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Chembio Provides Business Update
Date:1/3/2012

e would then immediately apply for CLIA waiver, which is expected to take between 1 and 3 months to be granted.
  • Syphilis - As a result of our having received a CE Mark for the product in Q3'11 and our business development efforts during Q4'11, we have established several European distributors for this product.  We expect to start to see some revenues from these distributors as we get further into 2012 and local evaluations and business plans are established by each distributor. For the US market, we have decided to restart the clinical study in Q1'12 incorporating the use of  a reader which we believe will enable more consistent determination of testing results. We expect to complete the clinicals in Q3'12, and  make the 510(k) submission  in Q4'12. Therefore we expect FDA 510(k) clearance would be in Q1 or Q2 of 2013, followed by commercial launch in the US.
  • SURE CHECK HIV OTC Study - We have made progress toward completing the requirements for submitting an IDE application.  We believe that this year (2012) there will be external events that will help us to better define the market opportunity. This principally includes a meeting of the FDA's Blood Products Advisory Committee (date not determined yet) that is likely to result in a final recommendation concerning a competitor's application for OTC use of its HIV test. Assuming it is recommended, and the product is actually launched, we will be able to assess the market approach and its reception by their targeted consumers.  This information will help us before we commit additional significant sums to this program.  We can do this knowing that we are the only company other than this competitor that has a device that is qualified to begin the studies necessary to gain OTC approval.  In the meantime we are participating in a field study that will provide us with additional data that will be useful in conducting the trials.
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  • SOURCE Chembio Diagnostics, Inc.
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