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Invivoscribe anuncia aprovação da FDA para distribuição do Ensaio de Mutação LeukoStrat CDx FLT3 como um Kit IVD nos Estados Unidos
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News provided by

Invivoscribe, Inc.

May 19, 2020, 11:14 ET

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SAN DIEGO, 19 de maio de 2020 /PRNewswire/ -- Invivoscribe oferecerá Ensaio de Mutação LeukoStrat® CDx FLT3 como um kit aprovado pela FDA com software de análise.

Em 2017, o Ensaio de Mutação LeukoStrat® CDx FLT3 da Invivoscribe se tornou o primeiro teste FLT3 aprovado pela FDA como serviço de teste no LabPMM, o laboratório clínico da Invivoscribe em San Diego. Essa aprovação de suplemento PMA pela FDA proporciona aos clientes uma escolha para comprar os kits de Ensaio de Mutação LeukoStrat® CDx FLT3 rotulados pela IVD para testes domésticos. Espera-se que a capacidade de realizar testes FLT3 eficientes, precisos e objetivos em laboratórios regionais, centros de tratamento de câncer e hospitais melhore a administração de pacientes diagnosticados com leucemia mielógena aguda (LMA).

Como o diagnóstico da empresa para midostaurina (EUA, UE, Suíça, Austrália), fumarato de gilteritinibe (EUA, JP, UE) e hidrocloreto de quizartinibe (JP), o LeukoStrat CDx é o único teste de mutação FLT3 globalmente padronizado validado para satisfazer padrões regulatórios internacionais para detecção de mutações genéticas no gene FLT3, que é uma das mutações impulsionadoras mais importantes na LMA. O Ensaio de Mutação LeukoStrat® CDx FLT3 pode ser usado como um auxílio na avaliação de pacientes com LMA para tratamento com terapias direcionadas ao FLT3 aprovadas.

"O lançamento do kit rotulado do IVD vai beneficiar pacientes afligidos por LMA e é uma ferramenta crítica para prestadores de saúde a fim de identificar o tratamento mais apropriado para pacientes recém-diagnosticados ou com LMA mut+ FLT3 recidiva/refratária", declarou Jeffrey Miller, diretor de estratégia e CEO da Invivoscribe.

Uso intencionado nos EUA
O Ensaio de Mutação do
LeukoStrat® CDx FLT3 é um exame de diagnóstico in vitro baseado em PCR voltado para detectar mutações de duplicação interna em tandem (DIT) e domínio de tirosina-quinase (TKD, na sigla em inglês) no gene FLT3 em DNA genômico extraído de células mononucleares obtidas de sangue periférico ou aspirados de medula óssea de pacientes diagnosticados com leucemia mielógena aguda (LMA).

O Ensaio de Mutação LeukoStrat® CDx FLT3 é usado como um auxílio na avaliação de pacientes com LMA para quem o tratamento RYDAPT® (midostaurina) está sendo considerado.

O Ensaio de Mutação LeukoStrat® CDx FLT3 é usado como um auxílio na avaliação de pacientes com LMA para quem o tratamento XOSPATA® (gilteritinibe) está sendo considerado.

O exame é para uso no Analisador Genético 3500xL Dx.

Sobre a Invivoscribe
A Invivoscribe tem se concentrado em Improving Lives with Precision Diagnostics® (em português, Melhorar Vidas com Diagnóstico de Precisão) há mais de vinte e cinco anos, promovendo o campo da medicina de precisão ao desenvolver e vender reagentes padronizados, testes e ferramentas de bioinformática a mais de 700 clientes em 160 países. A Invivoscribe também tem um impacto significativo na saúde global ao trabalhar com empresas farmacêuticas para acelerar aprovações de novas drogas e tratamentos ao apoiar pesquisas clínicas internacionais, desenvolver e comercializar diagnósticos complementares, bem como proporcionar expertise tanto serviços regulatórios quanto laboratoriais. Com sua capacidade comprovada de proporcionar acesso global a reagentes distribuíveis, kits e controles, bem como serviços de pesquisa clínica por meio de nossas subsidiárias internacionais de laboratórios clínicos (LabPMM), a Invivoscribe tem-se demonstrado uma parceira ideal. Para mais informações, entre em contato com a Invivoscribe em: [email protected] ou acesse: www.invivoscribe.com.

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FONTE Invivoscribe, Inc.

Related Links

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SOURCE Invivoscribe, Inc.

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