FIOCRUZ receives Brazil's Anvisa regulatory approval to market Chembio's Dual Path Platform HIV 1/2 rapid test

Chembio Diagnostics, Inc. (OTCBB: CEMI), which develops, manufactures, markets and licenses point-of-care diagnostic tests, has been notified that Bio-Manguinhos, a division of the Oswaldo Cruz Foundation of Brazil ("FIOCRUZ"), has received regulatory approval from Brazil's National Health Surveillance Agency (Anvisa) to market Chembio's Dual Path Platform (DPP^®) HIV 1/2 rapid test for use with oral fluid, blood, serum or plasma samples. The approval triggers $400,000 in license revenues payable to Chembio within 120 days of the date of approval.

During 2008, Chembio signed four agreements with the Oswaldo Cruz Foundation (FIOCRUZ) in Brazil relating to products based on the Company's DPP^® technology, including this HIV test. FIOCRUZ, which is affiliated with the Brazilian Ministry of Health, is the Ministry's leading supplier for therapeutics, vaccines and diagnostic tests.

Under the agreement, a technology transfer to FIOCRUZ for this product is anticipated to occur over a five-year period, with anticipated aggregate minimum sales by Chembio to FIOCRUZ of this product and related components of $10 million over the period. Thereafter, it is anticipated that the technology transfer process will be complete and a five-year royalty phase will occur, with royalties of 4% of Net Sales as defined. In 2004, Chembio and FIOCRUZ entered a similar agreement for Chembio's HIV 1/2 STAT-PAK® and components from which Chembio has realized approximately $7.8 million of revenues from 2004-2009. Since 2009 royalty payments have averaged approximately $24,000 per quarter for that product.

Lawrence Siebert, Chembio's Chief Executive Officer, said, "This is the first product approval using our DPP® technology, and it is appropriately the first product we developed with this platform, which offers significant benefits and features. I believe this screening test will help increase the reach and accessibility of HIV testing in Brazil, which is already a world leader in HIV prevention and treatment efforts, by means of a less invasive oral fluid test."

Completion of Multiplex Product Development Phase and DPP® License Fee

The Company also reported that it has filed a Form 8-K concerning the completion of the product development phase of a multiplex product that the Company has been developing for a customer since April 2008. This development phase completion triggers payment to the Company of a $125,000 exclusive manufacturing option fee. It also permits recognition, for financial statement purposes, of a $340,000 license fee which was previously paid to Chembio in January 2009 and has been carried as deferred revenue on the Company's financial statements.