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Autoteste INSTI HIV recebe classificação do Fundo Global para compras
  • Latin America - español

INSTI da bioLytical aprovado pela UNITAID e painel de especialistas do Fundo Global


News provided by

bioLytical Laboratories

Jul 06, 2017, 12:12 ET

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RICHMOND, Colúmbia Britânica, 6 de julho de 2017 /PRNewswire/ -- A bioLytical Laboratories, líder mundial em testes rápidos para identificação de doenças infecciosas, tem o prazer de anuncial que seu Autoteste INSTI HIV foi designado pelo Fundo Global como elegível para compra por entidades compradoras que possuem o direito a acessar os recursos do UNITAID e do Fundo Global.

O Autoteste INSTI HIV está agora disponível para ser comprado por organizações que têm acesso a financiamento da UNITAID e/ou Fundo Global para seus programas piloto de autoteste de HIV que capacitam os indivíduos a assumirem o controle de sua própria saúde.

"Estamos muito contentes por termos recebido essa designação pelo Painel de Avaliação dos Especialistas do Fundo Global", declarou Livleen Veslemes, diretor de operações de bioLytical Laboratories. "Prevendo uma demanda global significativa de um autoteste baseado em sangue, implementamos uma segunda linha de engarrafamento automatizada no início deste ano para ampliar o equipamento de produção do dispositivo para testes, que está projetado para fabricar um teste por segundo. Também estamos investindo ainda mais no escalamento de processo, otimização da instalação, expansão do depósito e automatização da avaliação do empacotamento a fim de cumprir com as projeções de mercados internacionais mantendo, ao mesmo tempo, os mais elevados padrões de qualidade de produto."

O Painel de Avaliação de Especialistas do Fundo Global para Diagnóstico é um mecanismo para expedir acesso a produtos inovadores de diagnóstico por um ano. Durante esse período, a bioLytical buscará a pré-qualificação da Organização Mundial de Saúde, junto com a aprovação de outra rigorosa agência regulatória, como a marca da CE, de sua versão de autoteste para países de baixa e média renda (LMICs, em sua sigla em inglês).

Por ser um líder de mercado em teste de HIV em pontos de atenção nos principais mercados da Europa e América do Norte, os prestadores de saúde confiam na marca INSTI, pois transmite a informação precisa e proporciona resultados instantâneos para seus pacientes. A gama de produtos INSTI reflete uma sólida base de aprovações regulatórias e científicas avaliadas por pares e sustentadas por mais de 14 anos de expertise, qualidade e inovação em diagnóstico médico.

Sobre a bioLytical Laboratories Inc.

A bioLytical Laboratories Inc. é uma empresa privada canadense voltada para a pesquisa, desenvolvimento e comercialização de diagnósticos médicos rápidos in vitro, no local do tratamento, usando sua plataforma de tecnologia INSTI patenteada.  Com uma base mundial de aprovações regulamentares, incluindo aprovação da FDA dos EUA, aprovação da Health Canada e a marca CE, a bioLytical comercializa e vende seu teste INSTI HIV globalmente e o teste INSTI HIV/Syphilis Multiplex na Europa.  A linha de produtos da plataforma INSTI garante resultados de testes altamente precisos em 60 segundos ou menos, muito mais rapidamente do que os 15/20 minutos requeridos pelos testes de concorrentes, com base na tecnologia de fluxo lateral. A bioLytical tem um programa ativo de pesquisa e desenvolvimento, com um pipeline que inclui testes para doenças tais como hepatite C, Ebola, entre outras.  A empresa também fornece serviços por contrato para adaptar a plataforma INSTI com o objetivo de cumprir exigências específicas de testes de diagnósticos funcionais e técnicos.  Para mais informações, acesse http://www.biolytical.com/.

Contato: Robert Mackie, [email protected], +1-604-204-6784

FONTE bioLytical Laboratories

Related Links

http://www.biolytical.com

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