Monday, September 06, 2010 11:51:04 AM
My understanding is any detection method goes through a validation process by organizations having expertise in the field. There is no indication from the company in its SEC filings that FDA approval is required. Nor is there any indication on the FDA website that it has approval authority over a detection method. Here is Appendix 1 from the FDA's Bacteriological Analytical Manual that covers rapid methods for detecting foodborne pathogens.
http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/ucm109652.htm
Here is indication that the approval method is more of a peer-acceptance technique.
Bacteriological Analytical Manual (The BAM) is a collection of procedures preferred by analysts in U.S. Food and Drug Administration laboratories for the detection in food and cosmetic products of pathogens (bacterial, viral, parasitic, plus yeast and mold) and of microbial toxins. The manual's contents reflect the history of methods development described above. Except for some rapid methods listed in Appendix 1, all these methods have been used and peer reviewed by FDA scientists as well as by scientists outside FDA. However, not all of these methods have been fully validated by collaborative studies. In some instances, collaborative studies are not possible because uniform test samples can not be prepared (as with encysted parasites). In other instances, FDA needs to use a method before the time it takes to achieve full validation.
http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/ucm071363.htm
YMB Post Link: http://messages.finance.yahoo.com/Business_%26_Finance/Investments/Stocks_%28A_to_Z%29/Stocks_M/threadview?bn=75402&tid=64&mid=66
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