posted
Chembio Receives FDA Approval for Its Rapid HIV Tests; Company Expects New Market Opportunities and Revenue Growth MEDFORD, N.Y., May 30, 2006 (BUSINESS WIRE) -- Chembio Diagnostics, Inc. (OTCBB:CEMI) has received approval from the U.S. Food and Drug Administration (FDA) for its SURE CHECK(R) HIV 1/2 and HIV 1/2 STAT-PAK(TM) rapid test Pre-Market Applications (PMAs). The approved PMAs allow Chembio to market its rapid HIV tests to clinical laboratories and hospitals in the United States. FDA approval also allows Chembio to further expand its international marketing efforts into countries that require regulatory approval in the manufacturer's country of domicile. Lawrence Siebert, President and CEO of Chembio commented, "On behalf of all of our shareholders, I would like to congratulate our dedicated employees who have worked so hard for this achievement, one that has been accomplished with remarkable efficiency because of their hard work and commitment. FDA approval opens up the very important U.S. market to Chembio, one that should produce significant revenues. This importance has increased in view of the recommendations that are reportedly forthcoming from the United States Centers for Disease Control that HIV tests become a part of routine medical care for most Americans. Rapid HIV tests are essential tools for HIV prevention and treatment campaigns in the United States and globally, and these campaigns are scaling up. Chembio remains committed to being a global provider of competitively priced rapid HIV tests in order to help address this global epidemic. We expect that our rapid HIV tests will be sold in the U.S. market at higher average selling prices than our current sales to the developing world given our investment and ongoing costs related to U.S. approval, marketing and distribution."
SURE CHECK HIV 1/2 and HIV 1/2 STAT-PAK rapid tests are easy to perform. They are highly sensitive (99.7% for HIV-1 and 100% for HIV-2) and specific (99.9%). The tests have a rapid turnaround time of approximately 15 minutes. They are safe to use, requiring a very small sample of whole blood (as little as 2.5-5.0 micro-liters which is approximately 1/10 of a drop of blood), easily obtained with a finger prick. Chembio's FDA PMA approval is for use not only with finger-stick whole blood samples but also with venous whole blood, serum and plasma samples. Both products have a built-in internal control (a true IgG), which gives confirmation of sample addition as well as valid test performance.
-------------------- buy low sell high, but the monkey never learns Posts: 1 | From: Oregon | Registered: May 2006
| IP: Logged |
UBBFriend: Email this page to someone!
Printer-friendly view of this topic
