Chembio announces FDA-supported regulatory path for home-use HIV test kits

By Elaine Rigoli

Tampa, Fla., March 13 - Chembio said it is pleased by the recommendation that was given to the Food and Drug Administration's blood products advisory committee on Friday concerning proposed regulatory requirements for the approval of over-the-counter distribution of rapid HIV tests.

The committee was unanimous in its recommendation that products that are or become approved by the FDA for professional use would automatically meet the analytical sensitivity and specificity requirements that are part of the first of three phases of requirements that the committee recommended for OTC distribution, according to a news release.

Chembio said it is expecting professional market approval of two of its three rapid HIV tests, HIV ½ Stat-Pak and Sure Check HIV, during the first half of this year.

The main additional recommended requirements will be for studies to ensure that untrained users, in both controlled and intended-use settings, will be able to properly perform the tests, interpret results and fully understand the informational materials that will be required to accompany each test kit, which will include information regarding access to counseling and treatment.

Chembio is located in Medford, N.Y., and develops rapid diagnostic tests for various infectious diseases.

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