician looking for cancer or other cellular disease. With the Ikoniscope, samples can be loaded, the technician can go out for coffee, and all they have to review are the freshly-identified cells themselves through a computer display.
Such tests are now impossible in most cases because they are so time-consuming, says Chairman Petros Tsipouras.
“There are currently 500 labs which need this automation now, in this country alone.” The opportunity here is much larger than mere automation of existing tests, he insists.
“If you take some of the tests for breast cancer and bladder cancer, the reagents are rare, and the automation is offered by two or three other companies,” not nearly on the level afforded by the Ikoniscope.
Yet Tsipouras, like White, defends the slow FDA process.
“This is clinical testing. There’s a certain inflexibility. The FDA is getting very vigilant in how it oversees tests based on a convergence from different sources.
“Most products are required to have a continous audit trail. Third party solutions are becoming more and more difficult to create in terms of diagnostic testing.”
Ikonisys can’t ask this question, apparently, but I’m just a dumb journalist so I’ll ask it.
If you have such a basic revolution in diagnostic testing, why can’t you do a blanket approval of the system and then quicker approvals on the reagants and tests themselves, especially those already approved for manual processing?
Wouldn’t that get this to the market faster, and save more lives, without real risks?
Dana Blankenhorn has been a business journalist since 1978, and has covered technology since 1982. He launched the Interactive Age Daily, the first daily coverage of the Internet to launch with a magazine, in September 1994. See his full profile and disclosure of his industry affiliations.
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| 05/08/08
