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Microcap & Penny Stocks : ADOT - BIOMODA: Profitable Technology with Purpose
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To: dexx who wrote (466)2/28/1998 9:18:00 PM
From: Mark Haythorn  Read Replies (1) of 4650
 
No, they still need to prove to the FDA that the test works. In fact, the reagents as well as the test device must get clearance.

Keep in mind that this isn't the same as getting a drug approved. I don't know how long it takes to run enough tests in order to submit your device/test kit to the FDA, but I notice on www.fda.gov/cdrh that a great many products are approved with just a few months, some as quick as one month (I searched for 'coulter' in the searchable 510K section of the page. Some of their blood analyzers were approved within one month of submission.

My co. was looking to license a test kit for a bacterial infection- the licensor was able to get FDA approval quickly, but couldn't manufacture the kit in any kinda quantity. Again, I seem to recall the recent ADOT press release saying that a major laboratory might license the lung cancer test- if it's someone like Roche or SmithKline Clinical labs, we should set-up a place in the house to start piling our profits!
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