Currently, commonly-used HIV diagnostic tests in China include rapid screening technologies such as Enzyme-Linked ImmunoSorbent Assay ("ELISA") for initial screening, and using other technologies with higher specificity such as Western Blot for definitive diagnosis after the initial screening.

There are approximately 3,800 accredited HIV initial screening labs and 57 Center for Disease Control ("CDC") HIV definitive diagnostic labs in China. Positive HIV samples identified by the screening labs must be verified by one of the definitive diagnostic labs. The Company believes that the introduction of the HIV reagents will enable the screening labs to perform more accurate diagnosis in the future, which will help China further strengthen AIDS prevention and treatment efforts.

The Company recently submitted an application to register the reagents with the State Food and Drug Administration of China (the "SFDA") after a large sample clinical trial had been completed. Under normal circumstances, the SFDA would take approximately 12 months to complete the approval process. The Company has been advised that its application for the HIV reagents is entitled to a fast track approval process and expects to obtain the relevant approval in less than 12 months.

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