DIY Lab Tests Getting More Capable 85
the_newsbeagle writes "People who are into the quantified health trend can already measure and chart a wide variety of metrics — steps taken, calories burned, heart rate, blood pressure, sleep patterns, etc can all be tracked using new gadgets. Now a new device called Cue lets people track their biochemical stats, too. Cue offers five DIY lab tests, automates the testing procedure, and sends the results to the user's smartphone. It lets guys check their testosterone levels, ladies check their fertility status, and also offers tests for the flu virus, vitamin D levels, and an inflammation-marker protein. Apparently more tests are expected down the line."
FDA letter in 30 days and counting (Score:5, Insightful)
No, it's 'not diagnostic' - it's 'only investigational' so they aren't trying to get FDA approval. Right. That ought to be amusing.
It's just the same solid phase chemistry that is used in our clinic analyzers. We have a bunch of little hand held units (which in the case of the Cue is replaced by the phone and app). The chemistry is well tested, if a bit spendy - we don't use these for most tests, usually as backup in case the big analyzer has a hissy fit or if we have to take it in the field or if you are doing really rapid testing.
So, it's really just a marketing campaign to see if they can get people to buy the cartridges and a legal campaign to see if they can outrun the FDA.