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Home Access Health files pre-market approval (PMA) for home HIV test

This article was originally published in Clinica

Executive Summary

Home Access Health (US) has filed its HIV home-testing service with the US FDA for pre-market approval. Home Access, which specialises in telemedicine and will use Waldheim Pharmazeutika's HIV-1 test, is the third company to submit a home testing service for US approval (see Clinica No 655, p 17). Home Access believes that the US market for home HIV testing could be worth as much as $600 million, with nearly 30 million Americans keen to purchase kits.

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