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.
You may also be interested in...
Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States
Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.
Mustang Bio Enters Race For CAR-T In Autoimmune Disease
The biotech company’s CEO talked to Scrip about plans to bring the CD20-targeting CAR-T MB-106 into an investigator-sponsored Phase I trial later this year.
Aldeyra Hopes To Refile Dry Eye Drug Reproxalap Later In 2024
Following an FDA complete response letter last November, Aldeyra has agreed with the agency on a trial design to demonstrate efficacy in ocular discomfort, which the company can complete this year.