LEX Diagnostics, a Cambridge Cluster innovator in molecular diagnostics, has submitted dual applications to the FDA seeking 510(k) clearance and CLIA Waiver status in the United States for its ...

LEX Diagnostics, a leading innovator in molecular diagnostics, has submitted dual applications to the U.S. Food and Drug ...

The Respiratory Panel RT-PCR Multiplex CE-IVD addresses a $5.6 billion ... market growing at 10.4% annually through 2034. The mSEPT9 assay, when used in early detection of hepatocellular carcinoma ...

The Respiratory Panel RT-PCR Multiplex CE-IVD addresses a $5.6 billion ... market growing at 10.4% annually through 2034. The mSEPT9 assay, when used in early detection of hepatocellular carcinoma ...

However, the emergence of multiplex PCR technology has facilitated ... in accordance with CLSI EP17-A2. The LoD assay for the Hi-PCR ® Dengue Serotyping Probe PCR Kit 2.0 was conducted using ...

Medical and consumer genetics testing innovator and Imperial College London spin-out, DnaNudge, announces that it has received approval from Ghana’s Food and Drugs Authority (FDA) to deliver its ...

The Food and Drugs Authority (FDA) has approved the deployment of DnaNudge's Multiplex PCR platform for diagnosing four-in-one respiratory pathogens in Ghana ... The stringent performance assessment ...

Medical device approval for multiplex ... to-result RT-PCR test for the simultaneous qualitative detection and differentiation of genetic material from the SARS-CoV-2 virus, respiratory syncytial ...